Development

Amgen CEO Touts Potential for Doubling in Biosimilar Revenue

January 11th 2022

By Tony Hagen

Amgen Chairman and CEO Robert Bradway touted the potential of 11 biosimilars anticipated to be driving revenues for the company by 2030.

Developers Advised to Challenge Regulatory Standards to Speed Development of Biosimilars

January 11th 2022

By Meir Rinde, MS

Article

In a recent paper, Sarfaraz K. Niazi, PhD summarizes some of his central ideas on the relevance of FDA biosimilar testing standards.

Canada Clears Alvotech Adalimumab Biosimilar for Launch

January 10th 2022

By Tony Hagen

Article

Simlandi (AVT02) is the second high-concentration, citrate-free adalimumab (Humira) biosimilar to be approved in the Canada market.

Wayne Winegarden, PhD, Discusses His Predictions for Etanercept, Adalimumab Biosimilar Pricing Discounts

January 9th 2022

By Skylar Jeremias

Video

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, discusses his predictions for etanercept and adalimumab biosimilar pricing and why he hopes manufacturers will offer them at large discounts to reference biologics.

In India, Patient Advocates Lobby for Modernized Biosimilar Development Standards

January 8th 2022

By Tony Hagen

Article

In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.

Review: Biobetters and Biosimilars Set to Emerge in Ophthalmology

January 6th 2022

By Tony Hagen

Article

Biobetters may gain an edge on reference products, and multiple biosimilars are under development for ophthalmic disorders, the authors write.

Study: Epoetin Alfa Biosimilar Candidate Equivalent to Epogen

January 5th 2022

By Deana Ferreri, PhD

Article

A comparative study of PanGen Biotech’s epoetin alfa biosimilar candidate PDA10 and the reference product, Retacrit, demonstrated comparable efficacy and safety.

Bevacizumab Biosimilar Candidate Demonstrates High Similarity to Avastin in NSCLC

January 3rd 2022

By Deana Ferreri, PhD

Article

Patients with stage IV nonsquamous non–small cell lung cancer (NSCLC) demonstrated equivalent outcomes when treated with MYL-1402O or Avastin.

Report: Biosimilar Competition in Europe

January 1st 2022

By Tony Hagen

Article

Biosimilars have produced more than $20 billion of savings in Europe, but more use of these agents is needed.

The Top 5 Biosimilars Legal Stories of 2021

December 31st 2021

By Tony Hagen

Article

The top legal stories in biosimilars over the past year concerned etanercept and adalimumab biosimilars and access to insulin.