Biosimilars

© GettyImages/ardaguldogan

FDA reviewing higher dose Hyrimoz biosimilar

By Jane Byrne

The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.

© GettyImages/Olivier Le Moal

Amneal secures second US biosimilars approval

By Jane Byrne

Last week saw the US Food and Drug Administration (FDA) approve the Biologics License Application (BLA) from Amneal Pharmaceuticals Inc for bevacizumab-maly, a biosimilar referencing Avastin, the Roche/Genentech product.

© GettyImages/Dilok Klaisataporn

Pfizer sells biosimilars plant in China to Wuxi

By Jane Byrne

Pfizer is selling a biologics manufacturing unit in the eastern city of Hangzhou to WuXi Biologics, despite the US pharma giant having ploughed US$350m into the site in 2016 to develop biosimilars.

© GettyImages/ChooChin

UK market sees additional Herceptin biosimilar

By Jane Byrne

Accord Healthcare has announced the launch of a Herceptin biosimilar in the UK. Zercepac is the first monoclonal antibody (mAb) and fourth biosimilar launched by the company in Europe.

Follow us

Products

View more

Webinars