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For authorized biosimilars to achieve full acceptance in the marketplace, it is crucial that they are considered to be therapeutically equivalent and interchangeable with the brand reference product.
With the first marketing authorization application for a biosimilar monoclonal antibody now under consideration at the European Medicines Agency, what are the critical issues for regulators?
In an environment where the regulatory and reimbursement authorities continue to raise the bar for new oncology therapies, how are sponsors adapting clinical trial designs?
The Multiple Myeloma Research Foundation (MMRF) has developed innovative, collaborative business models to reshape the R&D enterprise with the single-minded focus of accelerating the development of new treatments for patients to extend their lives and lead to a cure.