Biosimilars/News
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.
Teva halts phase III biosimilar rituximab trial
Israeli generics giant Teva Pharmaceutical Industries (Teva) has suspended its phase III trial of its biosimilar version (TL011) of Roche’s Rituxan/MabThera (rituximab).
EMA receives second application for biosimilar infliximab
According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in September 2012, the agency will be reviewing a second application for a biosimilar version of infliximab.
Bioton and Medipolis sign insulin analogue technology licensing agreement
Polish biotechnology company Bioton and Finnish-based contract research organisation (CRO) Medipolis GMP (Medipolis) have signed a licensing agreement on the manufacturing technology of an insulin analogue.
Roche does not see a threat from biosimilars until 2015
Switzerland-based drugmaker F. Hoffmann-La Roche (Roche) expects results from 19 late-stage clinical trials over the next 18 months to provide a stream of products to offset potential near-term threats to its cancer drugs Herceptin (trastuzumab) and Rituxan (rituximab).
Sun recalls biosimilar brain treatment
India-based Sun Pharmaceutical Industries (Sun Pharma) is once again in the news, but for the wrong reasons.
