FDA 2021 Biosimilar Approvals: Not Many, Many Firsts

The number of biosimilar approvals in the U.

In recent years, biosimilars have received increasing attention in the United States due to multi-source competition for certain key products and the development of therapeutic areas such as oncology

First Interchangeable Biosimilar - Semglee Insulin Glargine

In July 2021, the FDA approved an interchangeable biosimilar, Viatris (formerly Mylan)'s Semglee (insulin glargine-yfgn)

To meet the additional criterion of interchangeability, the product must not only be considered similar to the reference brand biological product, but must also demonstrate that it "produces the same clinical outcome as the reference product in any given patient

While the industry remains divided to some extent on the desirability and necessity of interchangeability as a separate standard for biosimilars, the designation provides a pharmacy-grade alternative to applicants for interchangeability approval.

Viatris' Semglee hit the market in November after receiving interchangeability approval in July

The first adalimumab interchangeable biologic—Cyltezo

The FDA approved the first adalimumab interchangeable biosimilar, Boehringer Ingelheim (BI)'s Cyltezo (adalimumab-adbm), in October 2021, for the treatment of certain inflammatory diseases

Cyltezo was initially approved by the FDA in August 2017, and under a series of settlements between BI and AbbVie, the drug is not expected to be available in the U.

How interchangeability will affect the broader biosimilar market, especially the biosimilar Humira market, remains to be seen

The first ophthalmic biosimilar

Another U.

Samsung Bioepis said Byooviz will be available in the U.

Additionally, the FDA approved two biosimilars in December 2021, bringing the total number of biosimilar approvals this year to four