Policy

BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars

April 21st 2025

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.

President Trump Signs Executive Order to Bring Down Drug Prices

April 16th 2025

By Skylar Jeremias

Article

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).

BioRationality: Commemorating the 15th Anniversary of the BPCIA

April 8th 2025

By Sarfaraz K. Niazi, PhD

Article

Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.

Adalimumab Biosimilars Show Similar Outcomes in Psoriasis After Nonmedical Switch

March 26th 2025

By Skylar Jeremias

Article

Switching between adalimumab products does not affect drug effectiveness or treatment duration in patients who have psoriasis, according to a Danish study.

Smart Tendering Policies Unlock Greater Biosimilar Savings

March 20th 2025

By Skylar Jeremias

Article

Tendering emerged as the most effective strategy for reducing costs and increasing biosimilar uptake in the retail setting, while price-linked discounts and prescribing quotas have shown mixed or uncertain results.

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.