Biosimilar Strategy

As the regulatory landscape continues to evolve for biosimilars, the intriguing challenges for the biosimilar development companies are creating a unique recipe that serves all the requirements from global regulatory authorities. Our SMEs have a deep understanding of the regulatory guidelines and experience/expertise in the domain can help our clients in identifying the “common” needs that serves a majority of regulators, while also identifying a few “unique” fillers that may be required for some regulators.

A systematic biosimilar development plan with proper regulatory strategy can significantly reduce the risk and timeline. We help our clients to come up with an innovative and pragmatic approach for drug development and clinical regulatory strategy for successful establishment of biosimilarity and interchangeability.

• Off-the-shelf scientific and regulatory strategy by molecule 
• FDA 351(k) application process
• Characterization
• Non-clinical study conduct
• Clinical study conduct 
• Interchangeability