This investment will be in addition to the already disclosed investment plan for its biosimilars business of Euros 100 million for 2014 [1]. The company plans to invest an additional US$130–150 million in biosimilars for 2015, with the exact amount depending on the outcome of ongoing phase I trials.

In addition, the company plans to expand on existing partnerships with India’s Dr Reddy’s Laboratories (Dr Reddy’s) and Brazil’s Bionovis with an in-licensing agreement for a late-stage biosimilar. Initially, the biosimilar is intended for smaller, emerging markets.

Merck KGaA’s biologicals division, Merck Serono, made an agreement with India-based generics manufacturer Dr Reddy’s in June 2012 to co-develop biosimilar cancer drugs [2]. In November 2013, Merck Serono, made a partnership agreement between Brazil’s Bionovis, Fiocruz and Instituto Vital Brazil with Germany’s Merck Serono for the production of six ‘similar biotherapeutic products’ for cancer and arthritis [3]. 

Between 2015 and 2016, Merck KGaA plans to initiate two to five phase III clinical trials for its biosimilar candidates.

Editor’s comment
It should be noted that ‘similar biotherapeutic products’ approved in Brazil might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The European Medicines Agency (EMA) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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References
1.   GaBI Online - Generics and Biosimilars Initiative. Merck KGaA to invest Euros 100 million in biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 10]. Available from: www.gabionline.net/Biosimilars/News/Merck-KGaA-to-invest-Euros-100-million-in-biosimilars 
2.   GaBI Online - Generics and Biosimilars Initiative. Merck KGaA and Dr Reddy’s to collaborate on biosimilar mAbs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 10]. Available from: www.gabionline.net/Biosimilars/News/Merck-KGaA-and-Dr-Reddy-s-to-collaborate-on-biosimilar-mAbs 
3.   GaBI Online - Generics and Biosimilars Initiative. Merck Serono to transfer technology for six similar biotherapeutic products to Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 10]. Available from: www.gabionline.net/Biosimilars/News/Merck-Serono-to-transfer-technology-for-six-similar-biotherapeutic-products-to-Brazil 

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