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The Biosimilars Council is arguing that the federal law governing biosimilars does not grant branded biologics an extra six months of exclusivity. Read More
Amgen neglected to provide Genentech with information on its manufacturing process for an Avastin biosimilar, violating statutory requirements, Genentech contends in a complaint. Read More
Over four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on justifying starting materials for chemical entity drug substances. Read More