Regulatory and commercial considerations are the primary drivers for successful biosimilar clinical development, according to a new report from 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, Consulting at Quintiles. "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:
- Identify the requisite regulatory stipulations for every market they intend to enter;
- Address the various challenges in clinical development by identifying strategies to accelerate patient recruitment, selecting the right patient population and size to demonstrate similarity to the reference product—as well as to secure extrapolation to additional indications—and incorporating the right clinical endpoints;
- Consider the commercialization strategy early in the development process to account for the variance in uptake of biosimilars, including establishing a concurrent workstream to assess physician and payer willingness to prescribe and pay for the potential biosimilar.
"As the U.S. Food and Drug Administration prepares to issue guidance on biosimilars, we are excited by the potential of biosimilar products to truly improve public health, especially to the extent that they can improve access among patient populations that have not had access to the innovator biologic due to high costs," added Dahal.
The release of the paper coincided with a presentation on Biosimilars Clinical Development - A Five-Year View, by Amar Kureishi, Vice President & Chief Medical Officer - Asia Pacific, at Quintiles. Kureishi gave the presentation at BIO Korea, held in Seoul from September 28-30, where he also participated in a panel during the session on Biosimilar Development and Qualification.
"In the coming five years, we predict that entry hurdles for biosimilars will ease as new regional entrants and established global players begin to enter the market," said Amar Kureishi, Vice President & Chief Medical Officer - Asia Pacific, at Quintiles. "The key question will then be how multiple biosimilars position themselves in the market, how they differentiate themselves from one another, and how prices will be affected. Quintiles has extensive unique experience with biologics and biosimilars; the company helped develop or commercialize 75 percent of the new Biologic License Applications approved 2004 through 2010."