A 2021 Recap of Biosimilars: Approvals, Legislation, and What’s to Come

After a slow 2020 for biosimilars, 2021 picked up the pace a bit, with more approvals, some updated guidance, new potential legislation, and greater uptake for marketed products, suggesting that the United States is shifting focus from pushing COVID-19 treatments back to growing the biosimilars industry, speakers in a recent webinar concluded.

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.

4 FDA Approvals and 3 Launches

According to Shmuel, throughout 2021, there were 4 FDA approvals, including Semglee (insulin glargine-yfgn) in July, Byooviz (ranibizumab-nuna) in September, and Rezvoglar (insulin glargine-aglr) in December. Semglee and Rezvoglar reference Lantus and Byoozviz is a biosimilar for Lucentis. Yusimry (adalimumab-aqvh), a biosimilar referencing Humira, was also approved at the end of December 2021.

There were also 3 biosimilars launched on the US market, including Riabni (rituximab), Nyvepria (pegfilgrastim), and Semglee. Riabni is a biosimilar referencing Rituxan and Nyvepria is a biosimilar for Neulasta.

Compared with 2020, there were more FDA approvals (4 vs 3) but there were less biosimilar launches in the United States (3 vs 5).

2 Interchangeable Biosimilars

Shmuel noted a major milestone in 2021 was the approvals of 2 interchangeable biosimilars: Semglee and Cyltezo (adalimumab). Semglee was already on the market when the drug received an interchangeable designation and had to be launched a second time with a new interchangeable label.

Additionally, Cyltezo is the first adalimumab biosimilar to receive an interchangeable designation and given that the biosimilars for Humira will begin entering the market in 2023, Cyltezo will be a real test to seeing how interchangeability impacts biosimilar adoption, according to Shmuel.

Federal Regulatory Decisions

Shmuel recapped some of the 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.

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.

Looking Ahead

Shmuel previewed the year ahead for 2022. Currently there are some applications pending, but 3 biosimilars for Eylea (aflibercept), Stelara (ustekinumab), and Soliris (eculizumab) are in phase 3 clinical trials, suggesting that they could be the next ones to come down the pipeline.

Another big question to be answered in 2022 is how the market and clinical settings will react to interchangeable biosimilars. Now that we have 2 approved and 1 on the market, Shmuel said 2022 will act as the start of seeing how much market share interchangeable biosimilars will gain, how they’ll impact trends, and how patients and physicians will respond to them. Seeing how state laws regarding automatic substitution will play out with these products available will be an important area to watch as well.