In an interview with The Center for Biosimilars®, Cate Lockhart, PharmD, PhD, MS, executive director of the Biologics and Biosimilars Collective Intelligence Consortium, discusses some of the current barriers to biosimilar adoption in the United States and how the industry is working on overcoming them.

Lockhart explains that the status of biosimilar adoption has changed. There was uncertainty and lack of knowledge about the science when biosimilars were first emerging. Now, the uncertainty has been shifted to concerns regarding reimbursement and management, especially as more biosimilars are approved.

As market competition increases, Lockhart says, reimbursement capabilities and formulary designs become more important, because product stocking in a health system or hospital pharmacy is complicated. Providers may be forced to stock all biosimilars approved for a particular reference product and reimbursement may not apply equally for them.

She mentions that some practitioners have concerns over how benefit design and formulary practices will impact their daily workflow. Lockhart says incentives for payers to use certain products may support the use of biosimilars, especially now that there are multiple alternatives to some reference drugs.

Previously, most biosimilars were under the medical benefit; however, some pharmacy benefit biosimilars have started to emerge, and Lockhart is interested in seeing how these biosimilars will change the landscape. Lockhart expects pharmacy benefit biosimilars to play a more prominent role in the decisions that formulary managers make.

Emerging insulin biosimilars will be some of the first products to go through the pharmacy benefit, and Semglee (insulin glargine) was recently approved as a biosimilar with an interchangeability label. Lockhart explains that interchangeability designations for insulin products add complexity. Although she says it’s too soon to tell whether interchangeability will have a significant impact on adoption of insulin biosimilars, she believes more biosimilar manufacturers will seek interchangeability designations.

Finally, Lockhart dives into the subject of how biosimilars can be leveraged in use management programs, saying health systems should refine their coding and administrative systems to help ensure that programs run as smoothly as possible and that workflow is not disrupted.

Videos

Reimbursement concerns and the uncertainty of how interchangeability will impact biosimilar adoption are hot-button issues in the biosimilar space, Cate Lockhart, PharmD, PhD, MS, explains in this interview.

Cate Lockhart Explores the Evolution of Biosimilar Barriers 

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of October 18, 2021.

Number 5: Hopes that insulin biosimilars can improve access and affordability 

 by Express Scripts’ plan to give preferred formulary status to Semglee, a long-acting insulin that is interchangeable with Lantus.

Number 4: Switching between reference adalimumab (Humira) and its approved biosimilars results in no differences in efficacy, safety, and immunogenicity, investigators in Spain have concluded following a 

Number 3: An additional 1.2 million patients 

 from biosimilars by 2025, according to a specialty pharmacy report by CoverMyMeds, a division of McKesson. The report discusses payer/pharmacy benefit manager consolidation, patient adherence, white bagging, and other issues common to specialty pharma.

, Gary Lyman, MD, MPH, an oncologist and hematologist and public health researcher with the Hutchinson Institute for Cancer Outcomes Research, compares the uptake of biosimilars for cancer care and other conditions and provides insight on how uptake could be improved.

 an interchangeable designation for Boehringer Ingelheim’s adalimumab biosimilar Cyltezo, which was originally approved in August 2017 and is scheduled to go on the market on July 1, 2023.

To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of October 18

Amgen has multiple biosimilars in the marketplace, but also many originator drugs, which puts it on both sides of the scrimmage line. 

That gives the company the perspective that policies and regulations designed to stimulate and advance biosimilar competition could be detrimental to the level of innovative investment, as it would potentially make less funding available for biopharmaceutical companies to invest in new drugs, Jen Norton, a vice president and head of US Value & Access for Amgen, says in this interview with Tony Hagen, senior editor for The Center for Biosimilars®. “Oftentimes when you create special legislation to incentivize a particular category over another category, there can be a series of downstream consequences.”

The occasion was Amgen’s presentation of findings from its 2021 Biosimilar Trends Report at the AMCP Nexus 2021 meeting this week at the Gaylord Rockies in Denver, Colorado. Norton authored the report.

Biosimilar market share gains have been strongest in the oncology space, where biosimilars emerged just in the past few years. “It’s really been impressive to see how biosimilars have taken a major role within our health care ecosystem," she says. 

Some developments ahead may rival or exceed biosimilar accomplishments so far, such as the arrival of adalimumab biosimilars in 2023. Patients will be able to self-administer these, and this expansion of biosimilars into the pharmacy benefit will be a critical, market-changing event, Norton says.

In this interview with The Center for Biosimilars®, Amgen biosimilars expert Jen Norton discusses regulatory and policy incentives, interchangeable biosimilars, and market share gains.  



Amgen Executive Discusses Prominent Biosimilar Trends

Here are the top 5 biosimilar articles for the week of October 11, 2021.

 a bevacizumab biosimilar (Bambevi) from Apobiologix, a division of Apotex, the company said in a statement.

Number 4: Ivo Abraham, PhD, a professor with University of Arizona Health Sciences in the Department of Pharmacy Practice, outlined the 

 and savings potential for granulocyte-colony stimulating factor (G-CSF) biosimilars and Neulasta Onpro (pegfilgrastim).

Number 3: A US District Court in Illinois 

 that although trade secret theft may have occurred over an adalimumab biosimilar candidate, it happened far from the state. With only a very "attenuated" connection, there are no grounds to bring action against Alvotech, the judge stated.

 for Coherus BioSciences' ranibizumab candidate (CHS-201) were presented at the Scientific Meeting of the Retina Society, and the company said equivalence end points were met for an on-body injector version of Udenyca (pegfilgrastim).

 between AbbVie and Alvotech could be a defining victory in the struggle to bring biosimilar versions of adalimumab to market, but a yearlong court process must play out first.

The Top 5 Biosimilar Articles for the Week of October 11

Polpharma Biologics, of Gdańsk, Poland, is a rapidly growing developer and manufacturer of novel biologics and biosimilars for global markets. Recently the company filed a biologics license application with the FDA for a ranibizumab biosimilar candidate (FYB201) referencing Lucentis, the blockbuster ophthalmology agent. This was filed in partnership with Santo Holding (Strüngmann Group), Bioeq.

Polpharma Biologics is also developing a natalizumab biosimilar (PB006), referencing Tysabri, for Crohn disease and multiple sclerosis. The company is partnering with Sandoz on the commercialization of this product. Behind FYB201, the natalizumab biosimilar is the next furthest along in development, having reached the clinical development stage.

The global market is still wide open for ranibizumab and natalizumab biosimilars. The only ranibizumab biosimilar approved by US and EU regulatory authorities is Byooviz, a Samsung Bioepis and Biogen product. There are no natalizumab biosimilars on the US or EU markets currently.

In this interview, Polpharma Biologics executives Alex Moulson, vice president of Development, and Pawel Lewinski, head of Portfolio and Commercial Strategy, speak with Tony Hagen, senior editor of The Center for Biosimilars

, about the company’s product expectations and growth. 

Moulson and Lewinski also discuss the company’s broader pipeline of products, such as a planned vedolizumab biosimilar (PB016), for the treatment of autoimmune disease, and pembrolizumab and nivolumab biosimilar candidates (PB014 and PB015, respectively), both “programmed death” protein inhibitors that lower the tumor cell’s defense system and allow immune cells to attack.

Polpharma Biologics has added 300 employees over the past couple of years, bringing its headcount to 800. The company, with facilities also in Warsaw, Poland, and Utrecht, in the Netherlands, continues to expand with multiple new job openings. The company has changed rapidly since The Center for Biosimilars

The Center for Biosimilars® speaks with Polpharma Biologics executives Alex Moulson, vice president of Development, and Pawel Lewinski, head of Portfolio and Commercial Strategy, about the company's biosimilar pipeline.

Polpharma Biologics Executives Discuss Ranibizumab Biosimilar and Other Product Candidates

Here are the top 5 biosimilar articles for the week of October 4, 2021.

Number 5: Sonia T. Oskouei, PharmD, BCMAS, DPLA, the vice president of Biosimilars at Cardinal Health, discussed the 

 that pharmacists and interchangeability designations can affect biosimilar utilization.

 from 2 studies of patients with inflammatory bowel disease (IBD) who switched from intravenous administration of the infliximab biosimilar Remsima (CT-P13) to subcutaneous administration.

Number 3: Preventing the nocebo effect requires a demonstration of confidence in biosimilars from all health care practitioners, including pharmacists, experts said in a newly published rheumatology treatment 

Number 2: Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, talked about the savings that biosimilars have brought to 

 and how he tackles patient and physician concerns over whether biosimilars work as well as reference products.

Number 1: Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, discussed the group’s 

: Market Review—Biosimilar Medicine Markets.

The Top 5 Biosimilar Articles for the Week of October 4

Here are the top 5 biosimilar articles for the week of September 27, 2021.

Number 5: The first ranibizumab biosimilar (Byooviz) has potential to 

 associated with retinal conditions, but may not be the only new approval for ophthalmology treatment coming, explained Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars for Cardinal Health.

Number 4: Reykjavik, Iceland company Alvotech said the FDA review of its adalimumab candidate is being held up by 

Number 3: The month of September 2021 was 

 of biosimilar news. From regulatory actions to policy initiatives to clinical news, no dust was gathered on the road toward wider biosimilar adoption.

, Amgen discussed marketing achievements; US biosimilar policy, payer, and provider acceptance of these agents; and the outlook for further growth.

Number 1: The Center for Biosimilars® spoke with George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology (AAO), about the FDA’s 

 of Byooviz (ranibizumab), the first biosimilar specifically approved for treatment of eye diseases.

The Top 5 Biosimilar Articles for the Week of September 27

In this second part of a 2-part series, Tony Hagen, senior editor for The Center for Biosimilars

, interviews Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about findings from the group’s recent European survey of biosimilar markets: Market Review—Biosimilar Medicine Markets.

Van den Hoven and Piedade continue the discussion of EU market tenders, or contracts that award exclusive or near-exclusive rights to supply a biologic to a geographic area or health care setting.

They note that for Denmark the awarding of multiple tenders for a biologic type has enabled consistency of supply and provided a level of healthy competition.

They also discuss prevailing trends on initiation of treatment naïve patients on biosimilars and switching policies. Most countries have gained confidence with biosimilars by prescribing them for treatment naïve patients to begin with, and now the norm is closer to switching policies, as studies and experience confirm the equivalence of these products to originators, Piedade says.

The United States offers an interchangeable designation that allows pharmacists to substitute biosimilars at the counter without the intervention of a physician, and in the European Union it would seem that without such a designation pharmacists are free to make biosimilar substitutions also free of the encumbrance of checking with physicians first, but in practice it doesn’t work that way, van den Hoven and Piedade explain.

“There are cases where the pharmacist may need to switch the medicine, but in those cases, they will consult with the physician,” van den Hoven says.

Biosimilars in the European Union have moved into treatment of earlier stages of disease in some countries, and this has been a boon for patients who previously were required to use less optimal medicines first, van den Hoven and Piedade explain. This development has depended in part on growing awareness and understanding of biosimilars through support efforts that differ widely across member state boundaries.

The lessons the European Union has learned about getting biosimilars into circulation could be instructive for the United States as well. “What I can see happening in the US now is that the health insurers are understanding that just because a biosimilar is less expensive doesn’t mean it is going to be prescribed. You actually need what I would call an active policy to support biosimilar use and competition,” van den Hoven says.

Across EU member states, health care systems vary a great deal, but common among those that have been successful with biosimilar adoption is the introduction of benefit sharing, unbiased educational resources, and clear direction, Piedade says.

“These countries have a very clear, very well-defined national goal and roadmap so they know clearly where they want biosimilar uptake to be and how to get there,” he says.

Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, analyze findings from the group's recent survey of European biosimilar markets.

Medicines for Europe Experts Discuss Biosimilar Tenders, Substitution, Part II

Imagine that all 50 states in the United States had different biosimilars policies affecting pricing, usage, availability, promotion, and payer reimbursement. It’s something like that in the European Union, although there are overlapping trends from member member state to member state. 

In this first part of a 2-part series, Tony Hagen, senior editor for The Center for Biosimilars®, interviews Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about findings from the group’s recent European survey of biosimilar markets: Market Review—Biosimilar Medicine Markets.

The report elucidates policy variation and biosimilar penetration across EU markets. The biosimilar dispersal is not uniform, van den Hoven and Piedade explain. In the case of insulin, where competition is strong, biosimilar versions may be left out of the game.

In the United States, biologics producers have freedom to set their own prices, and the amount and type of competition may influence the discounts on biologics that are seen; but in the European Union price regulation is more often the norm, and competition between producers adds another level of discounting that results in the true cost, market by market, van den Hoven and Piedade explain.

The discussion also touches on the practice of reference pricing. In the European Union, drug reimbursement is sometimes pegged to a common value that is established through competition among producers. This is known as reference pricing.

The concern we have is will the losers of those tenders return to the market 3, 4 years down the road? Or will they just give up on the market for that product altogether? There are costs associated with you staying in the market, even if you're not selling. 

However, this practice can lead to unsustainably low prices, van den Hoven and Piedade explain. They provide a few different examples of how producers have been affected, along with recommendations for improvement.

They also provide insight on the pros and cons of the length of the contracts, or tenders, producers receive to supply their biologics to EU markets. Longer tenders provide companies with a stable revenue flow, but these may outlast other producers’ staying power, or willingness to return for the next tender opening and bid to supply their own products.

Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, discuss the group’s recent EU report: Market Review—Biosimilar Medicine Markets. 

Medicines for Europe Experts Discuss EU Market for Biosimilars, Part I

Increasing the use of biosimilar pegfilgrastims can save patients and practices money as COVID-19 cases continue to surge; however, some payers are still preventing providers from utilizing them, according to Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.

How is the resurgence of the pandemic in South Carolina affecting your pegfilgrastim prescribing habits?

We are going to increase use of pegfilgrastim more and more and more. I had a pretty long email chain of a literal argument with one big payer saying that you cannot afford to overlook patient safety at the cost of saving money. And I hate to say this, but a couple of third party pathway companies still have not updated their guidelines, even though NCCN [National Comprehensive Cancer Network], ASCO [American Society for Clinical Oncology], and all the other bodies have recommended that, even for patients who are getting a chemotherapy regimen that carries intermediate risk of neutropenia during the pandemic, they recommend considering use of pegfilgrastim. And, in particular for our area, I think I would look at biosimilar pegfilgrastim, simply because this would be less expensive. But some payers are still giving us a hard time, and what they don't realize is that I'm trying to minimize my workflow interruption and optimize the efficiency. It's just been challenging, but we'll do our best to sustain and see where we go.

As COVID-19 cases continue to rise in many states, Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates, provides insight into how biosimilar pegfilgrastims can help reduce costs; however, not all payers are on board.