Regulatory

In a big win for Sandoz, the US Supreme Court ruled today that a manufacturer of a biosimilar product can provide a notice of commercial marketing either before or after FDA approval of the drug to the reference product developer.

On June 7, The Atlantic hosted a Policy Update on Biosimilars sponsored by The Biosimilars Council (Association for Accessible Medicines) as part of the publication’s “The Next Drug” series.

Today, the European Medicines Agency (EMA) released its June 2017 list of medicines currently under evaluation, and many of the biosimilars are also under consideration by the FDA.

FDA Commissioner Scott Gottlieb, MD, said that the agency is examining how to push drug applications to “the front of the line” when there are fewer than 3 competing manufacturers for generic versions of a particular medication.

The Biologics Prescribers Collaborative (BPC), an organization comprising 6 member groups whose memberships prescribe biologic agents, has released its comment letter to the FDA on the agency’s Considerations in Demonstrating Interchangeability With a Reference Product draft guidance, calling on the FDA to do more to “promote transparency and patient safety."

In a new paper published in Cancer Care Management and Research, researchers examine the progress that the United States has made toward reforming healthcare since the passage of the Affordable Care Act (ACA) in 2010, with a particular focus on the role that biosimilar products may play in achieving the ACA’s 3-fold goal of increasing access to treatment, controlling costs, and improving patient care.

The ongoing district court litigation of Amgen v Hospira—a case regarding Hospira’s proposed biosimilar to epoetin alfa (Epogen), a biological agent used to treat anemia—progressed on May 26, 2017, when counsel for Amgen filed a motion for a preliminary injunction.