Biosimilars/News
AMAC and GPhA hit back at Big Pharma over biosimilars
The Association of Mature American Citizens (AMAC) and the Generic Pharmaceutical Association (GPhA) have reacted strongly to the actions by Amgen and Genentech, which aim to make it more difficult for patients to get access to biosimilar medicines [1].
Biotech firms try to limit biosimilar substitution in US
FDA is still to approve a biosimilar and has yet to issue final guidelines outlining the regulatory requirements for approval of a biosimilar in the US.
China-based Innovent gains funding for expansion
Innovent Biologics (Innovent) has raised US$25 million in Series B financing to put towards the continued expansion of its pipeline and manufacturing capabilities.
Finox submits r-FSH biosimilar application to EMA
Finox Biotech announced on 20 December 2012 that it had submitted a Marketing Authorisation Application (MAA) for its biosimilar recombinant follicle stimulating hormone (r-FSH) to EMA on 30 October 2012.
ProCognia completes global glycoanalysis centre
Israeli biotech company ProCognia announced on 14 January 2013 the completion of its global centre of excellence for glycoanalytics.
Biosimilar trastuzumab made in tobacco plants
Canada-based PlantForm have altered tobacco plants to create a biosimilar version of Roche’s breast cancer drug Herceptin (trastuzumab).
CCM and Biocon make biosimilar insulin deal
Malaysia-based Chemical Company of Malaysia Berhad (CCM), announced on 14 December 2012 an agreement between its subsidiary, CCM Pharmaceuticals Sdn Bhd (CCMP), and India-based Biocon, giving CCMP exclusive licence and distribution rights to market, sell and distribute a range of insulin products in Malaysia and Brunei.
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.
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.
