By Sambit Kar
Biologics are complex molecules and as such, prone to multiple forms of degradations that can be triggered by changes in the manufacturing process, thereby compromising the safety, purity, and efficacy of the product. A biologics product therefore can be defined by its manufacturing process. It is the responsibility of the sponsor during regulatory submission to prepare an adequate comparability package to establish the consistency of the product from pre-change to the post-change process to ensure a positive outcome.
The outcome of analytical comparability studies is crucial for progression, regulatory success, and commercial approval. A comprehensive demonstration of analytical comparability and detailed characterization may eliminate the need for additional preclinical and clinical studies, thereby reducing time and cost of development. Successful demonstration of analytical comparability calls for the application of cutting-edge technologies to execute a well thought-out strategy in line with current and global regulatory guidelines.
A related exercise is demonstration of biosimilarity for biosimilar development where the novel tools will be needed to characterize and compare the biosimilar candidate with the innovator product. An extensive data package (PDF) is expected from the regulatory authorities to demonstrate that the candidate biosimilar “has a highly similar quality profile when compared to the reference medicinal product. This should include comprehensive analyses of the proposed biosimilar and reference medicinal product using sensitive and orthogonal methods to determine not only similarities but also potential differences in quality attributes.” Equivalent efficacy, in demonstrating similarity, of two medicinal products requires (PDF) that the biosimilar has no better or no worse efficacy “and any observed differences are of no clinical relevance.”
Kelvin Bai, Ph.D., and I are very excited to let you know that we will be chairing the open forum Characterization and Comparability of Biotherapeutics and Biosimilars—Value of Current State of the Art in Analytical, Biophysical and Mass Spectrometric Methods on June 10 from 6:30 pm to 10:00 pm PST at the upcoming 2015 AAPS National Biotechnology Conference in San Francisco.
The first speaker, Brenda Huneycutt (Avalere Health), will give an in-depth view of the successful approval of the first biosimilar in the U.S. She will share Avalere’s insight gained on regulatory strategy from the FDA Advisory Committee on filgrastim.
Following that, presentations by Kimberly Duffy (Merck) and Tapan Das (Bristol-Myers Squibb) will range from case studies on Biologic License Application packages for multiple asset types (vaccines, antibodies, and other modalities), illustrating regulatory perspectives of big pharma. The tenor of the presentation will then shift more towards cutting-edge technical presentations by James Carroll (Pfizer) and George Bou-Assaf (Biogen Idec), on mass spectrometry as a development tool in antibody-drug conjugates and case studies of how the latest biophysical tools are being used for characterization of biotherapeutics, respectively.
Finally, we will get to hear the perspectives of the FDA, represented by Maria Gutierrez, when she presents key observations and recommendations from recent regulatory submissions.
We invite you to take this opportunity to participate in this forum, which will offer comprehensive coverage of relevant issues and challenges faced by the pharma industry today. The width and depth of the topics will clearly demonstrate how comparability exercises form one the pillars of developmental and regulatory success.
The registration fee includes dinner, which will be ready at the start so that we can get our food, grab a seat, and enjoy the great talks. Bon appétit!
Note: The views contained in this blog represent my own personal opinions, and not of Bristol-Myers Squibb. For information on regulatory approval of medicine in the USA, please visit the U.S. FDA website at www.fda.gov.