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Press Release

Momenta, Pfenex, Sandoz, NMA to explore the regulatory road for biosimilars in North America

SMi Group
Posted on: 12 Sep 17
Momenta, Pfenex, Sandoz, NMA to explore the regulatory road for biosimilars in North America

As the biosimilars market continues to grow, it is important to understand the regulatory hurdles that come with drug development, patent application, approval and launch. SMi's 4th annual Biosimilars North America Conference which takes place on November 15 & 16, will highlight regulatory updates that would aid delegates in biosimilar development and market access.

Momenta Pharmaceuticals Senior Vice President and General Counsel Bruce Lecher will be presenting a relevant topic for the market where he tackles legal, policy, and commercial obstacles to the development and launch of biosimilars.

In this timely presentation, Bruce will cover the use of Public Policy and Guidance to promote evergreening of reference products, as well as the restricted access to reference products and REMS abuse.

Bruce's presentation will complement other sessions focusing on regulatory updates including:

• Biosimilars 12 years on - where are we and what's Next?
Patrick Lucy, CEO, Pfenex

• FDA issues long-awaited biosimilar interchangeability guidance
Cindy Cao, Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals, Sandoz

• From biosimilar approval to biogenerics in clinical practice
Steinar Madsen, Medical Director, Norwegian Medicines Agency

The full roster of speakers and their topics can be found on

Biosimilars North America 2017 will feature 18 presentations and 2 exclusive workshops hosted by industry-leading experts, to provide a forum to explore novel and innovative strategies to advance biosimilar development, and ensure optimal market access and commercialization importunities whilst complying with evolving regulatory requirements.

Registration is now live on the event website and there For more information visit

4th Biosimilars North America
November 15 & 16, 2017
Renaissance Woodbridge Hotel, Iselin, NJ, USA


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About SMi Group:

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at


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SMi Group
SMi Group

Last updated on: 12/09/2017

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