September 23rd 2020
By Skylar Jeremias
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.
By Tony Hagen
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 22nd 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.
September 21st 2020
The United States has missed out on almost $20 billion in savings as a result of not having a competitive biosimilar market, according to findings from the Pacific Research Institute.
Lotus and CKD Pharmaceutical intend to be among the first to bring a darbepoetin alpha biosimilar to Southeast Asia.
September 18th 2020
By Deana Ferreri, PhD
Much of the groundwork for establishing equivalence is established in the pharmacokinetic evaluation. Further studies add less and less to the body of evidence for biosimilar approval, UK regulators write.
Celltrion moves another step forward in its bid to get a coronavirus disease 2019 (COVID-19) treatment on the market.
September 17th 2020
Singapore-based PrestigePharma presents fresh equivalency data supporting its case for regulatory approval of HD201.
