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.