News

Biosimilars could improve health system sustainability in Slovakia; however, of the 54 biosimilars approved by the European Medicines Agency as of August 2019, fewer than half are available in Slovakia

Centus’ Equidacent became Europe’s fourth bevacizumab biosimilar to receive marketing authorization.

Over the past decade, savings from biosimilars have grown; however, there remain barriers that prevent biosimilar savings from reaching their full potential, according to a report from the Association for Accessible Medicines.

September saw several biosimilar regulatory advances despite 2020 being a slow year for biosimilar approvals and launches.

The Federal Trade Commission's powers to bring antitrust actions are circumscribed by public versus private and what is vs isn't "reasonable," Markus H. Meier explained.

California has become the first state to implement a policy to produce and distribute its own drug products to help lower costs.

Germany could eke out more gains from biosimilars on top of its already impressive savings, investigators write.

Trial results demonstrated that Innovent Biologics’ bevacizumab biosimilar was effective in combination therapy with a PD-1 inhibitor in patients with hepatocellular carcinoma.

Some acts by companies in the biologics marketplace may go too far in preventing free market activity, according to Markus H. Meier, acting director for the Federal Trade Commission (FTC) Bureau of Competition.

A secretive biosimilars company notches yet another co-licensing deal but withholds full details.

An advance is notched for the ravulizumab (Ultomiris) follow-on product from Alexion. Clinical findings in atypical hemolytic uremic syndrome (aHUS) are provided.

A diverse panel from practice, payer, and wholesale perspectives convened at The American Journal of Managed Care®'s Patient-Centered Oncology Care® 2020 virtual conference to hash out one of the hottest issues in biosimilar availability right now.

Debra Patt, MD, PhD, MBA, discusses issues affecting biosimilar uptake at the Patient-Centered Oncology Care® 2020 virtual conference.

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.

Here are the top 5 biosimilar articles for the week of September 21, 2020.

The NOR-SWITCH study showed comparable safety, efficacy, and immunogenicity for patients with inflammatory bowel disease (IBD) who switched from reference infliximab to Celltrion biosimilar (CT-P13).

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.

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.

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.

Breast cancer specialist Hope S. Rugo, MD, FASCO, an advisory board member for The Center for Biosimilars®, has been at the forefront of groundbreaking oncology advancements.

Lotus and CKD Pharmaceutical intend to be among the first to bring a darbepoetin alpha biosimilar to Southeast Asia.

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.

Here are the top 5 biosimilar articles for the week of September 14, 2020.

Singapore-based PrestigePharma presents fresh equivalency data supporting its case for regulatory approval of HD201.

The American College of Physicians (ACP) said many reforms are needed to install appropriate checks and balances in the biologic drugs marketplace.