Dr. Reddy's, Merck KGaA partner on biosimilars


HYDERABAD, India — A generic drug maker in India and a German pharmaceutical company will collaborate to develop biosimilars.

Dr. Reddy's Labs and Merck KGaA subsidiary Merck Serono announced a partnership to develop biosimilar cancer treatments, most of them monoclonal antibodies, for global markets. Based in Darmstadt, Germany, Merck KGaA operates in the United States under the name EMD to distinguish itself from U.S. drug maker Merck.

The companies said the partnership would expand on Dr. Reddy's presence in the biosimilar space in emerging markets and allow it to participate globally. Currently, a small handful of companies — particularly Teva, Hospira and Novartis generics division Sandoz — dominates the biosimilars market in developed countries, mostly Europe. Part of the healthcare-reform law included a regulatory approval pathway for biosimilars in the United States, but regulations have yet to be finalized.

"We strongly believe that biosimilars is an important area of future growth, and these products give us the opportunity to provide affordable and innovative medicines to patients across the globe," Dr. Reddy's vice chairman and CEO G.V. Prasad said. "With the recent [European Medicines Agency] and [Food and Drug Administration] 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."

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