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Marvel withdraws biosimilar insulin applications

EMA announced on 27 November 2012 that it had been informed by Marvel LifeSciences (Marvel) that the company would be withdrawing its authorization applications for its three biosimilar human insulins.

Approval of first biosimilar G-CSF in Japan

Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced on 21 November 2012 that they had gained approval for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan.

The latest biosimilars agreements

Biosimilar is still the hottest subject around.  Just a few of the latest collaborations for the development of biosimilars include agreements made on 6 November 2012 between AET BioTech and BioXpress Therapeutics; Oncobiologics and Boston Oncology; ProCognia and UniTargetingResearch; and the Innovent Biologics and Pharmatech Associates agreement made on 1 November 2012.

Japanese firms developing biosimilars

Japanese firms are definitely not dragging their heels when it comes to biosimilars. The latest agreement for biosimilar development involves LG Life Sciences (LGLS) and Mochida Pharmaceutical (Mochida), while joint venture Fujifilm Kyowa Kirin Biologics has announced it is to initiate development of a biosimilar version of bevacizumab.

Reliance Life Sciences starts ‘similar’ infliximab trial in India

Reliance Life Sciences is starting a clinical trial for a ‘similar biologic’ version of infliximab in patients suffering with rheumatoid arthritis in India.

STC Biologics receives US$2.5 million for biosimilar mAb development

US-based biotechnology company STC Biologics announced on 10 October 2012 that it had entered into a US$2.5 million phase II Small Business Innovation Research (SBIR) contract with the National Cancer Institute (NCI) to develop a STC101, a biosimilar monoclonal antibody (mAb), for the treatment of cancer.

Samsung halts biosimilar rituximab development

South Korean electronics giant Samsung has halted clinical development for the biosimilar version (SAIT101) of Roche’s Rituxan/MabThera (rituximab).

TNF copy biological approved in China

China-based Simcere Pharmaceutical Group (Simcere) announced on 9 May 2011 that Shanghai Celgen Bio-Pharmaceutical (Shanghai Celgen) has received approval for Qiangke – a copy biological version of etanercept – by the Chinese authorities.

Brazil to manufacture follow-on adalimumab

The Brazilian Ministry of Health (Ministério da Saúde) announced on 5 April 2011 that it would be entering into an agreement with PharmaPraxis to manufacture a biosimilar, or follow-on version, of Abbott’s monoclonal antibody Humira (adalimumab).

Medicago and Cellectis in successful biosimilars research collaboration

Canadian biopharmaceutical company Medicago and Cellectis plant sciences, a subsidiary of Cellectis SA, French genome engineering specialist, announced on 4 October 2012 the successful completion of the first step in their research collaboration to improve therapeutic proteins produced in tobacco plants.

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