Dr. Reddy’s Laboratories, Merck Serono to develop biosimilars

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced a co-development agreement  with Hyderabad-based Dr. Reddy's Laboratories for a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs).

The agreement, based on full cost sharing by the two companies, covers co-development, manufacturing and commercialisation of the compounds around the globe, with some specific country exceptions.

Biologics, or large molecule pharmaceuticals are complex, highly targeted and generally expensive therapies that are a growing contributor to overall global healthcare spending. The burden on patients and payers has resulted in an increasing demand for generic alternatives to off-patent biologics, most commonly known as biosimilars.   Patent expiries in the immediate future present opportunities to pharmaceuticals to cater to the global population with high quality, low cost equivalents of proprietary biosimilars.

Dr Reddy's has been a pioneer and leader in the biosimilars space through proven product development capabilities and the launch of four biosimilars molecules to date. The agreement with Merck Serono expands on Dr. Reddy's presence in the biosimilar segment in select emerging markets and enables participation globally. 

"With the recent EMA and FDA guidance on biosimilars, it is clear that any significant player in the field will need strong biologics development, manufacturing and commercialization capabilities. Merck Serono's and Dr. Reddy's joint expertise in these fields makes for a powerful global partnership,'' says G V Prasad, vice chairman and CEO of Dr Reddy's Laboratories.

Stefan Oschmann, CDO, Merck Serono says,''Our expertise in developing, manufacturing, and commercialising biopharmaceuticals gives us a clear advantage in the biosimilars field, and the partnership with Dr. Reddy's will bring their first-in-market experience in biosimilars, as well as their expertise in generics and Emerging Markets, to the table.''