Building on the success of previous events, SMi has announced the return of its 4^th annual Biosimilars North America Conference, taking place on November 15 and 16, 2017 in Iselin, New Jersey.

The market for biosimilars in North America continues to grow and has become highly lucrative. As such, pharmaceutical companies continue to find ways to differentiate their products in such an emerging market. Thus, Biosimilars North America 2017 will provide an intelligent meeting to explore novel and innovative strategies to advance biosimilar development, and ensure optimal market access and commercialization opportunities whilst complying with evolving regulatory requirements.

This year, the conference will also explore significant developmental topics within the sector including the impact of FDA’s newly implemented biosimilar interchangeability guidelines, the US market access landscape, and biosimilars of orphan drugs.

Key highlights this year will include

• a presentation from Sandoz on the FDA issuing the long-awaited biosimilar interchangeability guidance;
• a session on complex biosimilars and new technologies from MedImmune;
• strategies to combat legal, policy and commercial obstacles to development and launch;
• insights on latest development strategies and market access from Fujifilm Diosynth Biotechnologies;
• case studies on drug product and formulation development considerations; and
• Implications of the landmark ruling of the Amgen v Sandoz case

Key speakers include

• Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals Inc
• Cindy Cao, Executive Director & Head of US Regulatory Affairs fo Biopharmaceuticals, Sandoz
• T. Shantha Raju, Senior Director, MedImmune
• Chrys Kokino, Head Global Biologics Commercial, Mylan
• Steinar Madsen, Medical Director, Norwegian Medicines Agency
• Bruce Leicher, Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc
• Hiten Gutka, Principal Scientist Formulation Development – Biosimilar Development, Oncobiologics Inc
• Patrick Robertson, Director, Program Design, FUJIFIlM Diosynth Biotechnologies

The full roster of speakers and their topics can be found on www.biosimilars-northamerica.com/pharmajournalist

Registration is now live on the event website and there For more information visit: www.biosimilars-northamerica.com/pharmajournalist