The Pharma Data
JUNE 17, 2022
Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe.
The Pharma Data
JUNE 7, 2022
New Indication for Amgen’s Fifth FDA-approved Biosimilar. “Our fully integrated portfolio of innovative and biosimilar medicines for inflammatory diseases reinforces our commitment to providing patients with high-quality and affordable treatment options that deliver substantial value to our healthcare system.”
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Agency IQ
JULY 26, 2024
FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.
The Pharma Data
FEBRUARY 25, 2022
Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An
FDA Law Blog: Drug Discovery
FEBRUARY 2, 2023
As to biosimilars, FDORA amends the statutory language regarding criteria for the demonstration of biosimilarity for a 351(k) biologic. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. § 262(k)(2)(A)(i)(I). 42 U.S.C. § 262(k)(2)(A)(i)(I). FDORA § 3209(b).
The Pharma Data
DECEMBER 13, 2020
Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Amgen has a target action date of December 19 for its BLA for ABP 798, a biosimilar to Genentech’s Rituxan (rituximab). The biosimilar is a collaboration between Amgen and Allergan, which was formed when Allergan was Watson Pharmaceuticals in December 2011.
The Pharma Data
APRIL 4, 2023
Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.
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