US Biosimilars Enjoy A Year Of Firsts In 2021

Two Interchangeable Biosimilars And First Ophthalmic Biosimilar Approved

02 Dec 2021

While US biosimilar approvals have been thin on the ground in 2021 – with products 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: Alamy

With biosimilars 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 FDA designations of biosimilar interchangeability, the launch of the first interchangeable biosimilar, and the first...