Bioanalytical strategies supporting the successful development of biosimilar candidates are conceptually different from those supporting development of novel, originator products. Differences stem from the unique goals of a biosimilar development program; rather than demonstrating the safety and efficacy of the biosimilar, the objective is to assess and compare the safety and efficacy of the biosimilar to that of the originator. While seemingly trivial at first glance, this difference translates into a burden for the bioanalytical team which requires careful planning and execution to deliver a scientifically sound bioanalytical package.
The past decade has witnessed discussion, debate, and ultimately an evolution in best practice around the bioanalysis of biosimilars. As industry and regulators grappled with the type and extent of data necessary to support the objectives of biosimilar development programs, debate yielded to consensus, and best practices have slowly emerged. Data continue to drive on-going discussion shaping the leaner, more streamlined approaches to developing, validating, and implementing bioanalytical assays used to support biosimilar development programs. But where are we going? What ground will we cover next?
As the market for biosimilars continues to expand, understanding from a bioanalytical perspective where we have been, where we currently stand, and what the future potentially holds will be crucial to success of individual development programs and the broader industry.
Are there strides still to be made in the bioanalytical landscape that can accelerate development and innovation for the benefit of patients and society, alike? What barriers to entry exist that may be limiting the introduction of additional biosimilars to the market?
Also, from a regulatory perspective, what gaps persist in existing regulatory guidance around bioanalysis of biosimilars? How can industry collaborate with regulators to realize opportunities or overcome barriers to growth and increased sustainability of the biosimilar industry?
Participants will gain a deeper understanding of the history, recent trends, and current consensus regarding best practices around bioanalysis of biosimlars.
Upon completion of this session, attendees will be able to better articulate the relationship and importance between a sound bioanalytical strategy and its role in achieving success of a biosimilar development program.
Upon completion, participants will leave with a deeper understanding of the current hurdles limiting efficiency in development and introduction of biosimilars to the marketplace. Participants will be better equipped to critically brainstorm solutions to mitigate these hurdles and drive efficiency in making biosimilar therapeutics available to patients.