United And Divided: Natco's Patent Challenge On Revlimid Leads Dr. Reddy's To Up Its Pitch
This article was originally published in PharmAsia News
MUMBAI - Natco Pharma's patent challenge earlier this month over Celgene's blockbuster multiple myeloma drug Revlimid (lenalidomide) has led India's Dr. Reddy's Labs to fast-track its own development of the product, which was brought under a restricted distribution plan by U.S. FDA due to its risky profile
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MUMBAI - Although U.S.-headquartered Celgene succeeded last year in preventing India's Dr. Reddy's Labs from conducting bioequivalence studies on its fast-growing multiple myeloma drug Revlimid (lenalidomide) - due to risk management and restricted distribution issues - it may have a much harder fight on its hands now
Dr. Reddy's is urging U.S. FDA to start now to define a policy that assures that restricted distribution programs and other types of Risk Evaluation and Mitigation Strategies won't be used to block generic drug approvals
MUMBAI - Highly profitable generic drugs - mainly in the oncology segment - are the latest targets for Indian pharmaceutical companies as margins rapidly shrink on commoditized off-patent drugs in the U.S. and several other markets. With that objective, India's Dr. Reddy's Labs and Natco, a company specializing in oncology drugs have signed a deal for the development, manufacture and supply of a basket of value added generic oncology drugs