Biosimilar Sponsors Push US FDA To Speed Up Supplement Reviews
Although the agency committed to six-month reviews of biosimilar and interchangeable supplemental applications, stakeholders say that time should, at minimum, be cut in half. Meanwhile, PhRMA's comments on a supplemental applications draft guidance urge the FDA to ensure interchangeability is demonstrated for all indications, even when some of those uses are ineligible for approval due to patent and exclusivity protection.
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Biosimilar development programs also are expected to increase, a promising sign for the growing sector, but those fees remained unchanged.
Sponsors may submit supplemental applications for additional indications in advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.
Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.