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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 ...

Mochida receives approval for the first biosimilar etanercept in Japan, developed in Japan in collaboration with LG Chem, to be distributed in Japan by Ayumi.  The application took approximately 11 months to be approved by the PMDA.

Amgen and Allergan announce the first EU approval of biosimilar bevacizumab, to be marketed as Mvasti®.  Their application was filed with EMEA on 2 Dec 2016

Sandoz and Biocon announce a collaboration to develop and commercialise multiple biosimilar medicines.  The companies will share responsibility for development, manufacturing and regulatory approvals. Sandoz is responsible for leading commercialisation in the US & EU, w...

FDA approves Xbrane’s Phase III clinical trial for a biosimilar ranibizumab candidate Xlucane®.  Xbrane expects to enrol approximately 600 patients in 16 countries with the first patient expected in March 2019.