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