What you need to know about getting Biosimilars to market
It’s official. The FDA has acknowledged a biosimilar logjam in the US; Although FDA has approved 11 biosimilars, only three have reached the market and none are performing well commercially.
In July, Scott Gottlieb, FDA’s Commissioner, unveiled his Biosimilar Action Plan. Among other points, he wants to improve the efficiency of the biosimilar and interchangeable product development and approval process. This is good news for sponsors and patients of biosimilars as it indicates that the current draft of US FDA biosimilar guidance will be relaxed regarding interchangeability standards.
But today, it is still business as usual for sponsors of biosimilars wishing to break into the US market who are still in the R&D phase of drug development. Speed is still critical and one of the biggest hurdles remains finding the right patients as quickly as possible. But while the problem is old, the solutions are new. Human data science – the integration of advances in technology and data science, with real-world insights and targeted domain and regulatory expertise - is opening up a new way for companies to not only find and recruit patient, but also develop more creative ways to jump over long-frustrating barriers, from optimizing country mix to minimizing risks to quality and protocol amendments.
Of course finding patients is just the beginning - potential patients are less willing to enroll in biosimilar trials where the products are fully or mostly reimbursed (e.g., US and Big 5 EU), and competition seems to come from all sides – from other biosimilar sponsors to new chemical entity (NCE) drug developers. A classic example is trying to obtain enough patients with NSCLC for the Phase III bevacizumab biosimilar trials: The target patient number can be greater than 600, and competition includes sponsors of trials investigating PDL1s to treat the same patient population.
Learn more about how IQVIA’s Biosimilars Center of Excellence is using the IQVIA CORE to bring the potential of human data science to customers in, or approaching, the biosimilar logjam, and deliver the next generation of clinical development capabilities.
And to read more about the team’s perspective on innovative approaches to expediting development in biosimilars, read their latest paper in Regulatory Focus.
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