September 26, 2020
Tony Hagen
An advance is notched for the ravulizumab (Ultomiris) follow-on product from Alexion. Clinical findings in atypical hemolytic uremic syndrome (aHUS) are provided.
September 25, 2020
Debra Patt, MD, PhD, MBA, discusses issues affecting biosimilar uptake at the Patient-Centered Oncology Care® 2020 virtual conference.
Skylar Jeremias
Despite concerns over whether importing drugs from Canada would be safe for patients or effective at lowering drug costs, the FDA has moved forward with implementing the policy.
September 24, 2020
The International Generic and Biosimilar Medicines Association (IGBA) seeks to limit the use of comparative clinical efficacy studies to support biosimilar equivalency applications.
Two bills in Congress meant to address the anticompetitive practice of product hopping drew fire at the American Conference Institute's annual biosimilars conference.
September 23, 2020
Much emphasis is placed on the value of congressional action to reduce prescription costs, but the Center for American Progress suggests there is an existing toolkit to accomplish this objective.
The FDA's Office of Therapeutic Biologics and Biosimilars balances a large number of biosimilar development projects with limited resources and is making progress, says Eva Temkin, acting director of policy.
Panelists at American Conference Institute's (ACI) 2020 virtual summit discuss California's legislative attempts to improve competition in the drug industry.
September 22, 2020
Biosimilars from Samsung Bioepis have demonstrated equivalency in clinical trial and real world settings, according to 2 prominent cancer specialists.
The Committee for Medicinal Products for Human Use (CHMP) recommendation for ravulizumab (Ultomiris) is for a dosage that involves a less rigorous schedule for administration.
