Skylar Jeremias

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 May 16, 2022.

Number 5: Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting examined the 

 of biosimilar utilization and the impact of products that have been reclassified as biologics on Medicaid spending.

Number 4: A new bill that would amend the Federal Food, Drug, and Cosmetic Act aims to expand FDA 

 for prescription drugs and medical devices, including biosimilars and generics.

Number 3: Biocon’s total revenue for the fourth quarter of the 2022 fiscal year was up 21% from the same period in the prior year, largely due to 

 in sales for the company’s biosimilar and generic drugs.

 Teva Pharmaceutical’s biosimilar (Ongavia), which references Lucentis (ranibizumab), for the treatment of several ophthalmic conditions.

Number 1: In a pharmacokinetic study, Alvotech’s 

 referencing Stelara was shown to have comparable safety and efficacy to the reference product, according to the company’s preliminary results.

To read all of these articles and more, visit 

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The Top 5 Biosimilar Articles for the Week of May 16

New biosimilars are on the way, as JSR Life Sciences launches its business division (Similis Bio) that will improve efficiency and costs related to biosimilar development and Biocon Biologics signs a contract for commercialization in Malaysia.

JSR Life Sciences announced the launch of its 

, Similis Bio, which will function as a partnering program to work with biopharmaceutical companies to improve efficiency and reduce costs related to biosimilar development.

Similis will be able to supply companies with data to help them make decisions on which biosimilars to develop, accelerate early program development, and reduce costs for conducting analyses.

Additionally, the division will foster codevelopment agreements with companies to develop programs for biosimilars, where partners would receive exclusive right, not an obligation, to purchase multiple programs. JSR designed Similis’ collaboration model so that risks of cancelled programs and extended market analysis timelines were mitigated.

“This model will enable changes in strategy far beyond traditional drug development approaches by centralizing reference product data and expertise under one roof…. Similis brings the broad expertise of JSR Life Sciences companies together to jump-start the development of promising biosimilars. By improving timelines and development costs for drug makers, more biosimilars can be brought to market faster. Ultimately, that means more choice and lower costs for patients,” said Jean-Pierre Wery, chief technology officer at JSR Life Sciences.

Biocon Biologics Sets Sights on Malaysian Insulin Market

, Biocon Biologics’ Malaysian subsidiary (Biocon Sdn Bhd) has been awarded a 3-year tender contract of $90 million for its recombinant human insulin product, Insugen, by the Ministry of Health in Malaysia.

Diabetes affects about 3.9 million adults in Malaysia, and the number of people with type 2 diabetes (T2D) has seen great growth over the past 2 decades, increasing from 8.3% of the population in 1996 to 20% in 2019, nearly half of whom were unaware they had T2D. The diabetes population is expected to grow to over 36 million by 2025, amounting to 31.3% of the population. In 2010 alone, about $600 million was spent on diabetes-related health care in the country, approximately 16% of the total national health care budget. About 420,000 patients with diabetes are treated with recombinant human insulin throughout Malaysia.

“We are pleased to renew our commitment to provide affordable access to our recombinant human insulin for people with diabetes in Malaysia through this new government contract. This will enable us to serve over 400,000 people with diabetes using recombinant human insulin, helping the government in its journey towards equitable access to diabetes care,” said Susheel Umesh, chief commercial officer of emerging marketing at Biocon Biologics.

Biocon Sdn Bhd will manufacture and supply its insulin to its commercialization partner Duopharma Marketing Sdn BhD, a subsidiary of Duopharma Biotech, a leading biopharmaceutical company in Malaysia.

Insugen will be available to patients at all Ministry of Health hospitals, district health offices, and health clinics in the country. The news comes after Biocon Biologics insulin glargine biosimilar (Basalog) was awarded a multiministry contract worth $4.2 million for 2 years in September 2021.

“We have been partnering with the Malaysian government since 2016 and have expanded access to life-saving insulin therapy for patients with diabetes. Since our entry to Malaysia in 2011, prices of human insulin have dropped over 20% and insulinization has also improved by 30%. As the only insulin manufacturer in Malaysia, we have been able to achieve insulin self-sufficiency and improved access while providing savings to our partner – [Ministry of Health], Malaysia,” said Kiran Kumar Gandhirajan, senior vice president and site head at Biocon Std Bhd.

Articles

Eye on Pharma: Similis Bio Launch, Biocon Biologics Sets Sights on Malaysian Biosimilar Market

Altering reimbursement procedures needs to become a bigger priority for government officials to incentivize biosimilar utilization, according to Eric Tichy, PharmD, MBA, vice chair of pharmacy formulary at the Mayo Clinic Health System.

What more should state and federal governments do to ensure that patients have access to biosimilars?

 [that governments should be doing] is making sure the reimbursement incentives are set up the right way where it is actually beneficial for all the different participants to use the biosimilar. The patients themselves, a lot of times they don't see much of a benefit because of the way the benefit design is set up. So, I think making sure the incentives are aligned is very important, and that's one of the areas where you do get some resistance. Making sure the provider, the payer, and the patient all have the incentive to use biosimilars. That's what will make it work really well and increase our access and uptick.

Dr Eric Tichy Calls for Government Officials to Realign Incentives in Favor of Biosimilars

Ongavia, a ranibizumab biosimilar developed by Teva Pharmaceuticals, has received regulatory approval from the United Kingdom for the treatment of several ophthalmic conditions, according to a 

 by the UK Medicines & Healthcare Regulatory Agency for use in patients with vision loss as a result of neovascular age-related macular degeneration (wet AMD), diabetic macular edema, proliferative diabetic retinopathy, macular edema secondary to retinal vein occlusion, or choroidal neovascularization. The United Kingdom is the first European country to approve Ongavia.

“Teva is pleased to bring the first biosimilar for Lucentis in ophthalmology to clinicians and patients in the UK,” Richard Daniell, executive vice president at Teva Europe Commercial, said in a statement. "Our mission is to improve access to advanced treatments at attainable prices and we are establishing a role for biosimilars. We believe that unlocking value in biologics is the new frontier in medicine and lowering system costs around the globe is the key to broadening patient access. We are committed to high-quality products and services to support the ophthalmology community."

Ranibizumab products function by inhibiting vascular endothelial growth factor, which can lead to excessive blood vessel formation in the retina. AMD is the leading cause of blindness in developed countries and is estimated to impact up to 77 million people in Europe by 2050, creating a significant global burden for health care systems and societies.

“With the incidence of wet AMD increasing, it is expected that a considerable amount of healthcare resources and careful planning will be needed for decades to come,” Teva wrote.

In the randomized, double-masked, parallel group, multicenter phase 3 COLUMBUS-AMD study, Ongavia was comparable with the reference product in terms of its clinical efficacy as well as ocular and systemic safety in patients with AMD.

Other companies who are looking to release their own ranibizumab biosimilars include 

The ranibizumab biosimilar created by Samsung Bioepis in partnership with Biogen (Byooviz; ranibizumab-runa) was the first biosimilar to Lucentis to be approved in the 

. Byooviz was also approved in the United Kingdom in 

, making Ongavia the second ranibizumab biosimilar to be approved in the country.

Ongavia was developed in collaboration with BioEq. As part of the partnership, Teva will have exclusive commercialization rights in the United Kingdom, the European Union, and Canada. The biosimilar is under review within the European Commission and submission for Canadian approval is expected to be completed in late 2022.

 in its pipeline, 3 of which are in phase 3 trials and 8 are in preclinical development. In addition to Ongavia, the company’s adalimumab biosimilar referencing Humira is under regulatory review and is a part of a collaboration 

 for commercialization in the United States.

Teva also has a commercialization agreement with Celltrion Healthcare for Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin, and Truxima (rituximab-abbs), a biosimilar to Rituxan. 

 launched in the United States in March 2020 and 

The United Kingdom has approved Teva Pharmaceutical’s biosimilar (Ongavia) that references Lucentis (ranibizumab) for the treatment of several ophthalmic conditions.

Teva’s Lucentis Biosimilar Gains UK Approval

Alvotech shared positive results from its pharmacokinetics similarity study for its ustekinumab biosimilar candidate (AVT04) and the reference product (Stelara).

“We are pleased with the successful outcome of the AVT04 [pharmacokinetics] similarity study and the continued progress of our overall pipeline. We expect the results from our confirmatory efficacy and safety study for AVT04 before the end of the 2nd quarter,” said Joseph McClellan, chief scientific officer at Alvotech, in a company 

The 3-arm, single dose, parallel design phase 1 study (AVT04-GL-101) was conducted to assess the pharmacokinetics, safety, tolerability, and immunogenicity profiles of a 45-mg/0.5-mL subcutaneous dose of the biosimilar compared with Stelara, which is approved for use in the United States and the European Union. There were 294 healthy adult volunteers enrolled from Australia and New Zealand.

Ustekinumab is a humanized immunoglobulin G1k (IgG1k) monoclonal antibody used to treat psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis. IgG1k antibodies bind to the p40 protein subunit utilized by interleukin (IL)-12 and IL-23 cytokines.

, Stelara accounted for over $9.1 billion in total sales, $5.9 billion of which were from the United States.

 are all working on developing their own ustekinumab biosimilars. Formycon recently 

 a deal with ATHOS to acquire assets for its own ustekinumab biosimilar candidate.

In addition to AVT04, Alvotech’s adalimumab biosimilar (

 for both regulatory approval and interchangeability status in the United States. The product, which references Humira, is also approved in Canada and is awaiting launch and has received marketing authorization status from the European Commission.

Other biosimilars that Alvotech is in the process of 

 include an omalizumab candidate (AVT23), a denosumab candidate (AVT03), a golimumab candidate (AVT05), an aflibercept biosimilar (AVT06), and 2  undisclosed molecules (AVT16 and AVT33). AVT23 will reference Xolair, AVT03 will reference Prolia/Xgeva, AVT05 is a biosimilar to Simponi, and AVT06 will reference Eylea.

“We are delighted at the continued progress of our pipeline of biosimilar candidates. This continued progress demonstrates the strength of Alvotech’s purpose-built biosimilar platform,” said Róbert Wessman, founder and chairman at Alvotech.

In a pharmacokinetic study, Alvotech’s ustekinumab biosimilar referencing Stelara was shown to have comparable safety and efficacy to the reference product, according to the company’s preliminary results.

Alvotech Announces Positive Phase 1 Results for Ustekinumab Biosimilar

Pfizer and its subsidiary Hospira were previously involved in a patent dispute over the development and marketing of its biosimilars referencing Neupogen (

), both of which were developed by Amgen and are used to treat patients undergoing chemotherapy who are at risk of developing febrile neutropenia.

According to reports from Bloomberg Law, Amgen settled with Pfizer in 

 for its pegfilgrastim biosimilar. However, Pfizer seems to be taking a page out of Amgen’s handbook by filing a 

 against Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow to stop the marketing of Brenzys, which is a biosimilar referencing Enbrel (etanercept), in Australia.

In the court documents, Pfizer alleged that the respondents infringed Australian Patent No. 2005280034, a patent that covers cell culture methods. Brenzys; also known as SB4, Eticovo, and Benepali depending on the country where the drug is being marketed; was approved for use by Australia’s Therapeutic Good Administration in 2016.

Although reference product manufacturers frequently sue biosimilar manufacturers over patent infringement, often resulting in 

, in which the biosimilar manufacturer is paid by the reference biologic manufacturer to delay entry of the biosimilar to the market, Pfizer is seeking damages from the sales of the biosimilar in Australia and for the barring of future sales of the drug until Pfizer’s patent expires.

Currently, Pfizer shares marketing rights with Amgen over reference etanercept. Amgen is notorious for suing biosimilar manufacturers to delay etanercept competition in the United States, where etanercept biosimilars are barred from entering the market until 2029. There are currently 2 

 etanercept biosimilars, including Eticovo (etanercept-ykro).

In the European Union, Brenzys is marketed as Benepali and was granted marketing authorization in January 2016. There are a total of 3 etanercept biosimilars approved in the European Union.

 in Canada for the treatment of moderate-to-severe rheumatoid arthritis in adults and ankylosing spondylitis. In September 2020, it received expanded indications to include plaque psoriasis, psoriatic arthritis, and juvenile idiopathic arthritis. There are 2 etanercept biosimilars approved in Canada. Brenzys was also approved for marketing in 

After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit against 5 companies over the development of Brenzys, an etanercept biosimilar, in Australia.

Pfizer Settles 2 Lawsuits, Starts Another Over Etanercept Biosimilar in Australia

Julie M. Reed, the executive director of the Biosimilars Forum, discussed how biosimilar savings can differ between stakeholders and the importance of competition for creating those savings.

How do the potential savings related to increased biosimilar utilization differ for health plans and patients?

That's a great question. I think it differs only in who the stakeholder is. The cost savings are there for everyone. Now, what really differs is the responsibility of the health plans. They can and should include all biosimilars on their formularies, and they should cover all biosimilars, and that gives patients and doctors access to all the biosimilars.

That's really key because what we know and our economic studies show is that the more biosimilars competing at the same time with the reference product, you're seeing the prices go down faster, you're seeing greater cost savings. If it's only 1 biosimilar vs all the biosimilars and having equal access and coverage, you're not seeing the robust competition that you could be having. That, in turn, [leads to] the price goes down, the co-pays go down, the prices for patients and everything else.

So, that's a key piece as far as the payers and their formularies, and Medicare, and the governments. They have a responsibility to really promote and increase the uptake to these lower-cost products.

Julie M. Reed, the executive director of the Biosimilars Forum, discusses how biosimilar savings can differ between stakeholders and the importance of competition for creating those savings.

Julie Reed Talks About How Savings Can Differ Between Patients, Health Plans

Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting examined the real-world patterns of biosimilar utilization and the impact of products that have been reclassified as biologics on Medicaid spending.

Real-world Patters of Oncology Biosimilars

Use of biosimilars was found to result in significant cost savings without requiring increased utilization other health care resources, suggesting that they are an ideal alternative to a reference, according to researchers at Intermountain Healthcare and SelectHealth.

Biosimilars offer patients and payers access to lower-cost alternatives to expensive reference products, and more research is needed to show the full financial and clinical impacts of increasing biosimilar utilization.

The researchers collected data on patient claims from SelectHealth, Medicaid, and commercial medial and pharmacy claims for bevacizumab, trastuzumab, and rituximab products between July 1, 2013 and September 21, 2021. In total, 1830 patients had claims for a reference product (Avastin, Herceptin, Rituxan, respectively) and 414 patients had claims for a biosimilar.

Two rituximab biosimilars (Truxima and Ruxience), 3 trastuzumab biosimilars (Ontruzant, Trazimera, and Kanjinti), and 2 bevacizumab biosimilars (Mvasi, Zirabev) were included in the analysis.

Biosimilars for the 3 molecules were found to be statistically significantly cheaper per claim, with cost per claim amounting to approximately $1056 less compared to claims for the reference products. The authors said that this could results in significant cost savings per year for patients and payers.

When claims were divided by the number of patients per product, there were no significant differences observed in supportive care claims between them, suggesting that further investigation into the supportive care space is needed.

Impact of Reclassified Biologic Products on Medicaid Spending

Although the BPCIA’s follow-on pathways were effective at promoting follow-on competition among long-acting insulins, millions more in savings for 

 could have been provided if biologic reclassification was done in 2010 instead of 2020.

Furthermore, if reclassification occurred in 2010, development time, drug patents, and other barriers would likely have delayed competitive biosimilars from entering the market. However, the products may have been able to enter the market before 2021.

The BPCIA is the regulatory work that established the approval pathway for biologics and biosimilars. 

, some products, such as insulins, growth hormones, digestive enzymes, that were approved by the FDA using new drug applications were reclassified as biologics as a way to increase competition.

To understand the current level of market competition, the researchers collected data from the Medicaid State Drug Utilization Data between 1991 and 2021 for all reclassified drugs. Afterwards, they estimated the cost of the 10-year preparation period for long-acting insulin products, essentially providing another 10 years of exclusivity for the reference product (Lantus).

The estimated difference in gross reimbursement from 2010 and 2020 was found to be about $4.5 million in missed savings for Medicaid.

The investigators said that the ultimate impact of the BPCIA is still unknown and the introduction of 

 (insulin glargine), the first biosimilar to receive interchangeability status in the United States, showed promise for additional insulin competition and future interchangeable biologic products.

Semglee entered the market in late 2020 and was automatically priced lower than Lantus and Basaglar. The authors theorized that net costs for insulin glargine could be further reduces as more competitive products like Semglee enter the market.

“Continuing this analysis in 5-10 years will reveal the actual impact of any additional competitors on the reimbursement levels for insulins, growth hormones, enzymes, and other biologic classes,” the investigators said.

Matlock AS, Koch C, Beal A. Real world healthcare costs, utilization, and treatment patterns of biosimilar oncology medication. Presented at: Academy of Managed Care Pharmacy 2022 Annual Meeting; March 29-April 1; Chicago, IL. Poster C15.

Carlson EL, Schondelmeyer SW. Estimating the impact of reclassified biologic products under the Biologics Price Competition and Innovation Act on Medicaid spending. Presented at: Academy of Managed Care Pharmacy 2022 Annual Meeting; March 29-April 1; Chicago, IL. Poster U41.

Conference Posters Highlight Real-world Trends of Biosimilars, Reclassified Biologics

Here are the top 5 biosimilar articles for the week of May 9, 2022.

Number 5: A report on biosimilar uptake and existing policies signaled that policy makers should 

 when establishing new policies to boost biosimilar utilization and savings, as many patients and providers still have concerns on their usage.

Number 4: Biosimilar manufacturers should consider 

 to overcome some of the barriers that prevent biosimilars from entering the market and obtaining market share, according to Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board.

Number 3: Amgen’s earnings report for the first quarter of 2022 revealed that as some of its biosimilars experienced 

, its sales for reference products that are facing biosimilar competition decreased.

Number 2: A Vanderbilt University health policy researcher called for modernization of Medicare policies to 

 out-of-pocket costs for seniors, as more high-cost cancer drugs are managed under the Part D program.

Number 1: During the Coherus Biosciences earnings call, the company announced that it 

 its licensing agreement with Innovent Biologics for Byvasda, a bevacizumab biosimilar candidate referencing Avastin.

The Top 5 Biosimilar Articles for the Week of May 9

 that would amend the Federal Food, Drug, and Cosmetic Act aims to expand FDA user fee programs for prescription drugs and medical devices, including biosimilars and generics.

HR 7667, also known as the Biosimilar User Fee Amendments of 2022, was 

 by Representative Anna Eshoo (D-California) and Health Subcommittee Ranking Member Brett Guthrie (R-Kentucky). It was been referred to the House Committee on Energy and Commerce. According to 

, the committee voted 30-0 to advance the measure.

“This legislation would reauthorize FDA’s user fee programs, which are critically important to ensure the agency has the funding it needs so that Americans can continue to trust that the drugs and medical devices they use are safe and effective…. This comprehensive package also includes important provisions that will help lower drug costs for the American people by promoting competition,” said Energy and Commerce Committee Chairman Frank Pallone, Jr (D-New Jersey) during his 

 at a Health Subcommittee markup of 6 bipartisan bills, including HR 7667.

User fee programs for biosimilars, as monitored under the Biosimilar User Fee Act, are used to support the 

review of biosimilar product applications

, including hiring staff, improving systems, and maintaining a well-managed program to optimize patient access to these medications. User fees are collected from applications and the FDA is responsible with ensuring that they are sufficient to cover expenses.

When the COVID-19 pandemic hit, the FDA was looking to revise its methodology for determining the needs for its human drug and biosimilar biologic review programs. A major problem with these programs was that unexpected workload increases did not result in comparable increased in user fees collected from manufacturers who submitted applications for new drugs to be reviewed, leading to the FDA experiencing a 

“The Food and Drug Administration’s user fee agreements allow the agency to fulfill its mission to review and approve the medications that Americans rely on…. As we continue to face the COVID-19 pandemic, adequate funding and staffing levels at FDA are more important than ever. Patients rely on FDA’s gold standard of safety and efficacy, and the American people are relying on us to ensure the agency has the resources it needs to improve development, review applications, and monitor drug safety in a timely manner,” said Eshoo in a 

A new bill that would amend the Federal Food, Drug, and Cosmetic Act aims to expand FDA user fee programs for prescription drugs and medical devices, including biosimilars and generics.