FDA: Biosimilars Review 2021

Typically, in the USA, the list prices of biosimilars at launch have been 15% to 35% lower than that of the corresponding reference products, and the biosimilar market is estimated to lead to savings of $133 billion over the next five years.1,2 However, the Food and Drug Administration faced challenges in the timely review of biosimilar applications during the pandemic; 10 biosimilars were approved in 2019, but only 3 and 2 biosimilars have been approved in 2020 and 2021 so far, respectively.3 We take a look at the biosimilar product approvals and pipeline in 2021 and their long-term implications for the pharmaceutical landscape.

FDA approvals for biosimilars in 2021

Byooviz (ranibizumab biosimilar)