20 years of Biosimilars: Are We on the Right Track?

September 27th 2023 from 3:30-4:30 pm CET, 2:30-3:30 BST

Join us for the next Science Huddle Live

For nearly 20 years, biosimilars have been at the center of a great debate. Originators have challenged whether these drugs can be replicated with the original’s exact structure, while regulators have been more open to the types of data and clinical studies necessary to demonstrate biosimilarity. Meanwhile other stakeholders, including providers, payers, and patients, have welcomed the promise of cost savings. With 2022 seen as a pivotal point as more of these biologic similars came to market, the debate has progressed from viability and feasibility to sustainability. Cost, regulatory guidelines, incentives, efficacy, and patent expirations are now at the center of today’s industry discussion. As more biosimilars prove they can deliver new competition and lower costs to patient-critical treatments, the dialogue is also shifting. Join this lively discussion on the challenges and opportunities that biosimilars present and learn more about the speakers’ perspectives as they explore the newest thinking, latest strategies, and next steps for improving biosimilar access and uptake; including:
  • The biggest challenges and the “next big thing” for biosimilar as we move into 2024
  • How regulators are grappling with the “gray areas” of biosimilars to ensure their safety and effectiveness
  • Whether the dynamics between originator companies and regulators have evolved over time and in what ways
  • The types of incentives for biosimilars of orphan drug biologicals that would make them worth developing


Christian K Schneider, M.D.


Vice President, Head of Biopharma Excellence and Chief Medical Officer (Biopharma), at PharmaLex.

Before joining PharmaLex, Dr. Schneider was interim Chief Scientific Officer as the UK’s medical products regulator, MHRA. He was Director of the National Institute for Biological Standards and Control (NIBSC), an agency within the MHRA.

Dr. Schneider has broad global regulatory authority experience, having served as Medical Head of Division Medicines Licensing & Availability at the Danish Medicines Agency and as Head of Division EU Cooperation/Microbiology at the Paul-Ehrlich-Institut, Germany’s Federal Agency for Vaccines and Biomedicines.

Previous to that, he held various senior delegate roles at the European Medicines Agency (EMA), including serving as Chair of the EMA’s Committee for Advanced Therapies (CAT) and member of the EMA’s Committee for Medicinal Products for Human Use (CHMP). In addition, he was chair of the EMA’s Biosimilar Medicinal Products Working Party (BMWP) for nine years and was one of the key architects of the agency’s advanced therapies and biosimilars framework. As a regulatory scientist, he has published more than 50 articles in international peer-reviewed journals.

Dr. Leah Christl

Event Panelists

Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy at Amgen.

Dr. Christl serves as head of the global biosimilars regulatory affairs team within GRAAS-Global CMC, Device & Biosimilar Regulatory Affairs with responsibility for development and execution of global regulatory strategy for Amgen’s biosimilars portfolio. 

Also leads the global biosimilars regulatory and R&D policy with responsibility to develop and advance Amgen’s regulatory and R&D policy positions. Prior to joining Amgen, Dr. Christl served as the Associate Director for Therapeutic Biologics in the Office of New Drugs in the U.S. FDA and was also the director of the Therapeutic Biologics and Biosimilars Staff. 

She is a scientific, regulatory, and policy expert on therapeutic biological products and a strategist and lead for international activities related to biosimilars and other policy areas. Has received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina.

Martin Schiestl

Event Panelists

Martin received his doctoral degree in chemistry with a specialization in bioanalysis from the University of Innsbruck in Austria in 1996. 

In the same year, he started his work on Biosimilar medicines at Sandoz where he built up the analytical and pharmaceutical development departments in charge of the biosimilar portfolio and other biological medicines of Sandoz.

He moved into the regulatory and policy field in 2009, further fostering regulatory sciences for biosimilar medicines and supporting development and licensing of Sandoz’ biosimilar portfolio.

In his current role, he is responsible for the Global Regulatory Affairs Policy at Sandoz Biopharmaceuticals.

Elena Wolff-Holz

Event Panelists

Global Head Clinical Development, Biocon Biologics. Until April 2023, Dr. Wolff-Holz had been employed as a regulator at the Paul-Ehrlich-Institut for 14 years and held the position of chair of the Biosimilar Medicinal Products Working Party (BMWP) within the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for six years until December 2022.

She also served as alternate member of the Scientific Advice Working Party (SAWP) of the CHMP since 2017 and was member of the Oncology Working Party for 4 years prior to that.

With more than 25 years of experience, Dr. Wolff-Holz gained extensive knowledge in the development of biologic therapeutics, with a focus on cancer and immunology. Prior to her work as regulator, she held several leadership positions in clinical development and medical marketing functions at major biotech companies, including Centocor Inc (now Janssen, J&J) and Amgen, in both the US and Germany.

About the Science Huddle events

The Science Huddle, sparked by Biopharma Excellence, is a series of quarterly panel discussions, featuring stakeholders from across the life sciences ecosystem, focusing on the complex challenges that can arise in the race to bring critical, cutting-edge treatments to patients.

At each event, our esteemed panelists bring to the table their latest experiences, concerns, questions and ideas in a highly interactive live session with a view to identifying a positive and actionable way forward.

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