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Mabion signs agreement with Mylan for rituximab biosimilar

Global specialty pharmaceuticals firm Mylan has reached an agreement with Mabion, a leading biotechnology company in Poland, for the exclusive right to commercialize their rituximab biosimilar candidate in the European Union (EU).

Eagle moves into biosimilars with Arsia acquisition

Specialty pharmaceuticals company Eagle Pharmaceuticals (Eagle) has signed an agreement to acquire Arsia Therapeutics (Arsia), the biotechnology company behind cutting-edge technology that enables intravenous drugs to be administered by injection.

Top 10 most read GaBI Online articles in 2016

It has once again been a busy year for biosimilars. An important milestone for biosimilars in 2016 was the adoption by the European Medicines Agency (EMA) of new guidance on monitoring biologicals. While the US Food and Drug Administration (FDA) approvals of infliximab and adalimumab biosimilars were also important events in 2016. Other subjects of interest for biosimilars were the differences between biosimilars and reference biologicals, biosimilarity and switching biosimilars. Biosimilars remain the hot topic for GaBI Online during 2016.

Strategic biologicals alliance between Sanofi and JHL Biotech in China

Sanofi and JHL Biotech (JHL) announced on 5 December 2016 that they were forming a strategic biologics alliance in China.  The two companies will be collaborating on the development and commercialization of biological therapeutics in China, with potential for further international expansion.

Sun Pharma to acquire Russia’s Biosintez

Sun Pharmaceutical Industries (Sun Pharma) announced on 23 November 2016 its acquisition of Russian pharmaceutical company JSC Biosintez at a cost of US$24 million, demonstrating the company’s commitment to the Russian market.

India’s Cipla to establish biosimilars facility in South Africa

Indian generics maker Cipla has announced a deal to set up South Africa’s first biosimilars manufacturing facility, at an estimated cost of over US$91 million.

Richter and DM Bio make deal for trastuzumab biosimilar

Hungary-based Gedeon Richter (Richter) announced on 19 October 2016 that it had signed a technology transfer and in-licensing agreement with South Korea-based biologicals specialist DM Bio for the development and commercialization of DM Bio’s trastuzumab biosimilar.

China’s CFDA rejects more than 80% of drug applications

Data released by China Food and Drug Administration (CFDA) revealed that between January 2015 and January 2016, 1,184 drug applications submitted to CFDA were rejected or withdrawn due to incomplete or fraudulent clinical data.

Dr Reddy’s expands collaboration with Amgen in India

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) is expanding its collaboration with US-based biologicals specialist Amgen with an agreement to market and distribute three of Amgen’s biological medicines in India in the therapy areas of oncology and osteoporosis.

Sun Pharma announces Japanese distribution pact with Mitsubishi Tanabe

Sun Pharmaceutical Industries (Sun Pharma) has announced it will transfer marketing authorizations for 14 of its prescription drugs to Mitsubishi Tanabe Pharma (Mitsubishi Tanabe), allowing the company to manufacture and market them in Japan.