Regulatory

October 12th 2026

Bipartisan bills would automatically delay Medicare price talks for biologics facing biosimilars as California expands substitution.

October 8th 2026

Teva's Robert Cook, PhD, explains the clinical data, interchangeability, and supply strategy behind its Degevma and Ponlimsi biosimilars.

August 19th 2026

An editorial modeled on Hatch-Waxman proposes an abbreviated FDA pathway granting biosimilars class-level interchangeability to spur competition.

August 6th 2026

Analytical characterization supports monoclonal antibody biosimilar approvals and may reduce clinical testing needs, researchers found.