Kelly Davio

As patients, policy makers, and providers alike wait to learn the fate of the contentious new Senate healthcare bill, some stakeholders suggest that existing legislation—dating back to the 1980s—could potentially play a role in driving down prescription drug costs.

A recent study presented at EULAR found that a substantial number of patients who switched treatment from reference etanercept to a biosimilar switched back to the reference after a short period.

After negotiations with drug manufacturer Roche, England’s National Health Service (NHS) has approved the routine use of trastuzumab emtansine (Kadcyla) for the treatment of HER2-positive metastatic breast cancer in patients for whom trastuzumab (Herceptin) treatment has failed.

At the 8th Annual Summit on Biosimilars, a panel of legal experts reviewed lessons learned from the first 18 months of biosimilars in the United States, and looked ahead to the question of how these drugs will gain acceptance and market uptake.

In a recent study, researchers sought to investigate the clinical impact of 1-year certolizumab pegol therapy added to the first year of a 2-year treatment with methotrexate in patients with early rheumatoid arthritis.

Denmark is the first nation in Europe—and in the world—to switch all well-treated rheumatoid arthritis patients from reference infliximab (Remicade) to the biosimilar Remsima, and 1 early study suggests that the switch has been successful. Patients, however, have needed convincing.

Sandoz announced today that its biosimilar rituximab product has been approved by the European Commission to treat blood cancers and immunological diseases.

Lawmakers are contemplating a substantial range of reforms to make biologics more affordable for patients.

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.

In order to investigate the best morning insulin therapy to improve glycemic variability in patients with type 2 diabetes, researchers from Japan compared morning injections of insulin glulisine and insulin glargine with injections of insulin lispro and insulin glargine biosimilar.

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.

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.

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.

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).

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.

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.

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.

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.

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.

In a study presented at the 22nd Annual International Meeting of The International Society for Pharmacoeconomics and Outcomes Research, researchers sought to identify physicians’ documented granulocyte colony-stimulating factor (G-CSF) use, with a particular focus on filgrastim-sndz since its entry into the marketplace, and identified a slow US uptake for the biosimilar.