Development

Eye on Pharma: New Partnerships; Samsung Adalimumab Updates; Phase 3 Ustekinumab Results

January 22nd 2023

By Skylar Jeremias

Article

Alteogen and Alvotech announce updates for their respective license partnerships; Samsung Bioepis speeds up interchangeability study for its adalimumab biosimilar; Dong-A ST shares positive phase 3 results for its ustekinumab biosimilar.

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.

IQVIA Report Boasts Biosimilar Uptake in Europe, Sheds Light on What’s to Come

January 10th 2023

By Skylar Jeremias

Article

IQVIA’s eighth edition of its Impact of Biosimilar Competition in Europe report demonstrated successful uptake in many countries throughout the region. However, not every country has great adoption rates and companies may have a harder time choosing which molecules to invest in for biosimilar development.

Celltrion Submits BLA for Infliximab Biobetter

January 5th 2023

By Skylar Jeremias

Article

Celltrion Healthcare submitted a biologics license application (BLA) to the FDA for its biobetter of its infliximab biosimilar allowing for subcutaneous administration (Remsima SC).

BioRationality—A Dr. Sarfaraz Niazi Column: Lessons From 2022 Biosimilar Events

January 4th 2023

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, summarizes some of the lessons that the entire biosimilar industry can take away from 2022, including what new legislation and policy changes could mean for future biosimilar development.

Biogen's Ian Henshaw Weighs in on Clinical Efficacy, Switching Studies for Biosimilars

December 28th 2022

By Skylar Jeremias

Video

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, shares his thoughts on whether clinical efficacy and switching studies to establish biosimilar safety are necessary, a hotly debated topic in the biosimilars industry.

John Gabrielson Explains Impact of Clinical Efficacy Tests, Government Policies on Biosimilar Development

December 25th 2022

By Skylar Jeremias

Article

John Gabrielson, senior vice president at JSR Life Sciences and head of Similis Bio, shares his perspective on how clinical efficacy testing and recent actions from the Biden Administration, such as the executive order on biotechnology investment, impact biosimilar development.

Biogen's Ian Henshaw: Why Global Biosimilars Week Is Important for Improving Adoption

December 22nd 2022

By Skylar Jeremias

Video

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, describes the importance of awareness campaigns like the International Generic and Biosimilar Medicines Association's Global Biosimilars Week and how these initiatives can be leveraged to improve biosimilar adoption and acceptance.

BioRationality: A Dr Sarfaraz Niazi Column—The Unmined Treasure of Ignored Biosimilars

December 20th 2022

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, breaks down the current status of biosimilar development and makes suggestions for which molecules manufacturers should target next in his newest column installment.

Study: Liraglutide Biosimilar RD12014 Demonstrates Biosimilarity to Victoza

December 10th 2022

By Deana Ferreri, PhD

Article

A phase 1 study in China found that pharmacokinetics, safety, and immunogenicity were similar between the liraglutide biosimilar RD12014 and the reference product (Victoza) in healthy male participants.