Making the US FDA’s “Purple Book” listing of licensed biological products more like its small molecule predecessor, the “Orange Book,” could help promote biosimilar competition, better inform prescribing and dispensing, and boost market uptake, stakeholders told the US FDA at a Sept. 4 hearing.
Make The ‘Purple Book’ More Orange, US FDA Told At Biosimilars Hearing
Listing patent and exclusivity information for novel biologics, as is done in the ‘Orange Book’ for small molecules, would help inform biosimilar development, stakeholders say at hearing on facilitating biologic competition and innovation; AbbVie urges FDA to use the Purple Book to clarify the scope of interchangeability decisions.
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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.
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The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.
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Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?
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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.