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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.

Pfizer announces positive top line results for PF-05280586, biosimilar to Rituxan/MabThera.

US Court of Appeals (Fed Cir) affirms patent invalidity.

GE announces it is building a FlexFactory (single use technology with 2 x 2000L bioreactors) facility in China for Clover, which is expected to be up and running by the end of 2018. Clover intends to manufacture biosimilar etanercept for the Chinese market there.

Celltrion and Teva commence proceedings in District Court (Northern District of California) seeking DJ that 38 patents relating to trastuzumab are invalid, unenforceable and/or not-infringed.  This follows Celltrion/Teva’s US ABLA filing for biosimilar trastuzumab in ...