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Despite the persistence of the patent thicket, and slow uptake by the medical community, biosimilars are positioned for growth in the US.
Generic small-molecule pharmaceuticals transformed the industry when they were introduced to the United States in the 1980s, slashing costs and making more drugs accessible to more patients. According to IQVIA, they saved the US healthcare system some $313 billion in 2019, and have cut costs by $2.2 trillion since 2009 (1).
Decades later, as the cost of biologics became a larger factor in rising healthcare costs, biosimilars (similar but not chemically equivalent to their name-brand references) were introduced with similar cost-cutting intent. However, their acceptance in the US has been slow. FDA established a pathway for biosimilars approval in 2010, with the Biologics Price Competition and Innovation Act (BPCIA), but it took five years for the agency to approve the first biosimilar. The next few years saw relatively few biosimilar approvals and intense battles over intellectual property, yet IQVIA found, biosimilars still saved the US healthcare system $2.2 billion in 2019 and $4.5 billion in four years (1).
In 2019, a year in which policy experts and former FDA Commissioner Scott Gottlieb (a strong advocate for biosimilars) openly debated whether or not to “throw in the towel” on the whole biosimilars concept, FDA wound up approving 10 new biosimilars (Table). Today, 29 biosimilars have been approved in the US, and IQVIA expects biosimilars to gain $80 billion in sales and generate $100 billion in healthcare cost savings through 2025 (2).
So far, most biosimilars development has focused on oncology; supportive therapies used with other treatments; and anti-inflammatories, but in 2020, under the BPCIA, FDA’s approval pathway changed for 90 reference products, including insulin. Although they aren’t technically called biosimilars, these transitional biologics, originally submitted as new drug approvals (NDAs) under the US Food, Drug, and Cosmetic Act 505 b(2), must now be submitted as biologics licensing applications (BLAs) under the BPCIA 351(k). A number of companies, including Mylan and Biocon, are actively developing therapies in this area.
Improving the outlook for biosimilars has been FDA’s Biosimilars Action Plan, rolled out in 2018 to improve the internal agency review process and encourage innovation. On the legislative side, H.R. 133, which became law at the end of 2020 (3), set requirements designed to prevent delays in biosimilar commercialization. Among other things, it calls for patent data transparency, requiring that patent information and expiration data be published in FDA’s Purple Book, which is now an open-access online database (4).
In 2020, FDA also clarified distinctions between regular biosimilars and interchangeable types (5), which require additional clinical testing but could be used to replace innovator drugs in patient prescriptions without informing the prescribing physician. So far, none of the biosimilars approved by FDA has gained interchangeable status, but developers can now submit applications for interchangeable status only, or two-part applications for both biosimilar and interchangeable status.
Despite all the advances that have been made to help stimulate biosimilar development, hurdles remain. Most significant is the large number of patents that innovators have filed to delay the introduction of biosimilars. Of the 29 biosimilars approved for use by FDA, only 19 can currently be sold. The impact of the name-brand “patent thicket” is particularly evident with adalimumab biosimilars, anti-inflammatory treatments similar to AbbVie’s Humira. In the European Union, eight such biosimilars are available. In the US, six have been approved, but none will be available until 2023 (6), as a result of agreements that each developer reached with AbbVie.
In 2019, a third-party payor representing US labor union members and insurance firms launched a class action anti-trust suit against AbbVie, which had applied for more than 100 manufacturing and formulation patents for Humira years after it had been introduced. The suit alleged that AbbVie and the biosimilars developers had blocked competition. In 2020, however, a judge dismissed the case, which could set a precedent for the future (7).
Clearly, the costs of entry to the biosimilars market are considerable. Amgen has invested more than $2 billion on 10 biosimilar candidates since 2010 (8). However, biosimilars development is starting to pay off for more companies. Pfizer, for example, which had three biosimilars approved in 2019, saw its fourth quarter 2020 biosimilars income increase by 80% from the previous year (9). Increased competition among biosimilars manufacturers, and pressures on innovators to reduce costs, may finally achieve the goals originally envisioned for biosimilars, as they move into their sixth year in the US.
1. Association for Accessible Medicines, “2020 Generic Drugs and Biosimilars Access and Savings in the US,” accessiblemedicines.org, 2020.
2. M. Aitken, M. Kleinrock, E. Muñoz, “Biosimilars in the United States 2020- 2024: Competition, Savings, and Sustainability,” iqvia.com/insights, September 29,2020.
3. US Congress, H.R. 133, The Consolidated Appropriations Act of 2020, congress.gov.
4. FDA, Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability, fda.gov.
5. FDA, Biosimilarity and Interchangeability: Additional Q&As, fda.gov, Nov., 2020.
6. I. Gherghescu, M.Begoña Delgado- Charro, ”The Biosimilars Landscape: An Overview of Regulatory Approvals by EMA and FDA,” Pharmaceutics 13 (01), 2021.
7. R. Gervase, J.Miller et al. “AbbVie’s Enforcement of its ‘Patent Thicket’ for Humira,” mintz.com, June 18, 2020.
8. Amgen, 2020 Biosimilars Trends Report, amgenbiosimilars.com, 2020.
9. T. Hagen, “Pfizer’s Biosimilars Earnings Soar,” CenterforBiosimilars.com, Oct. 27, 2020.
Agnes Shanley is senior editor of BioPharm International.
Vol. 34, No. 3
When referring to this article, please cite it as A. Shanley, “Biosimilars Hit Their Stride,” BioPharm International 34 (3) 2021.