PDA Letter Article

Getting Biosimilars Right the First Time

by Barbara Rellahan, Amgen


Biosimilar products represent a rapidly growing sector of the biotechnology market. They have the potential to reduce the cost of biologics, resulting in expanded access to these critical therapeutics.

While a regulatory pathway has been available for biosimilars since 2005 in Europe and since 2010 in the United States, manufacturers still experience challenges when commercializing biosimilars. These include demonstration of analytical similarity to reference product, development of robust manufacturing/control processes and submission of high-quality registration submissions.

The 2018 PDA Biosimilars Workshop will facilitate discussion between global regulatory and industry representatives on these challenges. The workshop aims to provide attendees with strategies on how to address them effectively. The one-and-a- half-day workshop will be co-chaired by Emanuela Lacana, Associate Director for Biosimilar and Biologics Policy, U.S. FDA, and Stephan Krause, PhD, Director, QA Technology, AstraZeneca Biologics.

Krause will kick-off the workshop by moderating an afternoon session on global regulatory expectations for marketing applications. As the number of biosimilar registration submissions increase, regulators are finding common gaps in the CMC sections. Representatives from three regulatory agencies—both U.S. and non-U.S.—will highlight areas where they have observed deficiencies and present agency expectations of what constitutes a high-quality biosimilar registration submission.

Starting off Day 2, Joel T. Welsh, PhD, Review Chief, Office of Biotechnology Products, FDA, will moderate a session on how to navigate technical concerns in biosimilar development. Session speakers will explore methods to avoid pitfalls frequently encountered during biosimilar candidate development. An FDA representative will discuss data quality expectations, including expectations for developing “fit for purpose” analytical methods and inspections. Industry representatives will cover development of an integrated control strategy, the relationship between biosimilarity and process/product control, and the critical strategic decisions during biosimilar development that can influence the quality of the biosimilar and robustness of the biosimilar process.

Bev Ingram, PhD, Senior Director, Pfizer, will moderate the closing session, addressing the role of statistical tools in demonstrating analytical similarity. Here, presentations will highlight practical challenges that arise when applying statistical tools, including reference product variability and Tier 1 attribute expectations as outlined in the FDA draft guidance, Statistical Approaches to Evaluate Analytical Similarity. Practical alternative solutions to current approaches will also be discussed. Experiences from regulatory agencies outside the United States will be shared to complement the details presented in the FDA draft guideline.

By participating in this workshop, biosimilar product developers can better understand the common issues experienced by multiple regulatory authorities when reviewing registration dossiers for biosimilars, share common challenges and solutions from an industry perspective and contribute to the dialogue on the most appropriate use of statistical tools.

The format of this workshop is designed to facilitate active dialogue between regulators and biosimilar developers, and allow attendees to share perspectives, clarify concerns and, ultimately, increase the quality and success of submissions.

Learn more about the 2018 PDA Biosimilars Workshop.