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US Biosimilars Enjoy A Year Of Firsts In 2021

Two Interchangeable Biosimilars And First Ophthalmic Biosimilar Approved

 
• By Dave Wallace

While US biosimilar approvals have been somewhat thin on the ground in 2021 – with multiple products seeing action delayed due to the FDA’s inability to conduct certain facility inspections during the COVID-19 pandemic – the market has nevertheless seen several firsts this year, including two interchangeability designations and the first ophthalmic biosimilar approval.

Eye USA Flag Face
The first US ophthalmic biosimilar was among 2021’s approvals • Source: Antony McAulay / Alamy Stock Photo

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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