Tony Hagen is senior managing editor for The Center for Biosimilars

Articles

The wearable injector has a failure rate that adds hospitalization costs; therefore, biosimilar pegfilgrastim may hold cost advantages, investigators conclude. 

Investigators: Biosimilar Pegfilgrastim Has Advantages Over Wearable Injector

The Songdo district of Incheon, Republic of Korea, is rapidly becoming a major biopharmaceuticals production center. 

Celltrion Relies on Domestic Construction Amid the Pandemic

In November, the Supreme Court heard arguments on the Affordable Care Act, Europe fired up its efforts to create a more biosimilar-friendly environment, and Genentech fought to protect its bevacizumab franchise.

Biosimilar Legal Roundup: November 2020

The merger of Pfizer's Upjohn division and Mylan has created a biosimilars powerhouse with global reach. 

Newly Created Viatris Joins the Biosimilars Forum

Biosimilar suffixes were intended to help with pharmacovigilance, but they are not widely understood. 

Poll: How Much Do You Know About Biosimilar Suffixes?

The Biosimilars Forum, a group formulated by major biosimilars companies to promote the use of biosimilars, has 

 Meaghan Rose Smith as its first executive director; she takes over at a time when soaring costs of biopharmaceuticals are under particular scrutiny and biosimilars face tough legal obstacles to gaining market traction.

Smith has Democratic connections and could be instrumental with the group’s efforts to promote biosimilars during the Biden administration. She was previously senior advisor and director of communications for HHS during the time the Obama administration worked on the Affordable Care Act (ACA), and previously she worked for Senator Brian Schatz, D-Hawaii, who currently sits on the Senate Committee on Appropriations.

“This is a critical time for the industry, and her extensive health care policy experience in both the private and public sector will be invaluable as we work to realize the significant cost-savings potential of biosimilars and face potential challenges to the BPCIA [Biologics Price Competition and Innovation Act],” said Juliana Reed, president of the Biosimilars Forum and vice president and global corporate affairs lead for Immunology, Inflammation, and Biosimilars at Pfizer. 

The BPCIA, the pathway for biosimilar FDA approval, is a subsection of the ACA, which is under review for constitutional acceptability by the Supreme Court. Although a negative ruling striking down the ACA 

, it remains an outside possibility, according to legal experts.

“Biosimilars are key to lowering health care costs and can save the United States billions of dollars” said Smith. “Now more than ever, as we’re dealing with the devastating impact of the coronavirus pandemic and the Supreme Court considers the BPCIA with the ACA, the future of biosimilars is critical for patients and our country.”

Most recently, Smith headed health care strategies and coalition-building efforts at the public affairs firm SKDKnickerbocker in Washington, DC.

The Biosimilars Forum includes Biogen, Boehringer Ingelheim, Coherus BioSciences, Fresenius Kabi SwissBioSim, Merck and Co, Pfizer, Samsung Bioepis, Sandoz, and Teva.

Meaghan Rose Smith's appointment comes during a time of challenges for the biologics industry.

Biosimilars Forum Chooses Director With Democratic Influence

The European Commission (EC) has approved a Pfizer biosimilar for pegfilgrastim (Nyvepria), paving the way for marketing to begin. The drug is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients who have received chemotherapy treatment. The company said marketing is expected to begin in the first quarter of 2021. 

The addition of Nyvepria will make 8 biosimilar pegfilgrastims available in the EU market vs 4 in the United States. Nyvepria received 

 for marketing in June of 2020. Febrile neutropenia is a common adverse event associated with cancer treatments and leaves patients vulnerable to infections, Pfizer explained in a statement about the EC approval.

“The development of febrile neutropenia in people living with cancer who are undergoing chemotherapy can be a very serious complication,” said Paul Cornes, MD, an oncologist and member of the continuing medical education program of the European Association of Hospital Pharmacists and core lecturer for the European School of Oncology. “The EC approval of Nyvepria provides clinicians with an alternative long-acting option that can help prevent infections.”

Pfizer said Nyvepria, the company’s sixth approved oncology biosimilar and third approved supportive care biosimilar in Europe, was approved following submission of comprehensive data package and on the basis of “totality of evidence” that demonstrated equivalence to the reference drug pegfilgrastim.

The reference product for pegfilgrastim is Amgen’s Neulasta, and this was separately approved by the FDA and the EC in 2002. Pegfilgrastim biosimilars began to appear on the European market in 2018, and there is now a crowded market for these products—in addition to Nyvepria, there are 7 pegfilgrastim biosimilars available for sale in Europe: Fulphila (2018, Mylan), Pelgraz (2018, Accord Healthcare), Pelmeg (2018, Cinfa Biotech), Udenyca (2018, Coherus), Ziextenzo (2018, Sandoz), Grasustek (2019, Juta Pharma), and Pegfilgrastim Multipharma (2019, Multipharma Biologics).

 early this year described pegfilgrastim biosimilars as having achieved a 42% market share in Europe vs 29% in the United States, where Neulasta competes alongside Ziextenzo, Udenyca, Fulphia, and Nyvepria.

However, Amgen’s patented Neulasta Onpro wearable injector device for Neulasta has taken an increasing share of the market from biosimilar versions, which must be administered inside the clinic; and providers and industry observers say the convenience of Onpro for treatment of patients during the pandemic, when office visits have declined, has contributed to the growing use of this product. Neulasta Onpro had a 

 of the US market for pegfilgrastim during the third quarter of 2020. Onpro was 

Pfizer aims to begin marketing Nyvepria in the European Union in the first quarter of 2021.

European Commission Approves Pfizer's Pegfilgrastim Biosimilar

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.

The American College of Rheumatology’s (ACR) Convergence 2020 was the annual meeting of the ACR. This year, due to the pandemic, the meeting was hosted virtually from November 5 to 9. During the conference, a number of study findings were presented on biosimilars used to treat rheumatic diseases. Here are the top 5 biosimilar articles from ACR Convergence 2020.

Number 5: One study of multiple biosimilar switches for patients with a variety of rheumatic musculoskeletal diseases demonstrated a 

 and no major changes in disease activity or function.

Number 4: In a study of the use of infliximab biosimilars among patients with gastrointestinal and rheumatologic conditions, investigators found 

Number 3: Investigators presented evidence of what they say are 

 of a multibiomarker disease activity score in patients with rheumatoid arthritis.

, including one on application methods for Celltrion’s adalimumab biosimilar candidate (CT-P17), were reported at the ACR Convergence 2020.

 at the meeting shed light on performance of Pfizer’s and Celltrion’s versions of adalimumab biosimilars.

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles from the American College of Rheumatology (ACR) Convergence 2020.

The Top 5 Articles from ACR Convergence 2020

Bincy P. Abraham, MD, MS, AGAF, FACG, is a professor of Clinical Medicine at Houston Methodist Academic Institute. She is also the distinguished professor and director of the Fondren Inflammatory Bowel Disease Program at the Underwood Center for Digestive Disorders and director of Gastroenterology Fellowship Program at Houston Methodist Hospital.

In the United States, although the first biosimilar obtained approval from the FDA in 2015, these drugs have been slow to gain support and implementation in clinical practice. Biosimilars of several anti–tumor necrosis factor (TNF) agents have been approved. Currently, 3 infliximab biosimilars are available for the treatment of inflammatory bowel disease (IBD).

Although the infliximab biosimilars are approved for the same indications as the reference infliximab, research shows that many gastroenterologists are still reluctant to use infliximab biosimilars for Crohn disease (CD) or ulcerative colitis (UC).

 Perhaps the most common reason is that insurance coverage for biosimilars has not been widely available, making it difficult to prescribe or switch them. However, even when biosimilars are covered, providers may still hesitate to use these agents. They may not know about biosimilars or their safety and efficacy, or they may lack clinical experience in using them.

A biosimilar is a biological product that is highly similar to and has no clinically meaningful difference from an existing FDA-approved reference product.

 In order to understand biosimilars, one must understand the “totality of evidence” approach, which forms the foundation of biosimilar development programs. In the early stages of biosimilar development, extensive, rigorous studies are conducted to demonstrate structural and functional similarity between the reference biologic and biosimilar. Once this similarity is established, clinical studies are conducted in one or more sensitive populations to “confirm” equivalent efficacy and safety.

 Biosimilars undergo a thorough regulatory review process, and biosimilars approved by the FDA can be regarded as safe and effective for use based on robust scientific evidence.

Are Biosimilars Safe for Patients With IBD?

Biosimilars were introduced earlier in Europe than in the United States, and they have been used without major safety issues for more than 10 years. Several real-world studies conducted in Europe demonstrate the safety of switching from reference infliximab to biosimilars, or from one biosimilar to another biosimilar in the IBD population. One long-term observational, prospective cohort study conducted in Germany showed that switching 148 patients with IBD (96 with CD, 52 with UC) from reference infliximab to a biosimilar did not lead to any increase in disease activity.

 In another prospective, single-center observational study conducted with 221 patients (179 with CD, 42 with UC), there was no adverse effect on IBD control or drug levels after the first or second switch.

In the United States, real-world evidence on biosimilars for patients with IBD has been rather limited, but the data are growing with increasing use of biosimilars. Recently, at the American College of Gastroenterology (ACG) 2020 Virtual Annual Scientific Meeting, held from October 26 to 28, 2020, real-world data on US veteran patients with IBD revealed that a single switch from reference to biosimilar infliximab, or a double switch from the reference product to a biosimilar to another biosimilar, did not lead to any significant safety issues.

 Patients who were stable on the original infliximab medication for at least 3 months were eligible for the study, and they continued to remain stable after switching.

In another real-world study conducted by Cleveland Clinic, patients were randomized to switch to infliximab biosimilar or continue on reference infliximab. The study demonstrated that there was no significant difference in the use of corticosteroid taper, maintenance of remission rates, fecal calprotectin levels, infliximab concentrations, or antibody levels between these 2 groups.

 Since data are limited on multiple switching of biosimilars to reference product or from one biosimilar to another, this information would be important for the FDA to authorize interchangeable status for a biosimilar, which would allow pharmacists to independently substitute biosimilars when dispensing. No biosimilars have that designation to date.

How Does COVID-19 Affect the Use of Biosimilars?

Use of biosimilars can help drive down overall health care costs. Especially now, as the United States continues to battle the coronavirus disease 2019 (COVID-19) pandemic, there will be an increasing burden on the health care system to finance budgets and find savings to ease some of that burden for patients, providers, payers, and employers. Development of new vaccines and treatments for COVID-19 requires billions of dollars of funding from both private and public sources. And trillions of dollars are needed to support hospitals and health care providers for costs and expenses associated with COVID-19. This is an enormous strain on the health care budget, but there is room to drive down the cost of existing medicines through wider adoption of biosimilars.

Also, as patents expire on some biologic molecules in the next few years, there will be more biosimilars available for a wider spectrum of therapies in the market. For adalimumab, 6 biosimilars have FDA approval to enter the US market in 2023 and more are anticipated.

 Will rheumatologists, gastroenterologists, and dermatologists in the United States be ready to use biosimilars by then?

It will be interesting to see how biosimilars change the daily practice of IBD treatment in the coming years. With approximately 3 million Americans living with IBD, and the burden and prevalence of IBD continuing to increase,

 it’s time to embrace the change and think with a holistic point of view. Biosimilars, as treatment options with lower cost than reference products but with the same efficacy and safety, can be the optimal solution to maintain quality care for patients while reducing the cost burden on the health care system in the United States.

1. Park SH, Park JC, Lukas M, Kolar M, Loftus EV. Biosimilars: concept, current status, and future perspectives in inflammatory bowel diseases. 

. 2020;18(1):34-44. doi:10.5217/ir.2019.09147

2. FDA. Biosimilar and interchangeable products. Updated October 23, 2017. Accessed October 2020. 

https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products

3. FDA. Biosimilar development, review, and approval. Updated October 20, 2017. Accessed October 2020. 

https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval

4. Fischer S, Mesfin S, Klenske E, et al. P548 Efficacy, safety, and pharmacokinetics after switching from infliximab originator to biosimilar SB2 in inflammatory bowel disease patients: A long-term observational, prospective cohort study. 

2020;14(Suppl 1):S466-S467. doi:10.1093/ecco-jcc/jjz203.676

5. Luber R, O’Neill R, Singh S, Arkir Z, Irving P. P485 Switching infliximab biosimilar: no adverse impact on inflammatory bowel disease control or drug levels with the first or second switch. 

6. Pernes T, Patel M, Khan N. The safety of switching from originator infliximab or CT-P13 to SB2 among a nationwide cohort of inflammatory bowel disease patients. Presented at: ACG 2020 Virtual; October 23-28, 2020. Poster 1597.

7. Padival R, Heis F, Lee JA, et al. Real world comparison of originator infliximab versus the biosimilar infliximab-abda in the treatment of inflammatory bowel disease. Presented at: ACG 2020 Virtual; October 23-28, 2020. Poster 1625.

8. Davio K. FDA approves Pfizer’s adalimumab biosimilar, Abrilada. The Center for Biosimilars

. Published November 16, 2019. Accessed October 2020. 

https://www.centerforbiosimilars.com/view/fda-approves-pfizers-adalimumab-biosimilar-abrilada

9. Centers for Disease Control and Prevention. Inflammatory Bowel Disease Data and Statistics. Updated August 11, 2020. Accessed October 2020. 

https://www.cdc.gov/ibd/data-statistics.htm

Bincy P. Abraham, MD, explains that even when payers allow coverage for biosimilars, providers may still be hesitant to use them. 

Opinion: Embrace the Era of Next-Generation Biologics

 name suffixes are intended to aid in tracking these medicines and improve ability among health care providers to distinguish between these and other medicines; however, a study indicates that providers and health care administrators may struggle to find utility in these 4-letter appellations.

Biosimilar suffixes take the form of random jumbles of letters—deliberately devoid of meaning—such as “awwb,” which is tacked onto the end of the Amgen version of bevacizumab (bevacizumab-awwb, Mvasi). In a study presented at the American College of Rheumatology (ACR) Convergence 2020, investigators set out to evaluate how much providers and administrators know about biosimilars and whether they perceive the 

 as adding utility and reliability to the prescribing process.

Investigators said they found great variation in how well those surveyed understood basic concepts about biosimilars and a lack of appreciation for the suffix naming convention. “These survey findings suggest a knowledge gap with regard to biosimilars and lack of consensus about the usefulness of employing the 4-letter character suffix in clinical practice,” the authors wrote.

The survey included 83 prescribers and health care administrators such as pharmacists, nurses, and medical coders, an 18% response rate. Surveys were sent to individuals at the University of Pennsylvania Health System and the Corporal Michael J. Crescenz Veterans Affairs Medical Center, both in the Philadelphia area. Providers received a survey if they had previously prescribed a biosimilar.

Investigators said the general knowledge of biosimilars was “rather poor.” Just 52% (28) of respondents were able to answer correctly whether a biosimilar differed from a generic medicine (it does). And although suffixes are intended to help improve pharmacovigilance, 67% of respondents indicated that they used the brand name of the biosimilar in clinical practice to distinguish between biosimilars and their reference products. “Only a minority of respondents [27%] reported regular use of the 4-letter suffix to identify biologic therapies,” the authors wrote.

According to the findings, 85% overall said they find it easier to remember the brand name of a biosimilar than its nonproprietary name and suffix.

Among prescribers, 77% (51) answered correctly that a biosimilar has comparable efficacy, safety, and immunogenicity compared with an originator product. Among administrators, 94% (16) got the question right.

The survey results indicated 42% (28) of providers answered correctly that biosimilars are not generics, vs 88% (15) of administrators. And when it comes to knowing that, by regulatory standard, biosimilars must have the same (“exact”) amino acid sequence as the originator product, 32% (21) and 29% (5) of prescribers and administrators, respectively, answered correctly.

Investigators said 52% (34) of prescribers and 53% (9) of administrators answered correctly that there is variation between manufactured product batches whether they are originators or biosimilars.

“We hypothesize that lack of overall familiarity with biosimilars may have contributed to less comfort with the naming convention,” investigators wrote.

According to the survey, 32% of providers said they feel that the use of brand names for biosimilars introduces commercial bias in clinical decisions. And 21% of providers said the 4-letter suffix induces patients to believe there are “important differences” between biosimilars and originator products. Investigators said 32% of prescribers and 57% of administrators responded that suffixes cause inefficiencies because they conflict with other naming systems.

Of responders who said they were “still in training,” 27 (93%) were residents or fellows.

by Nancy Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs, examines some of the issues behind biosimilar suffixes.

Lavery C, Olave M, Leonard C, et al. Knowledge of biosimilars and perceptions of biosimilar naming conventions in clinical practice. Presented at: ACR Convergence 2020; November 5-9, 2020. Abstract 1605.

The FDA naming convention and its utility are not well understood, and “poor” biosimilar knowledge may be partly to blame, investigators report.

Survey: Providers, Admins Struggle to Appreciate Biosimilar Suffixes

Alvotech of Reykjavik, Iceland, said its adalimumab biosimilar candidate (AVT02) has been 

 for regulatory review by the FDA and the European Medicines Agency (EMA).

The drug references AbbVie’s top-selling Humira for the treatment of arthritis, psoriasis, ankylosing spondylitis, Crohn disease, and ulcerative colitis. The product candidate submitted for review is a high-concentration, 100-mg/mL dose form that matches the newest formulation of Humira, Alvotech said.

An FDA decision on the biologics license application is expected in September 2021, while the EMA decision whether to issue marketing authorization for AVT02 is anticipated in the fourth quarter of 2021, Alvotech said.

“The filings were based on the results of a comprehensive development program and data package comprising of a totality of evidence demonstrating a high degree of similarity of AVT02 compared to its reference product,” said Joseph E. McClellan, PhD, MBA, company chief scientific officer.

The pharmacokinetic (PK) study AVT02-GL-101 successfully established PK similarity between AVT02 and the reference product following subcutaneous administration of a single dose of 40 mg in healthy individuals, Alvotech said.

A second, comparative clinical efficacy and safety trial demonstrated therapeutic equivalence in patients with severe chronic psoriasis. Alvotech said safety, efficacy, tolerability, and immunogenicity profiles were similar.

“The comprehensive AVT02 development program has demonstrated key results comparatively to the reference product, and we are extremely happy to have met our primary objectives in regard to efficacy, safety, and PK similarities,” said Kimber Poffenberger, PhD, senior vice president and global head of Regulatory Affairs for Alvotech.

For recent news about Alvotech’s commercialization partnerships for the global marketing of its biosimilar candidates, click 

The rheumatology and gastroenterology biosimilar candidate would enter the lucrative market established by Humira.

Alvotech Files for US and EU Approval of Adalimumab Biosimilar

Samsung Biologics has decided to abandon efforts to develop SAIT101, a rituximab biosimilar for the treatment of follicular lymphoma, according to a report in the 

The report cited a corporate financial disclosure and official statement this week that stated Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly owned subsidiary, Archigen Biotech, which was solely engaged in development of the rituximab candidate. Samsung Biologics said the subsidiary would be dissolved.

There was a conflict of interest in that a member of the Samsung Group, Samsung Bioepis, was in business collaboration with Biogen, the original developer of Rituxan, the reference brand of rituximab, the report said.

The report estimated that Samsung Biologics had invested $126 million in Archigen Biotech since its founding in 2016. A global phase 3 trial of SAIT101 in patients with follicular lymphoma was completed in August 2020 and demonstrated similar therapeutic effects to the reference product, with an objective response rate of 66.3% vs 70.6% for the Republic of Korea–marketed version of rituximab, MabThera.

Phase 1 trial results of the biosimilar candidate vs MabThera in patients with rheumatoid arthritis demonstrated therapeutic equivalence.

Their rituximab biosimilar candidate was advancing in clinical trials for equivalence but represented a business conflict.

Samsung Biologics and AstraZeneca Dissolve Rituximab Partnership

Here are the top 5 biosimilar articles for the week of November 16, 2020.

 to bring 5 biosimilars to treat oncology and autoimmune diseases to South Africa.

Number 4: US rheumatologists who prescribe tumor necrosis factor (TNF) inhibitors are familiar with biosimilars; however, there is broad awareness only of infliximab biosimilars, according to 

Number 3: The International Generic and Biosimilar Medicines Association (IGBA) has 

 Global Biosimilars Week, an attempt to build momentum for the use of biosimilars.

Number 2: In Europe, the pandemic has revealed problems within health care systems and the need to increase access to biosimilars and reform health care policies, according to a presentation at the Terrapinn Festival of Biologics Basel 2020.

of Samsung Bioepis’ proposed ranibizumab biosimilar (SB11) show that primary end points were met for best corrected visual acuity and central subfield thickness.

The Top 5 Biosimilar Articles for the Week of November 16

Two biosimilars were approved by the FDA in mid-2020, well down from the total of 10 approved last year, but this drop-off does not give a true account of the federal government’s commitment to expanding biosimilar options for patients, according to 

, JD, MBA, formerly a senior advisor to HHS and principal deputy director of the Center for Medicare at CMS.

At the Association for Accessible Medicines 2020 GRx+Biosims conference, Brooks, currently a consultant with South Capitol, discussed the federal policy and regulatory infrastructure for biosimilars that has been constructed over the past few years and pending changes that could pick up the pace of biosimilar adoption.

“Regardless of administration, regardless of party, everybody agrees that encouraging biosimilar uptake, encouraging more competition, is the direction we should be headed. That’s for a pretty obvious reason,” he said giving the oft-cited statistic that biologics, costly by nature, now represent 3% of prescriptions written and 40% or more of total drug costs. “Everyone agrees that the biosimilar market is critical to making sure patients are adequately cared for and we get a good return on our health care investment.”

Politicians may be prodded by public sentiment to beef up biosimilar adoption, but the commitment to getting this done extends deep into the professional ranks of the FDA, CMS, and other federal departments, Brooks said. Such consensus led to the FDA’s Biosimilar Action Plan in July 2018, which was supported by President Donald Trump’s drug price reduction “blueprint,” issued in May 2018.

“Encouraging biosimilar competition was one of the primary planks identified as important for reducing costs and improving quality,” he said. “We saw a lot of actions from both the FDA/regulatory side in terms of governing the supply of biosimilars coming into the marketplace, as well as on the CMS side in terms of how we reimburse.”

for the interchangeable biosimilar pathway. This would take the doctor decision out of whether biosimilars or originator drugs are issued at the pharmacy counter. Interchangeability qualification is a stringent pathway for these agents and that’s because the FDA is very concerned about maintaining safety standards, Brooks said. But there are companies that are moving insulins through the pipeline, which could be the first interchangeable biosimilars, supported by recent FDA “patch” guidance that facilitates the process. This included modification of the requirements for immunogenicity studies leading to biosimilar approval. Interchangeable insulins could become a reality within a 24- or 36-month timeframe, “which would be a tremendous win for a lot of patients as well as for our overall health care system,” he said.

An example of a building block that levels the playing field for biosimilars is the 

, which was signed into law in December 2019 and targeted anticompetitive practices that make it difficult for biosimilar companies to obtain reference product samples they need for development of biosimilars.

Revisions to guidance on naming biosimilars (March 2019) have relaxed but not eliminated requirements for 4-letter random suffixes on biosimilar names, which critics say differentiate biosimilars from reference products in patients’ minds and make it harder for these drugs to achieve acceptance. “That guidance does not come as far as some stakeholders in the industry would like, but the FDA has also engaged in a pretty comprehensive education campaign to reassure people around the safety of biosimilars,” Brooks said. “As we saw with generics, where it took 5, 10, 15 years to get everybody on board with assurances around the safety of those products, there’ll be a journey here.”

On the payment side, CMS has assigned separate codes for each biosimilar “so that each company entering the biosimilar space can control a little bit more of their destiny in terms of what their [average sales price] is going to look like, what their pricing strategy is going to be,” he said.

Proposed changes to Medicare Part D would lower cost sharing for patients who use drugs on a 

designed to incentivize manufacturers to compete to get their drugs on this tier by offering lower prices. “It hasn’t been finalized yet; we’re still anxiously keeping our eyes on the Federal Register to see if CMS will finalize that policy—hopefully, sometime this fall—but it is a particularly good step forward, and it’s also an indication of how the agency is looking at this issue. They see biosimilars as a really important tool in terms of improving the cost piece,” Brooks said.

This tier might also encourage more biosimilar developers to enter the market, thereby enhancing competition, he said.

Several further ideas under consideration at CMS also could make a difference, Brooks said. One is the creation of a demonstration model for shared savings from biosimilars, under which providers would be “nudged” to use biosimilars in place of reference products because of the additional revenue they might earn.

He also expressed faith in the potential value of a Star Ratings system of measures that would grade Medicare Advantage plans on their biosimilar uptake and incentivize a greater shift in that direction. “There are a lot of exciting policy ideas out there. This an extremely dynamic marketplace,” Brooks concluded.

Prior to the turmoil of the pandemic, the FDA and CMS were at work on shoring up the biosimilars market, and this work continues on various fronts, a regulatory/policy expert explains.

Fed Expert Describes Improving Regulatory, Policy Structure for Biosimilars

Celltrion Healthcare has unveiled plans to build a $453.3 million biopharmaceutical plant and research center near its base of operations in Incheon, Republic of Korea. The company said the buildout is supported by rapidly increasing biopharmaceutical demand across the globe.

The biosimilar developer aims to build a 60,000-liter biopharmaceutical plant for diverse types of production needs and also a research center employing 2000 professional biodevelopment personnel for high-level activities related to expanding the company’s pipeline of medicines, including biosimilars, according to a 

. The plans were announced during a biopharmaceutical industry forum this week in Korea.

Celltrion aims to complete the research center and the factory by July 2022 and May 2023, respectively, with the factory starting operations by June 2024. The additional plant will give Celltrion a total production capacity of 250,000 liters annually, up from 190,000 at its 2 existing plants.

Eight 7500-liter incubators will shorten the time between manufacture of drug batches, the company said. A fourth plant also is in the planning stages, although further details were not provided, according to the press report.

 plans for $2 billion in spending on what it called the world's largest factory and biopharmaceutical production center, also in Incheon. The company aims to begin production at the site by the second half of 2022. 

Plans for a $453.3 million high volume plant and research center were unveiled during an industry forum this week in Republic of Korea.