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Merck and Samsung Bioepis collaborate on biosimilar insulin Posted 28/02/2014

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.

Samsung Bioepis is South Korean electronics giant Samsung’s specialized biologicals unit, and is a joint venture set up between Samsung and Biogen Idec in December 2011 [1]. Merck and Samsung Bioepis made a deal to develop and commercialize biosimilars back in February 2013 [2].

MK-1293 is a biosimilar version of Sanofi’s blockbuster insulin treatment Lantus (insulin glargine). Under the terms of the agreement, the companies will collaborate on clinical development, regulatory filings and manufacturing of MK-1293. If approved, Merck will commercialize the biosimilar candidate.

The companies expect phase III clinical studies of the biosimilar in type 1 and type 2 diabetes to start soon. The two phase III trials listed on the US clinical trials website will each enrol 500 diabetic patients aged 18 years and above and will compare the biosimilar to Lantus in terms of anti-insulin antibodies and haemoglobin A1C level, among other outcomes. The trials will be completed in December 2014 (type 2 diabetes) and August 2015 (type 1 diabetes). No trials of MK-1293 were found on the EU clinical trials register, perhaps signalling the intention of the companies to go for US approval.

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Source: Clinicaltrials.gov, Merck

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