A Review of Biosimilars in 2021: Regulatory, Legal Developments, and What’s in Store for the New Year

Another year of biosimilar developments has come and gone, and 2021 proved to be better for the industry compared with 2020, with 4 FDA approvals, 3 US launches, 2 approvals for interchangeable biosimilars, and a number of regulatory and legal developments.

Presenters of a recent webinar said that this progress indicates that the United States is slowly moving away from its focus on COVID-19 treatments toward advancing the biosimilar industry.

The webinar, presented by Fish and Richardson, an intellectual property firm based in Boston, Massachusetts, included a review of how the landscape of biosimilars has evolved over the year as well as prospective looks at what’s to come from John Adkisson, JD, president and CEO of the Fish and Richardson, and Jenny Shmuel, JD, principal at Fish and Richardson.

Federal Regulatory Decisions

Shmuel recapped the long list of regulatory updates from the year, including the FDA’s updated guidance regarding Q&As on biosimilar development and the Purple Book. Additionally, HHS released a report calling for the follow-through of the FDA’s attempts to reform the US patent system to incentivize innovation and prevent the delay of generic and biosimilar drugs.

The FDA also spent a portion of the year considering the citizen’s petition filed by Boehringer Ingelheim in late 2020. The petition requested for the FDA to change its definition of the word “strength” as it is used in the Biologics Price Competition and Innovation Act to be more inclusive to biosimilars that have different volumes of inactive drug contents than the reference product. According to Shmuel, the agency announced in May 2021 that it was unable to reach a decision on the petition.

President Biden signed an executive order in July 2021 intended to improve competition in the US economy by addressing the unfair anticompetitive conduct or agreements in the prescription drug industry as well as other industry. The order specifically mentions the need to address agreements that delay the market entry of generic and biosimilar drugs.

Congress also passed the Advancing Education on Biosimilars Act and proposed 9 pieces of legislation that could improve access and uptake of biosimilars in the United States. Some states, including California, Oregon, Connecticut, Illinois, Minnesota, and New York have proposed legislation to address “pay-for-delay” settlements.

Biosimilar Legal Drama

In 2021, the FDA sent a warning to Amgen over the misleading advertisement of Neulasta (pegfilgrastim) that seemed to make “false or misleading claims and representation about the benefit of” the drug, suggesting that Neulasta may be more effective than biosimilar versions, Shmuel noted.

Additionally, AbbVie and Alvotech are in an ongoing legal battle over the legitimacy of Alvotech’s development of an adalimumab biosimilar (AVT02) referencing AbbVie’s Humira. AbbVie alleged that Alvotech had used stole trade secrets to create their biosimilar. AbbVie was also investigated by Congress regarding whether the company has conducted any anticompetitive practices to keep adalimumab biosimilars from entering the US market.

Looking Ahead

In addition to seeing how the AbbVie/Alvotech litigation and the congressional investigation into Humira practices will play out, Shmuel said a number of ongoing clinical trials could bring new biologics license applications and FDA approvals in 2022. In particular, she mentioned that Amgen is running phase 3 clinical trials for biosimilars referencing Eylea (aflibercept), Stelara (ustekinumab), and Soliris (eculizumab), which are all products that do not have FDA approved biosimilars yet.

Another big question to be answered in 2022 is how the market and clinical settings will react to interchangeable biosimilars. Now that there are 2, Shmuel said that people will start to see how interchangeable biosimilars work in the market, how they’ll impact trends, and how patients and physicians will treat them. Seeing how state laws regarding automatic substitution will play out with these products available will be an important area to watch as well.