Learning Tracks

Streamlining Biosimilars Development

1:30 p.m. - 3:00 p.m.

Biosimilars have traveled a long road and despite more than 1 million patient-years showing no efficacy and safety concerns today, there is still a need to make and keep biosimilar development cost-effective and sustainable. To do so, regulatory requirements must see a natural evolution toward optimal harmonization and a shift toward removing any inefficiencies in clinical designs. This session will consider the challenges for biosimilar development and regulatory assessment in the face of improving analytical methods and evolving cost-benefit calculations for investing in clinical trials. Panelists also will discuss how to move regulators, patients, and healthcare providers in the direction of accepting analytical data to support biosimilarity and interchangeability, including regulatory science and public education efforts.


Fouad Atouf, PhD
Senior Vice President, Global Biologics, U.S. Pharmacopeia

Ravi Harapanhalli, PhD
Senior Vice President, Research and Development Operations, Amneal Pharmaceuticals

Kristen Nickens, PhD
Product Quality Team Lead, Division of Biotechnology Review and Research I, OBP, OPQ, CDER, FDA

Cory Wohlbach
Vice President, Global Biosimilars Regulatory Affairs, Teva Pharmaceuticals

Elena Wolff-Holz, M.D., PhD
Vice President, Global Head Clinical Development, Biocon Biologics Ltd

Sarah Yim, M.D.
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA


Martin Schiestl, PhD
Global Head Regulatory Affairs Policy, Sandoz