Regulatory

President Trump Signs Executive Order to Bring Down Drug Prices

April 16th 2025

By Skylar Jeremias

To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.

How State Substitution Laws Shape Insulin Biosimilar Adoption

April 15th 2025

By Skylar Jeremias

Article

States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.

Experts Pressure Congress to Remove Roadblocks for Biosimilars

April 12th 2025

By Skylar Jeremias

Article

Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.

FDA Approves Biocon Biologics' Bevacizumab Biosimilar

April 10th 2025

By Skylar Jeremias

Article

Biocon Biologics expands its oncology biosimilar roster after gaining FDA approval for Jobevne (bevacizumab-nwgd), the sixth biosimilar referencing Avastin (bevacizumab).

Review Calls for Path to Global Harmonization of Biosimilar Development Regulations

March 17th 2025

By Skylar Jeremias

Article

Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.

FDA Approves First Omalizumab Biosimilar

March 7th 2025

By Skylar Jeremias

Article

Celltrion's Omlyclo (omalizumab-igec) is the first omalizumab biosimilar to be approved for US patients, and it was approved with interchangeability, making it easier for patients to switch to the Xolair competitor.

From Amjevita to Zarxio: A Decade of US Biosimilar Approvals

March 6th 2025

By Skylar Jeremias

Article

Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.

FDA Approves Third Pair of Denosumab Biosimilars

March 4th 2025

By Skylar Jeremias

Article

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

Biosimilars Regulatory Roundup: February 2025

March 1st 2025

By Rose McNulty

Article

February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart biosimilar.

Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements

February 25th 2025

By Cameron Santoro

Article

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.