Regulatory

Industry Group Representative Discusses Biosimilars in Michigan

January 19th 2022

By Tony Hagen

Bret Jackson, president of the Economic Alliance for Michigan, notes that Ford Motor is a biosimilar success story, having saved a significant amount of money on just a handful of drugs.

Real-world Study Sees Adoption of Mvasi by US Oncologists for Metastatic CRC

January 18th 2022

By Deana Ferreri, PhD

Article

Records show the biosimilar for bevacizumab was used to treat both new patients and those already receiving care with the reference product.

Pharmacokinetic and Pharmacodynamic Equivalence of Biocon’s Proposed Biosimilar Insulin-R to Humulin-R

January 17th 2022

By Deana Ferreri, PhD

Article

Insulin costs have increased dramatically in recent years, and the study authors note that high costs for many patients result in nonadherence or insulin rationing, leading to diabetic complications and even death.

Wayne Winegarden, PhD, Discusses Which Insurance Type He Expects Will Have the Greatest Biosimilar Savings

January 16th 2022

By Skylar Jeremias

Video

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, shared his thoughts on which coverage type he expects will have the most robust biosimilar savings: Medicare, commercial, or military.

International Biosimilars Trade Group Appoints New Leadership for 2022

January 15th 2022

By Tony Hagen

Article

The International Generic and Biosimilar Medicines Association has appointed a veteran member, Vivian Frittelli, MBA, ACIS, to take over as chair.

Amgen CEO Touts Potential for Doubling in Biosimilar Revenue

January 11th 2022

By Tony Hagen

Article

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.

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In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.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