Kelly Davio

June 13, 2017

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.

June 12, 2017

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.

June 10, 2017

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.

June 09, 2017

A study presented at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) found that there was no clinically meaningful difference when patients with breast cancer were switched from treatment with reference filgrastim (Neupogen) to EP2006, the first FDA-approved filgrastim biosimilar (marketed as Zarxio).

June 08, 2017

Research presented at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) shows that CT-P6, a proposed trastuzumab biosimilar, is safe and effective as a neoadjuvant treatment in HER2–positive early breast cancer.

June 06, 2017

A study at ASCO 2017 demonstrates that SB3, a proposed biosimilar to trastuzumab (Herceptin) has comparable efficacy and safety to the reference product based on the breast pathological complete response.

June 06, 2017

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comment letter to the FDA on the agency’s Considerations in Demonstrating Interchangeability With a Reference Product draft guidance, calling on the FDA to do more to “promote transparency and patient safety."

June 06, 2017

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.

June 02, 2017

Research presented at the 22nd Annual International Meeting of The International Society for Pharmacoeconomics and Outcomes Research demonstrates gaps in physicians’ education on biosimilar agents.

June 01, 2017

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.