A 505(b)(2)-like pathway for biosimilars could make the agenda for the upcoming US Food and Drug administration bills, given its potential to streamline approval of some products and encourage innovation.
Could US FDA User Fee Bill Include The Long-Sought 505(b)(2) Pathway For Biosimilars?
Former FDA official says the pathway is needed to avoid wasted sponsor time and effort.
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The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.
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Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”
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Two recent disclosures from Xbrane Biopharma and Formycon demonstrate the evolving US Food and Drug Administration thinking about the need for Phase III trials to support biosimilar filings.
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Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.