Pharmaceutica Analytica Acta

Current agency expectations for approval of biosimilars

International Conference on Bio-Pharmaceuticals, Biosimilars & Pharma Industry

February 28 - March 01, 2019 Osaka, Japan

Ravi Kiran

Lupin Limited, India

Posters & Accepted Abstracts: Pharm Anal Acta

Abstract:

The purification of biosimilar for marketing approval, regulatory approval of biosimilars remain a challenge. Demonstrating consistency and inclusion of appropriate information in CTD submissions are the recurring challenges for manufacturers. The main focus on the most common challenges identified in application by regulatory agencies, including EMA and PMDA. Provide an overview of challenges encountered during the assessment of biosimilar marketing application, The common issues raised in downstream process. Control strategy and data quality expectations for creation of the overall process control strategy, and strategic choices taken for final approval. The solutions that were used to address the known challenges, including practical alternative solutions to current approaches in purification of biosimilars. The type of process parameters and performance parameters to be validated in the process performance qualification of purification stages (chromatography, virus inactivation and virus filtration). Agencies may not raise concerns about the safety and efficacy of the product because it is similar and not identical.

Biography :

E-mail: ravikiran.july22@gmail.com