FDA Updates Biosimilar Regulatory Research Program With Roadmap

February 02, 2023

The FDA published its research roadmap as part of the Biosimilars User Fee Act III regulatory research pilot program. The roadmap will allow stakeholders to see how the program will help the FDA enhance regulatory decision-making surrounding biosimilar development.

Biosimilar Rheumatology Roundup: January 2023

February 01, 2023

US Welcomes First Adalimumab Biosimilar, Amjevita

January 31, 2023

BioRationality: A Dr Sarfaraz Niazi Column—FDA Discloses Changes to Drug Review Process, Biosimilar Licensing

January 30, 2023

Seeing Eye to Eye: FDA's Dr Sarah Yim Discusses Efforts to Increase Confidence in Ophthalmology Biosimilars

January 29, 2023

Legal Experts Provide Updates on Biosimilar Patent Disputes in 2022

January 19th 2023

By Skylar Jeremias

Article

Patent litigators from Fish & Richardson, an intellectual property law firm, regaled audiences during a webinar covering all the big biosimilar regulatory and legal decisions throughout 2022, including updates on patent disputes and antitrust investigations.

Study: Denosumab Biosimilar Looks Promising for Osteoporosis in Phase 3 Trial

January 18th 2023

By Justina Petrullo

Article

Researchers found that a denosumab biosimilar appeared comparably safe and effective to reference drug Prolia.

UK Authorizes New Lucentis Biosimilar, Ximluci

January 17th 2023

By Skylar Jeremias

Article

The United Kingdom has approved STADA Arzneimittel and Xbrane Biopharma’s Ximluci, a ranibizumab biosimilar referencing Lucentis, for the treatment of retinal conditions.

Canada Approves Celltrion Bevacizumab Biosimilar

January 17th 2023

By Skylar Jeremias

Article

Health Canada has granted approval for Celltrion Healthcare’s bevacizumab biosimilar (Vegzelma) referencing Avastin for the treatment of multiple forms of cancer.

China's NMPA Approves Tocilizumab Biosimilar

January 16th 2023

By Skylar Jeremias

Article

The China National Medical Products Administration (NMPA) approved Bio-Thera Solutions’ tocilizumab biosimilar (BAT1806) referencing Actemra for the treatment of several rheumatic conditions.

BioRationality: A Dr Sarfaraz Niazi Column—Biosimilar Gene Therapy to Resolve the Most Critical Affordability Issue

January 16th 2023

By Sarfaraz K. Niazi, PhD

Article

In his column, Sarfaraz K. Niazi, PhD, chronicles the potential for biosimilars referencing some of the biggest cell and gene therapies as well as why companies should begin looking into biosimilar development efforts in this space.

Dr Michael Chiang: How the National Eye Institute Is Building Confidence in Ophthalmology Biosimilars

January 15th 2023

By Skylar Jeremias

Article

Michael Chiang, MD, director of the National Eye Institute, discusses how his team is working to instill greater confidence in ophthalmology biosimilars among wary ophthalmologists.

Case Study: Treatment With Adalimumab Biosimilar Resolved Pediatric Scalp, Nail Psoriasis

January 14th 2023

By Deana Ferreri, PhD

Article

A case study outlined a pediatric case of scalp and nail psoriasis, which was successfully treated with an adalimumab biosimilar and monitored with in vivo reflectance confocal microscopy.

The Top 5 Biosimilar Articles for the Week of January 9

January 13th 2023

By Skylar Jeremias

Video

Here are the top 5 biosimilar articles for the week of January 9, 2023.

Study Compares Uptake, Prices of Biosimilars in US vs 2 European Countries

January 12th 2023

By Skylar Jeremias

Article

A study assessing uptake rates and prices of biosimilars found that while the United States had significantly higher prices, the uptake in Germany and Switzerland, 2 European countries with national mechanisms for drug price negotiation, was slower.