Biosimilars/News

Rituximab non-originator biological approved in Russia

Biosimilars/News | Posted 25/04/2014

Russian biotechnology company Biocad announced on 17 April 2014 that the Russian Ministry of Health has approved the company’s rituximab non-originator biological, AcellBia (BCD-020). The drug is a non-originator biological of Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).

Amgen starts phase III trial for biosimilar rituximab

Biosimilars/News | Posted 26/09/2014

Biologicals major Amgen is carrying out a global phase III clinical trial for a biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).

Biosimilar infliximab launched in Japan

Biosimilars/News | Posted 05/12/2014

Japanese pharma firm Nippon Kayaku announced on 28 November 2014 the launch of its infliximab biosimilar, Infliximab BS, in Japan.

Biocad and Epirus to invest in follow-on biological products in Brazil

Biosimilars/News | Posted 31/10/2013

Biocad Russia is to open a US$40 million facility to produce three follow-on biological products in Brazil.

Momenta gains approval to start biosimilar adalimumab trial in Europe

Biosimilars/News | Posted 12/12/2014

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 December 2014 the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a clinical trial application to initiate a clinical trial for its adalimumab biosimilar, M923.

Stada to in-license adalimumab biosimilar

Biosimilars/News | Posted 05/12/2014

German generics giant Stada Arzneimittel (Stada) announced on 18 November 2014 that it was in negotiations to in-licensing an adalimumab biosimilar.

Amgen expands biosimilars programme

Biosimilars/News | Posted 28/11/2014

Biologicals major Amgen is expanding its biosimilars portfolio to include nine different molecules.

Amgen launches biosimilars info app

Biosimilars/News | Posted 21/11/2014

Biologicals major Amgen has launched an app which aims to provide a source of information about biosimilars.

Amgen sues Sandoz over filgrastim biosimilar

Biosimilars/News | Posted 14/11/2014

Biologicals major Amgen is suing Sandoz to stop the biosimilars maker from marketing a biosimilar of its top-selling product Neupogen (filgrastim) in the US. Amgen claims in its lawsuit that Sandoz did not follow the rules for biosimilar development.

Study into switching from Aranesp to biosimilar epoetin alfa

Biosimilars/News | Posted 07/11/2014

Biologicals major Amgen has started recruiting patients for a clinical trial to study the effect of switching patients from the originator biological Aranesp (darbepoetin alfa) to biosimilar epoetin alfa, in other words, from a long-acting to a short-acting epoetin.