Just what the doctor ordered

HYDERABAD, India—Biosimilars are getting a boost as two moreindustry giants have announced a partnership based on follow-on biologics. Dr.Reddy's Laboratories Ltd. and Merck Serono, a division of Merck KGaA, haveannounced a collaboration for the co-development of a portfolio of biosimilarcompounds in oncology. The partnership will be primarily focused on monoclonalantibodies and will cover the co-development, manufacturing andcommercialization of the compounds around the globe, with select countryexceptions.

We strongly believe that biosimilars is an important areaof future growth, and these products give us the opportunity to provideaffordable 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 anysignificant 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 globalpartnership."

Under the terms of the agreement, Merck Serono and Dr.Reddy's will co-develop the chosen molecules, with Dr. Reddy's responsible forleading early product development and completing Phase I development. OncePhase I is complete, Merck Serono will assume responsibility for manufacturingthe compounds and leading Phase III development. The agreement is based on fullresearch and development cost sharing.

Merck Serono will be in charge of commercializationglobally, with the exception of the United States, markets where Dr. Reddy'smaintains exclusive rights and certain emerging markets, which will beco-exclusive. Dr. Reddy's will receive royalty payments upon commercialization,and the partners will co-commercialize in the United States on a profit-sharingbasis. Financial details were not disclosed.

The agreement marks the first time the two companies haveworked together, though Dr. Gangolf Schrimpf, manager of corporate externalcommunications for Merck KGaA, says Dr. Reddy's is "a natural partner for MerckSerono." Dr. Reddy's has ample experience with biosimilars, having launchedfour biosimilars molecules to date, and also boasts a presence in thebiosimilar market in several emerging markets.

"Combining [Dr. Reddy's] experience in generics, biosimilarsand the emerging markets, with our expertise in biotechnology development,manufacturing and commercialization makes a strong partnership to deliver onthe promise of biosimilars," he explains.

Schrimpf says biosimilars represent "a sizable marketopportunity," with IMS Health reporting that the biosimilars markets isexpected 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 totalbiologics market."

The collaboration is one of several to be made so far inrecent months as more and more drugs near the patent cliff and companies searchout new, more cost-effective compounds to replace off-patent blockbusters.Samsung Biologics ended 2011 with the Dec. 5 announcement of a joint venturewith Biogen Idec that will develop, manufacture and market biosimilars. Amgenand Watson announced a partnership later that month as well, a collaboration todevelop and commercialize worldwide several oncology-related antibodybiosimilar medicines, to be sold under a joint Amgen/Watson label. Earlier thisyear, Celerion and Ricerca Biosciences announced "the Biosimilars Alliance" forthe preclinical and early clinical assessment of biologics.

Biosimilars have been getting significant regulatoryattention as well, with the U.S. Food and Drug Administration having issuedthree draft guidance documents on development of the follow-on biologics. Theguidance documents cover issues such as whether or not compounds requirefurther studies to demonstrate biosimilarity, one of the leading concerns anddraws of biosimilars, as the characteristics and pharmacokinetic profiles theyshare with established drugs generally require companies to perform fewerstudies, allowing the drugs to get to market sooner.

"Sharing know-how, risks and rewards is the right approachto enter the emergent biosimilars market and will be a win-win for bothparties. It further strengthens Merck Serono's promise to live science andtransform lives, by increasing access to quality medicines for patients,physicians and payers," Stefan Oschmann, CEO of Merck Serono, said in a pressrelease.

Amgen 

Watson 

Celerion 

Ricerca Biosciences 

U.S. Food and Drug Administration