Biosimilars/News
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.
Biosimilar merger for Epirus and collaboration for Catalent
Mergers and collaborations are still in vogue in the biosimilars arena. The latest firms to announce deals are Epirus Biopharmaceuticals (Epirus), which will merge with Zalicus; and Catalent, which has agreed to a biosimilar development collaboration with Zhejiang Hisun Pharma.
Sandoz advances biosimilars pipeline
Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 28 April 2014 that it had reached several important milestones in the development of biosimilar etanercept, filgrastim and pegfilgrastim.
Lupin and Yoshindo start biosimilars joint venture
Indian generics’ manufacturer Lupin Pharmaceuticals (Lupin) announced on 21 April 2014 that the company had entered into a joint venture with Japanese generics maker Yoshindo for a biosimilars joint venture in Japan.
Brazil’s ANVISA approves Cristália for production of ‘follow-on biological products’
Brazilian drugmaker Cristália has taken a step closer to its goal of producing ‘follow-on biological products’ domestically after receiving clearance from the country’s drug regulator, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA).
FDA to review insulin biosimilar
Eli Lilly and Boehringer Ingelheim announced on 20 December 2013 that the US Food and Drug Administration (FDA) had accepted their New Drug Application (NDA) for a biosimilar insulin product.
