Challenges and Opportunities in Biosimilar Development and Commercialization


Jump to the Agenda for Each Day: Day One | Day Two | Day Three


When biosimilars first became available, their all-consuming struggle was establishing legitimacy as replacements for originator (“reference”) biologics. But now that biosimilars have achieved broad acceptance and market penetration, the rules of competition are in flux. 

Now, with increasing competition and regulatory evolution occurring across the globe, the biosimilar market is ripe for innovation – and developing the optimal clinical development and commercial strategy is key to maximizing the value of your biosimilar asset. 

This three-day symposium will provide an overview of the current challenges and opportunities in biosimilar development and commercialization, and discuss expectations and requirements from key stakeholders such as manufacturers, physicians, patients and payers. 


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In this symposium, attendees will: 

  • Understand the US and European landscape and how APAC developers can bring their biosimilar products to Western markets 
  • Learn how physician and patient expectations impact the clinical evidence needs critical to trial planning 
  • Explore the evolution of market demands that influence how we will commercialize biosimilars now and in the future 


Day One | From Asia to the World – Global Biosimilar Development


October 26, 2021 (90 Mins)

4PM CST (Beijing) | 5PM JST (Tokyo) | 5PM KST (Seoul) | 1:30PM IST (New Delhi) | 4:00AM EDT (New York)



Nick Kenny, PhD, Chief Scientific Officer, Syneos Health 


Growing Impact of Asia in Biosimilar Development 

Manfred Weiler, PhD, Senior Vice President, Medical & Scientific Strategy, Head of Biosimilars Consortium, Syneos Health 


Designing a Global Biosimilar Program - Comparison of Regulatory Guidelines in US, EU, China, Japan

Zohra Lomri , Senior Director, Regulatory Consulting, Syneos Health 


Manufacturing and CMC Comparability Programs 

Steve LoCastro, Senior Director, Regulatory Consulting, Syneos Health 


Panel Discussion - Opportunities and Challenges for Asian Biosimilar Developers 

Parisa Asvadi, Chief Development Officer, Neuclone 

Dr. Sandeep Athalye, Chief Medical Officer, Biocon

Day Two | Clinical Evidence – Expectations from Physicians and Patients


October 27, 2021 (90 mins)

10:00AM EDT


Selection of Indications and Endpoints – Balancing Requirements on Patient Population, Treatment Effect and Marketing Needs

Angel Uriol, Vice President, Clinical Development, Syneos Health 


Challenges from Extrapolation, Switching and Interchangeability 

Anna La Noce, Executive Medical Director, Syneos Health 


New MHRA Guideline: Dropping Clinical Efficacy Studies - The Future of Biosimilar Clinical Development? 

Catherine Edwards, Senior Director, Regulatory Consulting, Syneos Health 


Panel Discussion - Expectations From Key Stakeholders – What Clinical Data Is Required?

Wael Harb, Vice President, Medical Affairs, Syneos Health 

Molly Schreiber, Community Manager, Savvy Cooperative

Dr. Jose-Luis López Lorenzo, Department of Hematology, Jiménez Diaz Foundation

Day Three | Biosimilar Commercialization 


October 28, 2021 (90 Mins)

10:00AM EDT 


Uptake of Biosimilars in US and EU – A Comparison

Rafal Kokolus, Senior Engagement Manager, Portfolio and Commercial Strategy, Consulting, Syneos Health 


Current Challenges and Hurdles in Marketing Biosimilars – Feedback from the Industry

Michael Sarshad, Director, Commercial Advisory Group, Consulting, Syneos Health 


Branding of Biosimilars – It’s Time to Change

Justin Holloway, Head of Client Strategy, Communications Europe, Syneos Health 


Panel Discussion – Expectations from Payers and Marketers 

Andreas Reinbolz, Managing Director Communications, Syneos Health 

Lisa Günther, Head of Global Business Insights, Sandoz

Shawn Davis, US Pharmacy Director, United Health


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Tue, Oct 26, 04:00 am to Thu, Oct 28, 11:30 am
Additional Details