The Center for Biosimilars

FDA Approves Coherus’ Cimerli as Interchangeable Biosimilar to Ranibizumab

August 03, 2022

Another ranibizumab biosimilar, Byooviz, is approved, but Coherus’ product is the first deemed interchangeable, which involves additional FDA requirements that allow substitution without intervention of the prescribing clinician.

IGBA Launches Panel of 13 CEO-Level Advisers

February 07, 2022

The IGBA maintains dialogue with other national, regional, and international bodies to ensure patient access to high-quality, safe, and effective medicines while reducing costs in pharmaceutical care.

Alvotech Enters Licensing Agreement With BiosanaPharma for Development of Biosimilar for Xolair

February 02, 2022

Xolair, the only currently approved product containing omalizumab, was first approved in 2003. AVT23 is an investigational compound and has not received regulatory approval in any country. Current sales of Xolair are estimated at $3.3 billion.