Manufactured by Dr. Reddy's Laboratories Ltd.

Biosimilars

Stefan Oschmann, Mitglied der Geschäftsleitung bei Merck: „Unsere Kompetenz in der Entwicklung, Herstellung und Vermarktung von Biopharmazeutika verschafft uns einen klaren Vorteil auf dem Gebiet der Biosimilars“.

Merck and Company, based in Hyderabad, India, Dr. Reddy's Laboratories have announced a partnership in the area of ​​biosimilars in oncology. As part of the collaboration, the substances are being developed worldwide except some countries jointly produced and marketed.

Darmstadt - The partnership between Merck Serono and Dr. Reddy's is the first step of Merck in the field of biosimilars represents the division had begun in the last year, building on the existing expertise in biopharmaceuticals and its growing presence in key markets as well as in some emerging countries to explore possible. In 2012, a unit was established already "biosimilars". It is in the Swiss canton of Vaud, located where the largest production of the division of biological pharmaceuticals are.

The structure of the agreement provides for the joint development of the included in the agreement, Merck and Dr. Reddy's molecules. In the early product development and complete Phase I Development, Dr. Reddy's will take over the lead. Upon completion of Phase I, the Merck Serono division is the production of substances take over and control the phase III development.

The agreement is based on a complete breakdown of research and development costs. Merck Serono will be responsible for worldwide marketing outside the U.S., with the exception of some emerging countries, which are to be processed jointly or the Dr Reddy's will retain exclusive rights. From the time of marketing Dr. Reddy's will receive royalty payments from Merck. In the United States, the partners will market the products on the basis of profit sharing together.

"Our expertise in the development, manufacture and marketing of biopharmaceuticals gives us a clear advantage in the field of biosimilars. Dr. Reddy's will bring the experience as a pioneer in the market for biosimilars and generic skills and emerging countries in this partnership, "said Stefan Oschmann of the Merck Serono division is responsible as a member of the Executive Board of Merck. "The sharing of expertise, risks and profits is the right way to enter the evolving market for Biosmilars and will be of benefit to both sides. The promise of the Merck Serono division, live science and to change lives is supported by patients and physicians with improved access to quality medicines is allowed, while the value of the payers offered is significantly improved at the same time. "

GV Prasad, Vice-Chairman and CEO, Dr. Reddy's Laboratories, said: "We firmly believe that biosimilars are an important area of ​​future growth and these products give us the opportunity to offer patients all over the world affordable and innovative medicines to. Since the last guidelines of the EMA and FDA biosimilars has become clear that every major company in this area requires appropriate skills in the development of biological preparations, their production and marketing. The joint expertise of Merck and Dr. Reddy's in these areas will lead to a strong global partnership. "

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