US Biosimilar Approvals In 2021 Were Few But Included Many Firsts

While US biosimilar approvals have been somewhat thin on the ground in 2021 – with the pandemic driving inspection-related delays for multiple products – there were nevertheless several firsts this year, including the first two interchangeables and the first ophthalmic biosimilar.

Biosimilar perspectives 21-22
There are now seven FDA-approved biosimilars for adalimumab (Abbvie's Humira) • Source: Nielsen Hobbs; the Pink Sheet | Alamy image

With biosimilars increasingly gaining traction in the US in recent years thanks to multi-source competition on certain key products, as well as healthy uptake in treatment areas such as oncology, 2021 saw the US biosimilars market take further steps forward with a number of firsts.

These included the first US Food and Drug Administration designations of biosimilar interchangeability, the launch of the first interchangeable biosimilar, and the first

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