Managed Healthcare Executive9d
The Biosimilars Report Card
It has been 10 years since the first biosimilar was approved by the FDA. The grades on how the market for biosimilars has ...
pharmaphorum1d
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 ...
Amneal Pharmaceuticals BLA submissions for denosumab biosimilars accepted by FDA
Amneal Pharmaceuticals (AMRX) “announced that the FDA has accepted for review its Biologics Licensing Application for two proposed denosumab ...
Business Wire11d
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 ...
pharmaphorum2d
NICE backs first ophthalmic bevacizumab for NHS use
and Novartis' Lucentis (ranibizumab), approved biosimilars of those two drugs, and Roche's Vabysmo (faricimab). Compounded bevacizumab formulations are sometimes used to treat wet AMD but ...
Nasdaq11d
Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA
Amneal and mAbxience currently partner on ALYMSYS®, a bevacizumab biosimilar, which was launched in 2022. “Amneal is building its position in the U.S. biosimilars market as this next wave of ...