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. 

 

Register Now

 

 

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)

 

Welcome

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

 

Register Now

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