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Mundipharma announces their biosimilar trastuzumab (in-licensed from Celltrion) is available in Europe. This is Mundi’s third biosimilar to be launched in EU, but the second biosimilar TmAb, following MSD’s launch in March 2018.

Biocon announces Biocon and Mylan add insulin glargine 300 and pertuzumab to their collaboration.

Pfizer announces that it has received a CRL from the FDA for its BLA for biosimilar trastuzumab.  The FDA has highlighted the need for further technical information.

Celltrion’s rituximab biosimilar Truxima® is approved by the TGA. This is the second biosimilar approved in 4 months, following the approval of Sandoz’s Riximyo™ in December 2017.

Mylan announces EU deal with Fujifilm (with other territories still under negotiation) relating to Fujifilm’s biosimilar adalimumab, filed in EMA on 18 May 2017 with approval expected “late 2018”.  Mylan’s existing partner Biocon will receive payment...

Celltrion announces that the FDA has rejected its BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10).  The FDA complete response letter (CRL) followed a FDA warning letter received by Celltrion in January this year.  Celltrion promises that the BLAs will be r...

Samsung announces a royalty-bearing, global settlement with AbbVie enabling Samsung to launch its SB5 biosimilar adalimumab in Europe from 16 October 2018 and in the US from 30 June 2023.  The EU date is the same as AbbVie gave Amgen’s in its September 2018 global set...

Although details have not been announced by the companies, it appears that Korea’s Alteogen, and Malaysia’s Inno Bio Ventures are setting up a biosimilars JV in Malaysia, with an ASEAN focus.   Read more

Coherus announces that Judge Stark (US District Court for the District of Delaware) dismissed with prejudice Amgen’s patent infringement complaint alleging infringement of US8,273,707.
 

Sandoz announces that it has received a positive CHMP opinion for biosimilar infliximab Zessly®.