FDA Approves First Interchangeable Biosimilar to Perjeta (pertuzumab) Genentech
On November 13, 2025, the FDA approved Poherdy (pertuzumab-dpzb, by Shanghai Henlius Biologics Co., Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, by Genentech Inc.). U.S. Food and Drug Administration This marks the first biosimilar approved for Perjeta. U.S. Food and Drug Administration Indications for Poherdy include: The approval rests on comprehensive data comparing product […]
Unlocking Flexibility: FDA’s 2025 Guidance on pH Adjuster Waivers for Complex Generics
Introduction The guidance addresses how generic-drug applicants (via an Abbreviated New Drug Application, ANDA) may request a waiver under 21 CFR 314.99(b) of the requirement in 21 CFR 314.94(a)(9)(iii) and (iv) that inactive ingredients (specifically pH adjusters) in a generic product be qualitatively (Q1) and quantitatively (Q2) the same as the Reference Listed Drug (RLD), […]