While the AAM is lobbying for a renewed focus on domestic drug production amid fresh concerns about the globalization of the US pharmaceutical drug supply chain, the association has urged US Congress to have confidence in FDA oversight, insisting that “the US has one of the safest drug supply chains in the world.”

Korean firm Celltrion is aiming to move production of insulin pens inside Korea “for the first time” and break the stranglehold of Big Pharma insulin players in the market by launching a biosimilar product in 2025.

Mylan and Lupin have revealed when they expect to launch their etanercept biosimilar, Nepexto, in Europe after receiving formal European Commission approval.

The Alvogen group of companies has unveiled Adalvo as the new identity for its B2B business unit. In an exclusive interview, general manager Anil Okay talks to Generics Bulletin about the reasons behind the rebranding, what makes it unique in the B2B sphere, and the significance of 2023 for Adalvo’s strategy.

Amgen’s burgeoning biosimilar presence continues to grow apace and now the company has eyes firmly on the US market for eculizumab after brokering a deal with originator Alexion. The biosimilars developer chose to settle on three of Alexion’s patents ahead of a trial later this year.

Mylan first announced plans to develop a biosimilar of the Botox cosmetic and therapeutic brands back in 2018 through an alliance with Revance Therapeutics. More than two years later, a verdict has been reached by the company.