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Here are the top 5 biosimilar articles for the week of October 26, 2020.

The Top 5 Biosimilar Articles for the Week of October 26

Articles

The American College of Rheumatology (ACR) has joined with other provider groups in opposing a UnitedHealthcare (UHC) plan that could increase patient out-of-pocket costs.

ACR: UHC's New Co-pay Policy Is "Disastrous" for Patients

Chad Pettit, Amgen’s executive director of Marketing and Global Biosimilars commercial lead, discusses the potential for a level playing field for biosimilars and reference products.

Part 2: Chad Pettit on “Head-to-Head” Biologics Competition

Amgen said its sales results for Mvasi (bevacizumab) and Kanjinti (trastuzumab) give it confidence that the US market for biosimilars is more viable than generally perceived.

Mvasi, Kanjinti Add Heft to Amgen's Third-Quarter Sales

Arnold Ventures suggests ways the FDA and other governmental entities can get more biosimilars into circulation, faster. 



Advocacy Group Details Solutions for Sluggish Biosimilar Uptake 

 from Amgen made clear, biosimilars are gaining ground in the biologics marketplace, but across drug categories the pace of this advance is highly uneven.

Innovator companies develop new products that capture share from biosimilars.

Reference product prices decline to match biosimilar discounts.

Regulators establish policies to favor biosimilar use.

Check out the results from our last poll:

Opposing interests make it hard to define what elements are essential for a competitive marketplace. 

Biosimilars Poll: What are the characteristics of a healthy biologics marketplace?

The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on MJH Life SciencesTM Medical World News, The Center for Biosimilars® is pleased to welcome Chad Pettit, MBA, executive director of Marketing and Global Biosimilars commercial lead for Amgen. Great to have you on.

For our first question, there have been 2 biosimilars approved all year in 2020. Some feel this is a slow pace. Why is Amgen so upbeat about the rate of biosimilar entry?

Yeah, that's a great question, Matthew, and thank you for taking time [to speak with me]. Just as a little background. Amgen has been developing biologic medicines for 40 years and we understand innovative medicine. We've invested in biosimilars. We've got a portfolio of 10 biosimilars that we're launching, with a total investment of about $2 billion. So, we're very optimistic about the biosimilars marketplace and the direction it’s going.

If you look at this point in time, which I think is really where your question’s getting to, it's really a time of remarkable change. Today, we've got 18 FDA-approved biosimilars on the market. There are more on the way. Last year was a really incredible year. We saw a 65% jump in the number of approved biosimilars and 157% increase in the number of biosimilars that are available on the market. So, when we look at this year, we really believe that the US marketplace is really poised to welcome new biosimilars in 2020 and beyond for years to come. And the competition that results from that will result in significant cost savings for the health care system.

CfB: Now for something you just alluded to, Amgen has biosimilars in the market, as well as originators, that face competition. Would Amgen's report be less positive about the market structure if [Amgen’s own] reference products weren't holding up so well against competition?

The report was developed as part of Amgen's commitment to staying at the forefront of biosimilar education. And it reveals the mechanisms that support the long-term success and the sustainability of the marketplace with biosimilars. And if you look at the big picture of what comes out from this data, the US marketplace is really well established and accelerating across the key therapeutic areas, which then creates this cost savings, and additional treatment options for physicians and patients.

Like I said, Amgen has been a pioneer in biotechnology for 40 years. We have innovative medicine, which is critical to treating major diseases across patients, and we have biosimilars, which create a competition that allows for cost savings. And so, I think if anything, Amgen is actually more credible because we look at the biologics marketplace in its totality.

CfB: Can you explain how CMS' new HCPCS [Healthcare Common Procedure Coding System] codes for biosimilars have supported improved uptake and better savings?

Yeah, that's a good question, and I think it's a bit of a technical question. I would say, and if you look at the report, we actually highlight that assigning a unique HCPCS code for each biosimilar can help promote a robust and competitive marketplace. And it really does it in 3 ways. One is having unique or separate HCPCS codes, creating a foundation for innovation by supporting a sustainable marketplace over the long term.

Secondly, because it creates a sustainable marketplace, it lowers the risks that are associated with developing and marketing these complex products that are biosimilars. And so, it allows biosimilar manufacturers like Amgen to invest with confidence in medicines that are going to compete in the medical benefit side of the US business

The third thing it does is create a level playing field for both the reference products and the biosimilars. And one of the ways it does that is by reducing some of the concerns and confusion around traceability, which shared HCPCS codes would create.

CfB: When the Amgen report talks about overall market share for biosimilars, is that CMS and private payer coverage taken together?

Yes. It looks at the totality of the market. The reality is, when you look at the market at that level, every product is going to be different in terms of the proportion of patients who are on Medicare, typically 65 and older, vs those who are receiving coverage through their employer through private coverage. So, there are going to be differences between products.

What I could comment on in terms of market share, in totality, is that if you look at the biosimilars that have launched, many of them have gained significant share for the therapeutic area where they were introduced. As an example, the short-acting granulocyte colony stimulating factors (GCSFs) have achieved more than 70% share in 5 years, and the long-acting GCSFs have achieved 20% share in the first 12 months that they were on the market.

Another example that's important for Amgen is that we just launched 2 oncology therapeutic biosimilars in the United States. And in the first year, we've achieved nearly 40% share and then 30%, respectively, for these 2 products. And in doing so, at list prices that were 15% lower than the reference product and our average selling price was 12% lower than the reference product, which creates savings for both Medicare and commercial payers.

CfB: Some think that CMS has done better at incentivizing biosimilar use than private payers. Do you agree or disagree with this statement?

You know, I think the one thing that CMS has done that I think has been really important is that it's laid a foundation for success with separate payment codes.

And what that does is it allows the reference product and the biosimilar products to compete on a level playing field. And because of that, when we look at competition, both in Medicare and with commercial payers, we're seeing really good success. Commercial payers have all the tools they need to support biosimilar competition and uptake and Medicare has created this level playing field and the results really speak for themselves.

Like I said, we had our 2 oncology therapeutic biosimilars secure nearly 40% and 30% of the market share, respectively, in their first year, which is great. That's fantastic. Then, if you look at other products across biosimilars, they're also achieving very strong uptake, which is a reflection of competition. And if you look at the benefits of competition, as competition has grown, we've seen prices fall.

For example, there was a recent Bernstein analysis that suggested that biosimilars are driving a consistent drop in average sales price between 10% to 15%. And if you look at products that have been on the market longer, so let's say up to 5 years, we're seeing a 40% to 50% decline in average sales price, and that's reflected in the trend report. I think this is really a good example of how the marketplace is not only working with biosimilar competition, but really taking off.

CfB: Many feel that biosimilars in the United States have been a failure because payment systems, such as rebates for originator drugs and PBM [pharmacy benefit manager] deals, make it difficult for biosimilars to get a foothold. What's your take on this?

Well, I think the proof is in the pudding here. If you look at the marketplace itself, we're seeing really robust marketplaces across many different sets of products. And, like I said, we're seeing an average sales price decline of 20% to 40% for products that have been on the market for 2 years, but 40% to 50% for products that have been on the market for more than 5 years. If we look at just the bevacizumab marketplace, in just the 1 year that we've had [a product] on the market, there has been a 10% decline in the average sales price.

This is a good example of how the marketplace is receptive to biosimilars and [how] stakeholder confidence, which includes payers as well as health systems and providers, is encouraging proper use.

CfB: And to build on what you just said, although we're seeing biosimilar prices declining, why aren't we seeing a commensurate reduction in reference product prices? Can we expect to see similar reduction in reference prices?

Yeah, if you look at the trend report, it does a good job reflecting the decline in reference product prices and, overall, what that means is that when you see reference product prices coming down, biosimilars launching at lower prices, and competing on price. That's the mark of a healthy marketplace and a system that's working. And that's the foundation for a longer-term, sustainable marketplace with biosimilars that ensures future investment, both for reference product manufacturers and for biosimilar manufacturers. That's something that at Amgen, since we manufacture both, is really important for us. We believe that's the way to achieve success, by creating lifesaving medicines and cost savings in the health care system.

To watch part 2 of this interview, click 

Chad Pettit, MBA, executive director of marketing and team leader for global biosimilar launches at Amgen, discussed Amgen’s recent report on the state of the US biosimilars marketplace. 

Part 1: Chad Pettit on Amgen’s Assessment of the US Biosimilar Marketplace 

Third-quarter earnings for Pfizer revealed a strong upward pattern for biosimilar penetration, despite the coronavirus disease 2019 (COVID-19).

Biosimilar revenues climbed to $424 million (up 80%), driven mainly by the recent launches of biosimilars for rituximab (Ruxience), bevacizumab (Zirabev), and trastuzumab (Trazimera) products in the United States and elsewhere, Pfizer said in an earnings 

The company also cited ongoing growth in revenues from its epoetin zeta biosimilar (Retacrit), mainly in the United States.

sales declined 21% overall for its reference product 

Enbrel (etanercept) owing to competition in Europe, Japan, and Brazil, where biosimilars of this drug are available.

Biosimilar and generic competition for Pfizer’s products that are losing or have lost patent protection was cited for an anticipated “negative revenue impact of $2.4 billion” for the full year 2020. However, success with Pfizer’s own biosimilar launches contributed to 4% overall operational revenue growth, the company said. Third-quarter revenues totaled $12.1 billion.

“In the first 9 months of the year, our biopharma business grew 7% operationally, despite a COVID-19–related negative impact of approximately 2%, driven by the strong performance of many of our key brands,” said Frank D’Amelio, chief financial officer and executive vice president of Global Supply for Pfizer.

The strong growth of biosimilars Pfizer recently launched in the United States are part of the success story, although reference etanercept (Enbrel) sales have seen major erosion.  

Pfizer's Biosimilar Revenues Soar 80%

a $65 million investment in its parent company that will help to further ongoing development of biosimilar candidates. Alvotech is based in Reykjavik, Iceland, and its parent company is Alvotech Holdings.

The funds were raised among a number of new investors and existing shareholders and are part of a larger, $100 million fundraising goal; Alvotech said it expects to close on the remaining funds shortly.

“Through strategic commercial partnerships with many of the top global and regional pharmaceutical companies, Alvotech is well positioned to accelerate the introduction and adoption of new biosimilars for patients around the world,“ said Robert Wessman, founder and chairman of Alvotech.

Alvotech has a pipeline of biosimilar candidates that include monoclonal antibodies and fusion proteins for treatment of autoimmune diseases, cancer, and inflammatory conditions.

The new investors include Shinhan, Baxter, and Athos (Strüngmann Family Office). Alvogen and Aztiq Pharma continue as ongoing investors. The majority shareholder is Aztiq Pharma, and CVC Capital Partners and Temasek have “significant” stakes in the company, Alvotech said. 

With a sizeable round of fresh capital, Alvotech hopes to bring monoclonal antibodies and fusion proteins through the development pipeline. 

Alvotech Locks In $65 Million for Biosimilar Development

Investigators from the University of Utah said they found no additional safety or clinical risks in a study of patients who were switched from originator infliximab to infliximab biosimilars. The participating institution, University of Utah Health Plans, achieved average savings of $11,508 per patient transitioned to a biosimilar.

The study findings are significant in part because health centers often start only new patients on biosimilars, for fear of destabilizing patients who have achieved disease control with the reference drug. The result is that for patients “grandfathered” to receive the reference product, the potential savings from biosimilars are forgone.

The strength of the study prompted the Academy of Managed Care Pharmacy (AMCP) Foundation to honor lead author 

 with the AMCP Foundation/CVS Health Best 

by a Resident or Fellow at the AMCP Nexus 2020 Virtual meeting on October 21, 2020.

Although multiple studies have demonstrated that switching patients with autoimmune disorders to an infliximab biosimilar is safe and efficacious, most physicians do not support nonmedical switching of patients who have achieved stability with the reference product Remicade because of concerns about effective management, patient mental health, and treatment safety and efficacy, the authors said, citing survey data.

Starting in February 2019, University of Utah Health Plans began switching all patients to biosimilar infliximab who were receiving Remicade originator infliximab. The primary end points were financial and clinical outcomes.

The study enrolled 63 patients (47.6% male, 52.4% female) ages 13 to 63 years. Savings calculations were based on the cost per 100 mg of the most recent Remicade infusion compared with subsequent biosimilar costs for the same patient. Patients included those with commercial (n = 42) and Medicaid coverage (n = 21), or 66.7% and 33.3%, respectively. Disease types included Crohn disease (47.6%), ulcerative colitis (17.5%), rheumatoid arthritis (12.7%), psoriatic arthritis (6.3%), and others.

A number of patients had been previously treated with other biologics, including adalimumab (29.5%) and etanercept (14.8%).

By April 2020, more than 90% of patients who began on the reference infliximab had been switched to a biosimilar. At a mean follow-up of 6.2 months, 44 (70%) of the 63 patients were on infliximab at the same or lower dose. Investigators said 9 patients had unstable or active disease before or after the switch and were given an increase in dosage or frequency of administration.

The savings for the health plan amounted to nearly $725,000, investigators said.

“Transitioning patients from the originator product to a biosimilar did not come with excess safety or clinical risks,” authors said. “The transition process included direct outreach via telephone to providers’ offices and was generally well accepted by all affected physicians.”

They said the findings suggest that the switching model could be applied to other patient populations. They recommended that in future investigations, patients be stratified by disease severity and treatment history to shed further light on the cost and cost and clinical efficacy relationship between reference infliximab and its biosimilars.

Parker T, Britton L, Willis C, et al. A retrospective analysis of the clinical and financial outcomes of converting patients from originator Remicade to an infliximab biosimilar. Presented at:

 AMCP Nexus 2020 Virtual; October 21, 2020. 

A study of mandatory switching for patients with rheumatologic conditions led to savings without effect on safety or efficacy.

Safety, Efficacy, and Savings Result From Study of Nonmedical Switching

With Amy Coney Barrett’s bid for a seat on the Supreme Court almost a done deal, the question in the biosimilars world is how her potential confirmation is likely to affect the Supreme Court’s pending deliberations on the Affordable Care Act (ACA) and whether the biosimilar approval pathway, which is part of that, survives.

On November 10, the Supreme Court will hear oral argument on whether the individual mandate portion of the ACA is severable from the entire statute or the whole of the ACA should be abolished, which would mean the end of the Biologics Price Competition and Innovation Act (BPCIA), which defines the biologics approval pathway. Legal experts interviewed by The Center for Biosimilars® had mixed opinions on whether Barrett is likely to side with the severable or non-severable arguments.

“Although some of Judge Barrett’s writings have questioned the constitutionality of parts of the ACA, she has not really addressed the severability issue,” said Chad Landmon, intellectual property and FDA chair for Axinn, Veltrop & Harkrider of New York, New York. This makes it difficult to read how she may vote on the issue, he said.

“Given that Justice [Antonin] Scalia was against finding severability, it’s certainly possible that she would come to the same conclusion because, in her own words, Judge Barrett shares Justice Scalia’s judicial philosophy. That being said, it’s also possible that some of the other, newer justices, such as Justice Brett Kavanaugh, would also conclude that the ACA is severable and preserve the BPCIA,” Landmon said.

Ha Kung Wong, an intellectual property attorney with Venable Fitzpatrick of New York, agreed that it’s not clear what Barrett’s opinion on ACA severability would be. In a 2017 

 Barrett discussed the challenge to the individual mandate, but does not appear to have specifically addressed the severability issue or whether she feels the parties to the case have legal standing to challenge the ACA, he noted.

“She’s most likely going to side with the conservatives on the court, but Justice Kavanaugh appears to prefer to sever provisions that are unconstitutional and not strike down whole laws, as he did in 

Barr v American Assn. of Political Consultants

, and Barrett comes from a similar conservative mold as Kavanaugh and Justices John Roberts and Neil Gorsuch. Also, Roberts previously upheld the individual mandate in 2012, based on Congress' taxing power, apparently due in part over concerns regarding the impact of voiding other parts of the ACA,” Wong said.

 originally required that individuals must maintain a certain amount of health insurance or pay a penalty for failure to do so, but the penalty portion was eliminated in January 2019, and plaintiffs may be found to have no standing to contest the ACA because they have failed to produce evidence of financial harm from the individual mandate. The court may uphold the lower court finding that the individual mandate is unconstitutional but decide that other parts of the law are valid and may stand independently, in accord with what may be perceived as the original intent of Congress when it voted on the legislation.

“We’ve seen that the ACA can operate without the individual mandate penalty, as it has done over the past year, so it doesn’t appear to be necessary for the ACA as a whole,” Wong said.

In the event of a nonseverable decision, the loss of the BPCIA could be devastating for the progress made with biosimilars, lower-cost copies of reference products that have benefited from this pathway to approval, which also adds structure to the process of resolving patent disputes, legal experts said.

“The smart thing to do would be a severability determination,” said Kevin Nelson, a partner with Schiff Hardin, of Chicago, whose practice has focused on biologics regulations. “Some of the amicus briefs have talked about that opportunity and emphasized how the BPCIA is a really a standalone provision and is not intertwined with the ACA. The responsible thing would be to segregate the BPCIA regardless of what you do with the ACA.”

The court seems primed to do this based on the philosophy that has encompassed its previous actions, he said. “There is a tradition on the Supreme Court of not striking down more of a statute than it needs to. The Supreme Court is not Congress. It has acknowledged that time and again. It’s not about rewriting laws. It’s about determining what’s constitutional and what’s not,” Nelson said.

If the Supreme Court were to rule on the side of nonseverability, it might be a very long time before Congress is able to enact a replacement for the BPCIA, he added. “We’d be asking Congress to do something that it’s having trouble doing right now, and that’s agreeing to stuff.” The election and the changes in representation it brings about would complicate the issue.

A trio of legal experts discuss Amy Coney Barrett's bid for a Supreme Court seat and how that might affect deliberations on the Affordable Care Act and the Biologics Price Competition and Innovation Act (BPCIA).

Legal Experts Weigh in on BPCIA Severability

Samsung Bioepis presented positive data from real-world switching and uptake studies of infliximab biosimilars in patients with inflammatory bowel disease (IBD) at the American College of Gastroenterology (ACG) 2020 Annual Scientific Meeting.

an 83% continuation rate among patients who were switched from reference infliximab (Remicade) to the biosimilar Renflexis. Investigators culled patient population data for the retrospective study from the US Veterans Affairs Healthcare System database.

The same study showed a similar continuation rate among patients who were switched from 

another biosimilar, to Renflexis, “reflecting the safety of switching from either reference product or biosimilar,” Samsung Bioepis said in a statement.

“Since IBD symptoms can be severe, maintaining a stable condition is important for IBD management. This study demonstrated that patients who were on infliximab, reference product or biosimilar, can remain stable after switching to another biosimilar, without major safety concerns,” said study leader Nabeel Khan, MD, an associate professor of clinical medicine at the University of Pennsylvania. 

that adoption of Renflexis, which became the preferred infliximab product on the Veterans Affairs National Formulary (VANF) in 2018, was faster than adoption of Inflectra. The latter became listed on the VANF in 2017, suggesting that providers are becoming more comfortable with the use of infliximab biosimilar agents.

“We are confident that this real-world switch data will provide additional reassurance to gastroenterologists who are treating patients with IBD,” said Seongwon Han, vice president and Medical & Lifecycle Safety team leader at Samsung Bioepis.

Renflexis was approved by the FDA in 2017. The goal of the first study was to augment data on the safety of switching in the real world. Patient data from January 2017 to May 2020 were included, and study requirements were that patients must have begun Renflexis prior to May 1, 2019, to provide sufficient follow-up. A minimum of 2 infusions of reference infliximab or Inflectra were required prior to initiating treatment with Renflexis, and patients must have switched to Renflexis after 3 months of stable IBD. The primary end point was Renflexis discontinuation at the 1-year point.

The investigators included 298 patients in the study and observed a 1-year Renflexis discontinuation rate of 17% (n = 52). They said 30 (10%) patients discontinued following cessation of response, which included development of resistant antibodies. Hypersensitivity led to discontinuation for 9 patients (3%).

The continuation rates for patients with a double medication switch (reference to Inflectra to Renflexis) and those with a standard single medication switch (reference to Renflexis) were similar: 82% and 87%, respectively.

The investigators noted that 13% of patients discontinued after loss of response or hypersensitivity reactions, leading them to conclude that switching from reference/Inflectra to Renflexis “through a single or double switch is relatively safe in a nationwide cohort of stable IBD patients.”

Rising Comfort Level for Infliximab Biosimilars

The second study described infliximab reference product use as the VANF policy transitioned to use of biosimilars. Again, the study looked at use of Remicade, Inflectra, and Renflexis. The originator drug was the preferred infliximab until May 2017, before it was replaced by Inflectra in that position from May 2017 to September 2018. Renflexis has held the preferred position since September 2018.

Patients with a treatment history may continue the nonformulary product under the VANF policy, but new patients must use the preferred product. These investigators studied 6 months of infliximab utilization data and found that infliximab products were used to treat 3488 veterans with IBD (60.2%, Crohn disease [CD]; 39.8%, ulcerative colitis [UC]) and the mean age was 52.5 years. Ninety percent of the patients were male.

The investigators said the mean time for the preferred formulary product to become the most commonly used product among veterans was 10 months for Inflectra and 2 months for Renflexis.

They said the percentage of patients treated with an infliximab biosimilar increased more than 800-fold (0.1% to > 86%) from the beginning to the end of the study. Prescribing patterns were similar in both UC and CD. The investigators noted no significant difference in utilization patterns for the various infliximab products, “suggesting that [Inflectra] and [Renflexis] are used in the same manner as [infliximab] originator.

They concluded that the rapid increase in use of these agents during the study period suggests that providers are becoming more comfortable with the use of biosimilar infliximab products in the treatment of IBD.

1. Pernes T, Patel M, Khan N. The safety of switching from originator infliximab or biosimilar CT-P13 to SB2 among a nationwide cohort of inflammatory bowel disease patients. Presented at: ACG 2020 Annual Scientific Meeting; October 23-28, 2020. P1597.

2. Johnson J, Sauer BC, Pinnell DK, et al. Infliximab biosimilar use for inflammatory bowel disease: a National Veterans Affairs experience. Presented at: ACG 2020 Annual Scientific Meeting; October 23-28, 2020. P1570. 

A retrospective analysis of data from the US Veterans Affairs Healthcare System database provides positive switching data for infliximab products.

Samsung Bioepis Presents Real-World Switching Data for Renflexis

There has been much debate recently whether comparative clinical efficacy trials are really necessary for demonstrating that a biosimilar candidate is equivalent to a reference product. Many argue that they contribute little to the weight of evidence available from other testing required by regulatory authorities, such as the FDA and the European Medicines Agency. A recent study of costs of these trials showed that they actually may end up costing more to do than the pivotal trials that led to the approvals of originator drugs.

We sat down with Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs, for her take on these requirements and whether they add meaningful data for the purposes of biosimilar acceptance.

To learn more about the study mentioned above, click 

To learn more about the United Kingdom's stance on comparative efficacy trials, click 

Podcasts

We spoke with Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs, for her take on requirements for comparative efficacy trails and whether they add meaningful data for the purposes of biosimilar acceptance. 

Not So Different: Nancy Globus, PharmD, on Whether Comparative Efficacy Trials are Necessary

 for improving biosimilar use from 44 interviews with physicians, hospital pharmacists, nurses, patients (or their representatives), and regulators across Europe.

According to the authors, both health care professionals and patients are reluctant to switch from reference products to biosimilars “because of a lack of trust in and understanding of [biosimilars].”

Their recommendations ranged from individual clinician behaviors to national policies. The recommendations addressed how to implement a switch, minimize the nocebo effect following a switch, communicate with patients about biosimilars, and appropriately incentivize health care professionals to prescribe biosimilars.

The health care professionals interviewed broadly agreed, based on the available data, that patients can be safely switched to biosimilars. However, some patients “requested studies over a longer timeframe to better evaluate the long-term effects of switching.”

Stakeholders preferred a structured and collaborative approach when implementing a switch, citing the need for a clear European regulatory position on interchangeability and switching, along with guidance on multiple switching.

Stakeholders generally opposed forced switching. According to the authors, “forcing a switch was believed to be counterproductive and could result in distrust of biosimilars.”

Patients favored starting only biologic-na

ve patients on biosimilars. Health care professionals agreed this was appropriate in some circumstances, such as shorter treatment periods.

Although the majority of studies on switching have not reported any major safety, efficacy, or immunogenicity issues, use of biosimilars is sometimes discontinued by patients who perceive problems. The authors noted, “a number of real-world studies have reported a relatively high therapy discontinuation rate among patients after switching, which was mostly attributed to the occurrence of the nocebo effect.”

Most stakeholders considered physician confidence essential to minimizing the 

. One interviewee commented, “the patient is confident when the physician is confident.”

Although most health care professionals thought patients should not be involved in making the decision to switch, some reasoned involving the patient in the decision-making process would “reduce reluctance, avoid nocebo effects, and build trust.”

Some regulators suggested that clinicians and patients be informed that biosimilars “are only authorized if their efficacy and safety profiles are shown to be equal to those of the reference product.”

Overall, health care professionals said they have a difficult time determining the appropriate amount and type of information to provide to patients. Tailoring the communication to each individual patient was considered important.

Several nurses stressed that communication should not be complicated. Health care professionals overall agreed that communication should focus on “explaining that the biosimilar is equally as safe and effective as the reference product and that patients may expect the same outcomes.” One nurse, speaking of her experience of working with patients who were switched to a filgrastim biosimilar, said, “as it was communicated that the product had all the same side effects and the same precautions were needed, there was no big deal about it.” 

Similarly, some stakeholders argued that putting too much emphasis on the switch and spending too much time discussing the switch could unintentionally cause the patient to worry and trigger a nocebo effect.

Several interviewees stressed the importance of taking patient concerns seriously. They commented on the sensitive nature of switching a patient away from a drug that had brought them into remission from a serious disease.

Patients pointed out that cost savings are a motivator only for some patients. According to the authors, “the willingness to switch may be greater in settings where these medicines are only partly reimbursed.” Other stakeholders stressed, the authors said, “it should be made clear to the patient that less expensive does not equal inferior.”

Physicians and pharmacists also voiced concern that the benefits of biosimilar use are an important motivator, but often are not communicated clearly.

Most physicians and pharmacists favored substitution at the pharmacy level, provided the physician is informed about it. Patients also favored pharmacy substitution, given that the patient is told. Physicians generally opposed automatic substitution. They wanted to be able to know which product the patient received when a problem arises. The nocebo effect was also a concern. The authors said, “this study found that stakeholders are concerned about mandated switching, as this may result in worse patient-perceived treatment outcomes because of a possible nocebo effect.”

Several regulators, physicians, and pharmacists agreed drugs should be used in a cost-effective manner for the common good. However, physicians also noted the substantial time and effort required to switch a patient from a reference product to its biosimilar may discourage prescription of biosimilars.

Most physicians and nurses and some regulators viewed tangible incentives as appropriate but direct financial benefits as inappropriate. The idea of gainsharing, allocating biosimilar savings toward improving patient care, was embraced by most interviewees as a positive motivator, because “savings could partially serve to improve local clinical care.” Some examples of gainsharing mentioned were financial support for a hospital ward, hiring new staff, or reinvesting biosimilar savings to enhance monitoring of patients.

The investigators concluded with 11 key recommendations derived from their interviews:

Addressing health care professionals’ needs regarding switching and biosimilar use

Communicate about study results and clinical experience on switching.

Express a clear, consistent EU regulatory position on biosimialr interchangeability.

Develop a multistakeholder protocol to guide switching in clinical practice.

Develop tangible and intangible incentives for stakeholders to use biosimilars.

Recommendations regarding switching decisions

Avoid mandatory switching but allow communication between stakeholders.

Recommendations for long-term sustainable competition with a biosimilar presence

Raise awareness about drug prices and societal responsibility to prescribe and use drugs cost-effectively.

Actively and publicly communicate the benefits of biosimilar use.

Share biosimilar uptake and prescribing data “to allow peer-to-peer benchmarking.”

Report the savings allocation from biosimilar use transparently.

Develop policies with a long-term vision beyond short-term cost savings.

Barbier L, Simoens S, Vulto AG, Huys I. European stakeholder learnings regarding biosimilars: part II–improving biosimilar use in clinical practice. 

. Published online October 15, 2020 Oct 15. doi:10.1007/s40259-020-00440-z

European investigators have derived a set of core principals for developing higher utilization of biosimilars. 

Europeans Devise Checklist for Promoting Biosimilar Use

Biocon, which launched an insulin glargine product on the US market in August, reported increased revenue of $238 million for the quarter just ended, driven by 11% growth in biosimilar sales, as well as growth in research services (12%) and generics revenue (8%). The net profit was $23.6 million.

Revenue for the company’s biosimilar products totaled $91.5 million, up from $82.2 million. Biocon has commercialized biosimilar versions of trastuzumab, pegfilgrastim, bevacizumab, and adalimumab in markets around the world. Besides insulin glargine, it also produces rh-insulin.

During the quarter ended September 30, Biocon 

the long-acting insulin glargine product Semglee in partnership with Mylan. Because it was approved by the FDA under the Food Drug and Cosmetic Act and not via the biosimilar pathway established under the Biologics Price Competition and Innovation Act, the agent is not officially considered a biosimilar, although Biocon and Mylan have announced intentions of seeking biosimilar and interchangeable status for the product on the US market. 

Interchangeable status would allow pharmacists to dispense the product as a substitute for the reference product Lantus without the need to obtain clearance from the prescribing physician.

“Our insulin glargine, Semglee, was commercialized in the United States by our partner Mylan during the quarter, thus heralding our entry into the US insulins market,” Biocon Executive Chair Kiran Mazumdar-Shaw said in the earnings 

. “With this launch, we have expanded our portfolio of biosimilars and occupy a position of impactful influence in the biosimilars segment.”

Semglee was launched in Spain over the past quarter. In addition, Mylan and Biocon launched an etanercept biosimilar in Europe, and Biocon aims to establish commercial offices in Brazil, Malaysia, United Arab Emirates, and Saudi Arabia.

Biocon said the quarterly growth in biosimilars revenue was led by its trastuzumab biosimilar (Ogivri), which the company said has a 6% share of the US market for trastuzumab (4% and 10% in the 150- and 420-mg product segments, respectively) and pegfilgrastim (Fulphila), which has a 15% share of the prefilled syringe market in the United States.

“Ogivri continues to be the leading biosimilar trastuzumab in Australia and Canada, and it has a double-digit share in 3 markets in Europe,” Biocon said. “For Semglee…we are witnessing encouraging market penetration in certain markets, such as Slovakia and Croatia.”

Biocon had a busy quarter, which included the launch of a long-acting insulin glargine product (Semglee) in partnership with Mylan.
