Tony Hagen

June 26, 2020

New prediction methodology for calculating biosimilar application fees will help the FDA cover its costs and respond quickly to changes in demand, officials said at a public meeting.

June 26, 2020

Republican opponents of the Affordable Care Act (ACA), led by the state of Texas, fired opening salvos in the Supreme Court case over the landmark law's constitutionality. If the entire law is thrown out, approval for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) would disappear, too.

June 20, 2020

There is much inconsistency in the way physicians transition patients from insulin degludec to insulin glargine upon hospital admission, leading to higher risk especially for patients with type 1 diabetes, according to a study presented at the American Diabetes Association 80th Scientific Sessions online conference.

June 19, 2020

HLX04, a bevacizumab biosimilar candidate targeted at the colorectal and non–small cell lung cancer markets, met a phase 3 study primary end point, Shanghai Henlius Biotech said.

June 18, 2020

Eli Lilly gets FDA approval for a new formulation of insulin lispro and offers it at the out-of-pocket cap of $35 for a monthly supply for patients with or without insurance.

June 17, 2020

Studies on switching and retention for adalimumab and etanercept biosimilars yielded positive data, according to abstracts presented at the EULAR 2020 Congress.

June 17, 2020

A study presented at the European League Against Rheumatism conference suggested that French rheumatologists have good knowledge of biosimilars but lack the confidence to use them.

June 16, 2020

A rituximab biosimilar developed by Celltrion Healthcare demonstrates safety and efficacy in patients with relapsed or refractory aggressive B-cell lymphoma, in findings presented at EHA25 Virtual, the annual meeting of the European Hematology Association.

June 15, 2020

The infliximab biosimilar CT-P13 delivered positive results in studies presented at the European League Against Rheumatism's European E-Congress of Rheumatology 2020.

June 15, 2020

Lannett’s insulin glargine biosimilar candidate will break new ground as it moves through the 351(k) review pathway, according to Ha Kung Wong, an intellectual property law attorney with Venable of New York.