FDA Searches For Clinical Trial Middle Ground At Biosimilar Hearing
FDA appeared to be searching for a way to limit the clinical trial requirements for biosimilars during a two-day public hearing on implementing a pathway for the products.
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As FDA prepares for another public hearing on the pathway, FTC says the rules requiring biosimilar applicants to share information with their reference product competitors could lead to anti-competitive issues and may be an ongoing concern.
European experiences with "totality of the evidence" method also seem to be shaping policy, according to FDA article in NEJM.
Brand and generic drug trade associations disagree with FDA’s proposal to have biosimilar sponsors pay a product development fee before even submitting a marketing application.