Biosimilars Poll: Which Way Will the Supreme Court Rule on the ACA?

The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to establish a demonstration project within Medicare that would establish a shared savings model for biosimilars, was introduced to the House of Representatives.

The Supreme Court’s ruling in the Affordable Care Act (ACA) case appears to have saved the biosimilars approval pathway, but do the plaintiffs have other avenues by which to bring another challenge?

Patent litigators from Fish & Richardson, an intellectual property law firm, regaled audiences during a webinar covering all the big biosimilar regulatory and legal decisions throughout 2022, including updates on patent disputes and antitrust investigations.

Key 2020-2021 updates to the Guide to Biosimilars litigation and Regulation in the US encompass antitrust litigation, preliminary injunctions, and a slowdown in litigation.

The Biosimilar Red Tape Elimination Act will seek to increase patient access to biosimilars by reducing switching study requirements for companies to obtain interchangeability designations.

As the US awaits the 2023 launch of adalimumab biosimilars, Biogen announces an injunction against Sandoz over a natalizumab biosimilar, Rani Therapeutics initiates a development program for an oral ustekinumab biosimilar, and Bio-Thera Solutions begins a phase 3 trial for a secukinumab biosimilar.