Waxman Says Biosimilar Pathway Will Push Applicants To BLA
The outgoing chairman of the House Energy and Commerce Committee said the new abbreviated biosimilar pathway FDA is now formulating likely will not attract many applicants.
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IMS Health official says the biologic and biosimilar markets are looming growth areas as small-molecule opportunities decline, but questions about the abbreviated biosimilar pathway linger.
Biosimilar products are not intended to be stand-alone development programs, agency stresses, noting that early analytical data can allow for more targeted clinical trials later.
The limited discussion of interchangeability in FDA’s initial biosimilar draft guidances has left some stakeholders clamoring for more details. Others say the agency’s demand for a “higher standard” of evidence to show interchangeability is misplaced and will inhibit use of the 351(k) pathway.