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
• Momenta Pharmaceuticals will provide strategies to combat legal, policy and commercial obstacles to development and launch
• Insights on latest development strategies and market access from Fujifilm Diosynth Biotechnologies
• A talk on drug product and formulation development considerations with Oncobiologics