News

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.

A recent QuintilesIMS report shows that biosimilars have led to reductions in the price of biologics in Europe. Our infographic shows 4 key takeaways from the study.View the infographic or read more about the report here.

AbbVie has announced positive top-line results from its phase 3 clinical trial evaluating upadacitinib (ABT-494), an investigational janus kinase 1 or JAK1-selective inhibitor.

The US biopharmaceutical industry faces mounting global competition from countries in the developing world and Europe that are increasingly implementing pro-innovation programs and strategies in the sector, according to a new report conducted for the Pharmaceutical Research and Manufacturers of America (PhRMA)

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.

Nevada Governor Brian Sandoval is supportive of bipartisan bill SB 539 after it hones in on both, the pharmaceutical companies and pharmacy benefit managers (PBMs).

Nevada bill SB 265, which would have required pharmaceutical companies that make diabetes drugs to disclose information on insulin pricing, profits, and costs, and to publicly post that information, was vetoed by Nevada Governor Brian Sandoval. Sandovol cited concerns over “nascent, unproven, and disruptive” changes to state healthcare policy.

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comment letter to the FDA on the agency’s Considerations in Demonstrating Interchangeability With a Reference Product draft guidance, calling on the FDA to do more to “promote transparency and patient safety."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 potential cost savings offered by biosimilars may never be realized in the United States if reimbursement incentives are not implemented to ensure their adoption and long-term use, according to industry expert Molly Burich.

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.