Read our latest updates & insights

FDA approves Mylan/Biocon trastuzumab biosimilar Ogivri® for all “on-label” indications.  This is the first US approved trastuzumab biosimilar, and Mylan’s first US biosimilar approved.

The Australian government’s biosimilar uptake initiative results in changes to PBS listing for Samsung’s Brenzys® in Australia. “A” flagging (substitution at the pharmacy level) remains unchanged.

Sandoz’s biosimilar etanercept (Erelzi®)  approved in Australia in 3 dosages, the second approved biosimilar etanercept.

Sandoz’s biosimilar rituximab, Riximyo® approved in Australia, following its approval in Europe 5 months earlier.

German Formycon announced it intends to bring biosimilar ranibizumab to the US market in 2020 with commercialisation partner Bioeq (JV between Santo and Polpharma).

Biocon launches Krabeva®, biosimilar bevacizumab, in India.

Samsung Bioepis receives regulatory approval for EU’s first biosimilar trastuzumab, Ontruzant® (to be marketed by MSD) for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

Roche sues Pfizer in District Court of Delaware, alleging infringement of 40 patents, the first US lawsuit involving trastuzumab.

Amgen announces US launch of new ENBREL Mini® single-dose prefilled cartridge with AutoTouch® reusable autoinjector.

Amgen/Allergan announce the EMA’s CHMP has adopted a positive opinion for ABP 215, biosimilar to Avastin® (bevacizumab) for the same indications as the originator. Read more