Submitted by Lynne LaSauteur
On Sunday morning, March 10, 2013, at the SOT 52nd Annual Meeting in San Antonio, Texas, Lynne LeSauteur (Charles River) and Jonathan D. Urban (ToxStrategies Inc.) chaired a Continuing Education (CE) course entitled “Approval of Biosimilar Monoclonal Antibodies: Scientific, Regulatory, and Legal Challenges." While established standard analytical methodologies enable manufacturers of generic small molecule drugs to demonstrate pharmaceutical equivalence, the complex and sensitive nature of even the most similar biologic manufacturing systems makes producing identical copies of the innovative monoclonal antibody products impossible.
This CE course successfully integrated case studies to compare and contrast the scientific and regulatory approaches used for mAb biosimilar drug development in addition to an overview of global biosimilar guidelines by Barbara Mounho-Zamora (ToxStrategies Inc.) as well as instruction on the Biologics Price Competition and Innovation Act and the role of patent and data exclusivity provisions by Kimberly Greco (Amgen).
Christine Grimaldi (Boehringer-Ingelheim) presented analytical preclinical strategies to support clinical development of biosimilar monoclonal antibodies. This presentation emphasized the aims of preclinical biosimilar mAb programs that include establishing similarity of key quality attributes with reference originator product, applying a stepwise approach (e.g., in vitro studies done prior to in vivo studies), studies designed to identify potential differences of relevance, establishing immunogenicity, and enabling clinical trials. Danuta J. Herzyk (Merck) presented a case study describing the toxicological evaluation of a biosimilar to anti-CD20 mAb, and Michael W. Leach (Pfizer) provided a comprehensive summary of the development strategies of four additional biosimilar mAbs. Marjorie Shapiro (US Food and Drug Administration) ended the session with an overview of the regulatory considerations for biosimilar monoclonal antibodies by outlining the approved mAbs and Fc-fusion proteins, the definition of biosimilarity, and analytical evaluation of protein products. She also provided a regulatory understanding of the process to produce product with consistent quality attributes.
Given the interest in this field and the development of biosimilars by several companies worldwide and the changing regulatory guidelines, this session generated a lot of interest and thought with regards to the development of biosimilar mAbs.
For a preview of the Continuing Education courses that will be held at the 2014 SOT 53rd Annual Meeting, please visit the SOT Annual Meeting website.