Regulatory

Legal Experts Weigh in on BPCIA Severability

October 26th 2020

By Tony Hagen

A trio of legal experts discuss Amy Coney Barrett's bid for a Supreme Court seat and how that might affect deliberations on the Affordable Care Act and the Biologics Price Competition and Innovation Act (BPCIA).

Biocon Reports Biosimilars Revenue Growth

October 23rd 2020

By Tony Hagen

Article

Biocon had a busy quarter, which included the launch of a long-acting insulin glargine product (Semglee) in partnership with Mylan.

Biogen, Samsung Report Third-Quarter Biosimilar Results

October 21st 2020

By Tony Hagen

Article

Earnings fell overall for Biogen, although biosimilar revenues continued an upward climb.

Henlius Inks Global Bevacizumab Biosimilar Distribution Deal

October 21st 2020

By Tony Hagen

Article

Shanghai Henlius Biotech will share development and distribution of its bevacizumab biosimilar candidate HLX04 with Zhuhai Essex and Essex Bio-Investment.

Avalere: Step Therapy May Exacerbate Patient, Payer Costs

October 19th 2020

By Tony Hagen

Article

An Avalere analysis suggests costs are more moderate and lower under a no–step therapy scenario for patients with Crohn disease.

Amgen 2020 Biosimilar Report Provides Market Share, ASP Info

October 14th 2020

By Tony Hagen

Article

Amgen's 2020 biosimilar report goes into detail on market share and costs for biosimilars across the therapeutic spectrum in the United States.

Alexion, Celltrion Notch Product Development Gains

October 14th 2020

By Tony Hagen

Article

Alexion and Celltrion separately announce advances in their drug development and marketing efforts.

Interview: Understanding the Attraction for PD-1 Inhibitor Biosimilars

October 13th 2020

By Tony Hagen

Article

Years ahead of patent expirations for programmed death-1 (PD-1) inhibitors, biosimilar companies have begun focusing on these targeted drugs.

Study: Efficacy Trials Cost More, Take Longer for Biosimilars Than Originators

October 10th 2020

By Skylar Jeremias

Article

Average clinical efficacy testing cost millions of dollars more for phase 3 biosimilar studies than for pivotal studies of originator products, authors report.

International Presenters Share Tips on Beefing Up Biosimilar Use

October 9th 2020

By Skylar Jeremias

Article

As the United States continues to struggle to increase biosimilar uptake, presenters at the DIA 2020 Biosimilars Conference offered insight into what other countries have done to encourage biosimilar use.