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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®.

EMA’s CHMP adopted a positive opinion for ABP 980, Amgen/Allergan’s trastuzumab biosimilar Kanjinti®, 12 months after they announced filing the EC application.

Mundi and Celltrion enter exclusive distribution and marketing agreement for biosimilar trastuzumab, Herzuma®, for 7 EU countries including UK, DE and IT.

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.