Biosimilars Forum Scientific Publication Identifies Pathway To Streamlined Development For Biosimilars

A new peer-reviewed scientific publication from the Biosimilars Forum provides a comprehensive set of recommendations on how biosimilar development should evolve. The recommendations reflect current science and available evidence. These efficiencies will enable patients to access more and a wider variety of biological drugs – without impacting safety or effectiveness.

The manuscript, entitled “Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective,” was published in BioDrugs on August 5, 2023. The recommendations come directly from manufacturers that have developed biosimilars for more than 20 years.

“This landmark publication reflects the collective expertise from biosimilar developers on how biosimilar development should evolve in the future to be more efficient while maintaining the highest global standards to safety, quality and efficacy,” said Hillel Cohen, Co-Chair of the Biosimilars Forum Science and Education Committee and Executive Director of Scientific Affairs at Sandoz. “The proposed efficiencies for future biosimilar development are supported by the proven science and global experience that we have gained about the safety and efficacy of biosimilars.”

The authors of the manuscript are:

• Hillel Cohen, Co-Chair of the Biosimilars Forum Science and Education Committee and Executive Director of Scientific Affairs at Sandoz
• Matthew Turner, Senior Director Government Affairs Global Biosimilars at Fresenius Kabi
• Dorothy McCabe, Co-Chair of the Biosimilars Forum Science and Education Committee and Executive Director of Specialty Pharmaceuticals Clinical Development & Medical Affairs for Immunology and Biosimilars at Boehringer Ingelheim
• Gillian Woollett, Vice President of Regulatory Strategy and Policy at Samsung Bioepis

“A typical biosimilar can cost $100 million to $300 million to develop and the process can take six to nine years to complete,” said Juliana M. Reed, Executive Director of the Biosimilars Forum. “The industry, regulators and lawmakers must work together to create a long-term sustainable biosimilar market that will allow developers to make life-saving treatments more readily available to the patients that need them.”

The published manuscript identifies the following opportunities to evolve development to expand access without compromising the quality, safety and efficacy of biologics or biosimilars:

• Eliminate a routine requirement for a comparative clinical efficacy study
• Utilize a risk-based approach for immunogenicity testing
• Modify US designation of interchangeability immediately and eliminate it in the future
• Eliminate the requirement for comparative pharmacokinetic testing of E.U. and U.S. reference products
• Develop science-based regulatory consistency, including product quality and pharmacovigilance
• Utilize real-world data and real-world evidence

Funding for this project was provided by the Biosimilars Forum.

For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit biosimilarsforum.org.