Regulatory

A Banner Year for Biosimilars: The 19 FDA Approvals From 2024

January 21st 2025

By Skylar Jeremias

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

FTC Releases Second Report on PBMs Meddling in Generic Drug Markets

January 19th 2025

By Skylar Jeremias

The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.

Improving Biosimilar Access Through Global Regulatory Convergence

January 15th 2025

By Skylar Jeremias

Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.

BioRationality: What’s Wrong With the Indian CDSCO Biosimilar Guidelines?

January 7th 2025

By Sarfaraz K. Niazi, PhD

Senators Introduce Bipartisan Legislation to Protect Skinny Labeling

January 2nd 2025

By Skylar Jeremias

To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.

Cetuximab Biosimilar Receives NMPA Approval for RAS/BRAF Wild-Type CRC

January 1st 2025

By Courtney Flaherty

First-line cetuximab beta injection has received NMPA marketing approval in RAS/BRAF wild-type metastatic colorectal cancer.

Top 5 Most-Read Regulatory Articles of 2024

December 25th 2024

By Skylar Jeremias

In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars referencing ustekinumab, adalimumab, denosumab, and aflibercept, marking key regulatory milestones in improving patient access to cost-effective treatments.

Health Canada Approves First Omalizumab Biosimilar

December 16th 2024

By Skylar Jeremias

Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.

Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration

December 10th 2024

By Skylar Jeremias

Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.

Denosumab Biosimilars Earn Positive CHMP Opinion for Bone Loss and Giant Cell Tumor of Bone

November 26th 2024

By Ashling Wahner

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the denosumab biosimilars SB16 for all indications referencing Prolia and Xgeva.