How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline | Rothwell, Figg, Ernst & Manbeck, P.C.
FDA has not approved any biosimilars in 2021 after only approving three in 2020. EMA approves second Novolog® (insulin aspartate), fifth Avastin® (bevacizumab), eighth Neulasta® (pegfilgrastim), and twelfth Humira® (adalimumab) biosimilars, and withdraws approval of an adalimumab biosimilar and a pegfilgrastim biosimilar. Given the increasing number of approved biosimilars in Europe, biosimilar manufacturers are increasingly deciding to not market their products due to commercial reasons. As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing num...
Source: jdsupra.com