How Can You Ensure Successful Late-Phase Development and Launch of Your Biologic Drug Product?

Biologics, which are expected to account for over half of all innovative drug sales by 2027, offer exciting opportunities to a growing pharmaceutical industry, especially when considering their low attrition compared to that of small molecule drugs. Even so, only around 15% of Phase 1 molecules are expected to reach commercialization, with the other 85% of investments not expected to be recoverable.¹ Therefore, it is important to consider several factors in the overall development approach during the early phases in order to de-risk late-phase development. Not doing so could lead to limited product knowledge, ultimately compromising the overall timeline to a successful market authorization submission.