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LG Chem (formerly LG Life Sciences) obtains Korean regulatory approval for biosimilar etanercept.  This is the second biosimilar etanercept approved in Korea (after Samsung’s 2015 approval of Brenzys), and follows the Japanese approval of LG Chem’s biosimilar et...

TRpharm announces it is ready to launch biosimilar rituximab (developed by Dr Reddy’s) in Turkey, following approval on 30 Jan 2018.

Merck launches the first TmAb biosimilar in Europe by selling the product developed by Samsung Bioepis (SB3) as Ontruzant® in the UK.

Cadila announces it intends to file an aBLA for biosimilar pegfilgastim by end of 2019.

Celltrion announces it has begun development of a pembrolizumab biosimilar. Merck’s patents for this product are set to expire in 2028.

EC approves Celltrion’s Herzuma® (biosimilar trastuzumab), 2 months after the positive opinion from the CHMP on 14 December, 2017.  This is Celltrion’s third EU approval and the second EU biosimilar trastuzumab approved in 3 months.

Californian HQ’d BioSciences Corp & Shanghai based Mab-Venture announce a deal under which Mab-Venture will develop and manufacture biosimilars and BioSciences Corp will commercialise (through partners) those products in India, SAARC, MENA, Turkey, LatAm and Russi...

Lupin declares its intention to file an application in the EU and JP for biosimilar etanercept in July 2019.

Gedeon Richter announces refiling of MA for pegfilgrastim, following the completion of further clinical trials. GR withdrew its previous application in Dec 2016.  See Stada subsequent announcement here.

The second biosimilar AmAb, Samsung Bioepis’ Hadlima®, is registered on the ARTG in 2 different dosages.