News

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.

Many patients with rheumatic diseases are unsure whether their prescriptions are biosimilars, suggesting more efforts in patient education are needed.

A broader range of indications in rheumatology combined with a Canadian push for biosimilar acceptance bodes well for Merck's Brenzys product.

Courts have allowed biosimilar developers "safe harbor" against infringement suits, but there are limits, attorneys from Goodwin Proctor explain.

Representative Glenn Grothman, R-Wisconsin, says interchangeability for insulins makes sense based on the savings potential and safety record of these agents.

Positive results emerging on oncology biosimilars will be presented at the European Society for Medical Oncology Virtual Congress 2020 this week .

With anti–tumor necrosis factor (TNF) therapy showing promise in treating coronavirus disease 2019 (COVID-19), authors called for these agents to have a higher priority in research.

Samsung Bioepis' bevacizumab biosimilar demonstrates equivalence in analyses to be presented at the European Society for Medical Oncology Virtual Congress 2020.

Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.

In the effort to find treatments for coronavirus disease 2019 (COVID-19) and related conditions, Celltrion Healthcare’s monoclonal antibody has shown promise in a phase 1 trial.

Trade associations and companies in the biosimilars business ask the FDA to hone its proposed study on product disclosures.

Here are the top 5 biosimilar articles for the week of September 7, 2020.

Product differentiation via oral formulations of biologics could be the next battleground between originators and biosimilar companies.

Oral biologics would offer many advantages over injectable drugs, and some companies believe they are on the cusp of making this happen.