Even though US product has same cell line and drug product formulation as EU-approved Retacrit, Hospira subsidiary did not bridge to it in its US biosimilar application, meaning US FDA could not consider EU safety and efficacy experience.
FDA will complete its review of Pfizer Inc.'s proposed epoetin biosimilar without considering nearly a decade's worth of experience with the product in Europe, even though it is available and the company acknowledged the product is heavily related to its EU-approved counterpart.
Agency reviewers do not have access to data on the European-approved version of the company's proposed biosimilar of Amgen...
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The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
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