Regulatory

Republican Nevada Governor Brian Sandoval yesterday signed into law the country’s strictest requirements for drug companies to show how they set prices for certain prescription drugs, with a specific focus on insulin.

News of the landmark Supreme Court ruling in the case of Sandoz v Amgen broke during the Monday session of the 8th Annual Summit on Biosimilars, a meeting of legal and pharmaceutical industry professionals convened in New York City. In a previously scheduled—and swiftly updated—discussion of the case, a panel of attorneys grappled with the ruling and its implications for the industry.

Last week, Amgen and Allergan announced that the FDA will review data supporting the firms' Biologics License Application for ABP 215, a bevacizumab (Avastin) biosimilar candidate.

Coherus BioSciences announced that it has been issued a complete response letter by the FDA in response to its biologics license application for CHS-1701, a pegfilgrastim biosimilar candidate.

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comment letter to the FDA on the agency’s Considerations in Demonstrating Interchangeability With a Reference Product draft guidance, calling on the FDA to do more to “promote transparency and patient safety."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.