Center for Biosimilars1d
Real-World Data Confirm Safety of Switching Between Ranibizumab Biosimilars
Patients with diabetic macular edema previously treated with a ranibizumab biosimilar in India experience comparable safety ...
Center for Biosimilars13d
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 ...
pharmaphorum2d
FDA approves Herceptin biosimilar as US patent expires
which has already got a biosimilar to Roche’s Avastin (bevacizumab) cancer drug backed by the FDA. Amgen already has a biosimilar of AbbVie’s Humira (adalimumab) approved in the US ...
Business Wire17d
Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA
“We have a longstanding and productive partnership with Amneal, and we are pleased to be advancing these two important products to the U.S. biosimilar market. We remain focused on our globalization ...
Capacity push and new drugs critical for Aurobindo's health
A delay in drug approvals in the US market remains a concern for Aurobindo. The company stated that eight ANDAs (abbreviated ...