Biosimilars USA Conference

Iselin, NJ, United States

Building on the success of previous events, we proudly announces the return of its 5th Annual Biosimilars USA Conference, taking place in New Jersey on the 14th and 15th November 2018.

This fifth event in the series will gather a global audience of biosimilar experts and industry-thought leaders to discuss biosimilar manufacturing and commercialization considerations specific to the U.S..

Fresh form the press: On March 7th, 2018, the U.S.- FDA's Commissioner, Scott Gottlieb, MD, announced that Biosimilar medicines are now a top priority for the FDA. Join us this November to learn how to take advantage of the FDA's focus on biosimilars, accelerate your biosimilar pipeline and achieve FDA approval.

Hear from a selection of carefully handpicked keynote addresses and case studies presented to you by top manufacturing and leading distributors of market approved biosimilars, as they offer a unique insight into the areas of manufacturing, commercialization, device design, uptake, switching, interchangeability, and regulations.

''If we're serious about seeing the market for biosimilars take shape, it's going to require a payment system that gives products that are currently in the pipeline a chance to enter the market once they're approved.... The FDA will do its part by laying out an efficient path for showing how biosimilar products can demonstrate interchangeability with their branded counterparts. But we can solve only one part of this equation.''

Benefits of Attending

  • Assess challenges to gaining the FDA's Interchangeability status and debate, is it worth it?
  • Consider different device design options
  • Explore routes to take if your biosimilar has a better formulation and/or administration than the originator
  • Discuss the FDA's CMC finger print comparability that requires a minimum of 10 batches for statistical considerations
  • Examine whether more batches lead to better clinical trial outcomes
  • Learn how to meet high GMP compliance when manufacturing outside of the US
  • Analyze whether the biosimilar industry can provide co-payments and other healthcare benefits to patients to successfully complete with originators
  • Discover how to get onto patient formularies, and the important role pharmacy benefit manages have in achieving this

Who should attend

Medical Directors, Scientific Directors, VP's, Directors, Managers, Team Leaders, Partners, Consultants and Attorneys of:

Biosimilars, Biobetters, Biopharmaceuticals, Biostatistics, Business Alliances, Business Development, Clinical Operations, Commercial, Decision Analytics, Global Intelligence, Global Operations, Managed Markets and Trade Relations, Market assess, Marketing, Patient & Physician Services, R&D Policy, Regulatory Affairs, Scientific Affairs, and anyone else who works within the biosimilars industry!

Plus Two Interactive Half-Day Pre-Conference Workshops | Tuesday 13th November 2018

Workshop A: Decoding How Stakeholders May Drive Biosimilar Adoption
Workshop Leaders: Tucker Herbert, Manager, ZS Associates
Christina Corridon, Associate Principal, ZS Associates
08.30 - 12.30

Workshop B: Dealing with Life Sciences Patents at the PTAB
Workshop Leaders: Ha Kung Wong, Partner, New York, Fitzpatrick, Cella, Harpper & Scinto
John Kirkland, Director, Intellectual Property, Alkermes, Inc.
13.30 - 17.30


  • Anita Burrell, Founder and CEO, Anita Burrell Consulting
  • Arun Nataraj, Senior Director, Amneal Pharmaceuticals
  • Catherine Soo, Senior Clinical Evaluator, Health Canada
  • Christina Yunis, Global Biosimilars Market Development Lead, Pfizer
  • Christopher Loh, Partner, FITZPATRICK, CELLA, HARPER & SCINTO
  • Don Stewart, CEO, PlantForm Corp
  • Edric Engert, SVP Biosimilars, Teva Pharmaceuticals
  • Ha Kung Wong, Partner, New York, FITZPATRICK, CELLA, HARPER & SCINTO
  • Hillel Cohen, Executive Director, Scientific Affairs, Sandoz Inc
  • Hiten Gutka, Principal Scientist Formulation Development Biosimilar Development, Oncobiologics
  • Houng Kim, Senior Director, Celltrion Inc.
  • Magdalena Leszczyniecka, Founder and CEO, STCBiologics Inc
  • Nigel Rulewski, Vice President, Head Biosimilar Center of Excellence, IQVIA
  • Peter Waibel, Head of US Patent Litigation, Novartis
  • Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.
  • Sarfaraz Niazi, Founder, Karyo Biologics, LLC
  • Steinar Madsen, Medical Director, Norwegian Medicines Agency


Renaissance Woodbridge Hotel
515 US Highway 1 South
Iselin, New Jersey, USA
Event details
Organizer : SMi Life Sciences
Venue : Renaissance Woodbridge Hotel, Iselin, NJ, United States
Event type : Conference
Reference : ASDE-18920