Kelly Davio

June 01, 2018

On Friday morning in Chicago, Illinois, The Atlantic hosted a series of panels, moderated by Steve Clemons, on the role biosimilars in cancer care. Opening the morning’s proceedings were Gary Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, and Chadi Nabhan, MD, MBA, FACP, CMO of Cardinal Health Specialty Solutions.

June 01, 2018

Two biosimilar developers today announced that they have received positive opinions for products from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

May 31, 2018

FDA Commissioner Scott Gottlieb, MD, on Thursday announced new draft guidance documents aimed at limiting the potential for drug makers to abuse Risk Evaluation and Mitigation Strategy (REMS) requirements. The announcement comes on the heels of President Donald Trump’s drug pricing plan, which called on the agency to issue guidance on how manufacturers use REMS programs to delay competition from follow-on products.

May 31, 2018

Boehringer Ingelheim’s (BI) adalimumab biosimilar, Cyltezo, can be successfully self-administered—via auto-injector—by most patients with rheumatoid arthritis (RA).

May 30, 2018

This week, the European Commission proposed a “recalibration” of Supplementary Protection Certificates (SPCs) to boost investment in the development and manufacture of biosimilars and generics.

May 29, 2018

In a new paper, researchers sought to describe how much the European Union is overspending on neovascular age-related macular degeneration treatment by relying on ranibizumab and aflibercept rather than bevacizumab in ophthalmology.

May 28, 2018

While rituximab is frequently used off-label to treat relapsing-remitting multiple sclerosis (MS), emerging evidence suggests that patients with progressive MS may also benefit from treatment with rituximab.

May 25, 2018

This week, Drugs published a letter to the editor concerning a systematic literature review that showed a low risk of safety concerns or loss of efficacy after switching from a reference biologic product to a biosimilar. The letter’s authors said that switching is a beneficial topic for exploration but criticized the review for “over-interpretation of the available data.”

May 24, 2018

As the United States lags behind Europe and other highly regulated areas in terms of biosimilar approval and uptake, research presented during the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting in Baltimore, Maryland, points to slow market entry and small price discounts of approved biosimilar products as key factors that are holding up cost savings in the US market.

May 24, 2018

At the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting, in Baltimore, Maryland, members of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) discussed the ways in which their organization, a not-for-profit entity that conducts postmarketing observational research to monitor biosimilars and novel biologics for efficacy and safety, is working to provide real-world evidence on these products to stakeholders.