Just what the doctor ordered
HYDERABAD, India—Biosimilars are getting a boost as two more industry giants have announced a partnership based on follow-on biologics. Dr. Reddy's Laboratories Ltd. and Merck Serono, a division of Merck KGaA, have announced a collaboration for the co-development of a portfolio of biosimilar compounds in oncology. The partnership will be primarily focused on monoclonal antibodies and will cover the co-development, manufacturing and commercialization of the compounds around the globe, with select country exceptions.
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," G.V. Prasad, vice-chairman and CEO of Dr. Reddy's Laboratories, said in a press release. "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."
Under the terms of the agreement, Merck Serono and Dr. Reddy's will co-develop the chosen molecules, with Dr. Reddy's responsible for leading early product development and completing Phase I development. Once Phase I is complete, Merck Serono will assume responsibility for manufacturing the compounds and leading Phase III development. The agreement is based on full research and development cost sharing.
Merck Serono will be in charge of commercialization globally, with the exception of the United States, markets where Dr. Reddy's maintains exclusive rights and certain emerging markets, which will be co-exclusive. Dr. Reddy's will receive royalty payments upon commercialization, and the partners will co-commercialize in the United States on a profit-sharing basis. Financial details were not disclosed.
The agreement marks the first time the two companies have worked together, though Dr. Gangolf Schrimpf, manager of corporate external communications for Merck KGaA, says Dr. Reddy's is "a natural partner for Merck Serono." Dr. Reddy's has ample experience with biosimilars, having launched four biosimilars molecules to date, and also boasts a presence in the biosimilar market in several emerging markets.
"Combining [Dr. Reddy's] experience in generics, biosimilars and the emerging markets, with our expertise in biotechnology development, manufacturing and commercialization makes a strong partnership to deliver on the promise of biosimilars," he explains.
Schrimpf says biosimilars represent "a sizable market opportunity," with IMS Health reporting that the biosimilars markets is expected to reach a total worth of between $11 billion and $25 billion by 2020, "representing a 4-percent and 10-percent share, respectively, of the total biologics market."
The collaboration is one of several to be made so far in recent months as more and more drugs near the patent cliff and companies search out new, more cost-effective compounds to replace off-patent blockbusters. Samsung Biologics ended 2011 with the Dec. 5 announcement of a joint venture with Biogen Idec that will develop, manufacture and market biosimilars. Amgen and Watson announced a partnership later that month as well, a collaboration to develop and commercialize worldwide several oncology-related antibody biosimilar medicines, to be sold under a joint Amgen/Watson label. Earlier this year, Celerion and Ricerca Biosciences announced "the Biosimilars Alliance" for the preclinical and early clinical assessment of biologics.
Biosimilars have been getting significant regulatory attention as well, with the U.S. Food and Drug Administration having issued three draft guidance documents on development of the follow-on biologics. The guidance documents cover issues such as whether or not compounds require further studies to demonstrate biosimilarity, one of the leading concerns and draws of biosimilars, as the characteristics and pharmacokinetic profiles they share with established drugs generally require companies to perform fewer studies, allowing the drugs to get to market sooner.
"Sharing know-how, risks and rewards is the right approach to enter the emergent biosimilars market and will be a win-win for both parties. It further strengthens Merck Serono's promise to live science and transform lives, by increasing access to quality medicines for patients, physicians and payers," Stefan Oschmann, CEO of Merck Serono, said in a press release.
U.S. Food and Drug Administration