Key considerations for successful biosimilar development viewed by Quintiles

Regulatory and commercial considerations are the primary drivers for successful biosimilar clinical development, according to a new report from biopharmaceutical services company Quintiles, titled An Integrated Approach to Biosimilar Development & Commercialization. In addition, the report states that successful biosimilar companies will be those who collapse their clinical, commercial, and regulatory thinking into a streamlined cohesive function as they proceed with developing biosimilars.

“The biosimilar market is expected to grow significantly, creating an enormous opportunity for biopharmaceutical companies,” said the paper’s lead author, Deepa Dahal, principal consultant, commercial strategy at Quintiles, adding: “Yet, biosimilar development is a uniquely difficult endeavor. Successful development and commercialization require a business strategy that integrates a regulatory strategic roadmap, commercial and market access considerations, and appropriate clinical strategy and trial design. And this strategy must be put into place in the very early stages of any biosimilar development program.”

According to the report, companies seeking entry into - or a sustained position within - the biosimilars marketplace, must: