Biosimilars/News
Biocon and Mylan challenge Indian ban on trastuzumab ‘similar biologics’
India-based biologicals specialist Biocon and US generics maker Mylan have challenged the Delhi High Court’s interim order that barred them from using Switzerland-based drug giant Roche’s data to sell their ‘similar biologic’ versions of Roche’s breast cancer blockbuster Herceptin (trastuzumab).
Merck and Samsung Bioepis collaborate on biosimilar insulin
US pharma giant Merck and Korean electronics giant Samsung’s specialized biologicals unit, Samsung Bioepis, announced on 10 February 2014 that they had expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293, a biosimilar insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes.
Alvogen launches infliximab biosimilar in Europe
US generics company Alvogen announced on 13 February 2014 that it had launched the infliximab biosimilar Inflectra in Central and Eastern Europe in collaboration with Hospira.
EMA approves follitropin alfa biosimilar
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 23 January 2014 that it had recommended the granting of a marketing authorization for biosimilar infertility treatment Bemfola (follitropin alfa).
Trastuzumab ‘similar biologic’ to be launched in India
India-based Biocon announced on 18 January 2013 that it was introducing its trastuzumab ‘similar biologic’ CANMAb to the Indian market.
Mylan launches trastuzumab ‘similar biologic’ in India
Generics giant Mylan announced on 3 February 2014 that its subsidiary, Mylan Pharmaceuticals Private Limited, had launched its trastuzumab ‘similar biologic’ Hertraz to the Indian market.
Roche wins case against Herceptin ‘similar biologics’ producers
Generic drugmaker Mylan and its partner Biocon have been successfully sued by Roche for failing to carry out sufficient clinical trials on ‘similar biologics’ of the breast cancer blockbuster Herceptin (trastuzumab). Mylan and Biocon had recently announced plans to launch their ‘similar biologics’ in India [1, 2].
Pfizer to start phase III biosimilar trastuzumab trial
Pharma giant Pfizer is to start a global phase III trial for a biosimilar version of trastuzumab.
First biogeneric for Iran
Iran has developed the country’s first ‘biogeneric’ drug for cancer patients. The announcement was made in the presence of Iran’s Deputy Health Minister Hassan Hashemia at the beginning of February 2014, according to a report in the Tehran Times.
Celltrion files infliximab patent lawsuit in US
South Korean biotechnology company Celltrion filed a lawsuit on 31 March 2014 in a federal court in Massachusetts seeking a declaratory judgement that Janssen Biotech’s (Janssen) remaining patents on the reference drug Remicade (infliximab) are invalid and unenforceable.
