The first biosimilar product launched in the US in 2015. Currently there are only 4 biosimilar products approved but the North Americas market continues to grow and has become highly lucrative. As such, pharmaceutical companies continue to find ways to differentiate their products in such a saturated 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 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
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
- Hiten Gutka, Principal Scientist Formulation Development - Biosimilar Development, Oncobiologics Inc
- Patrick Robertson, Director, Program Design, FUJIFIlM Diosynth Biotechnologies
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 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
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
- Hiten Gutka, Principal Scientist Formulation Development - Biosimilar Development, Oncobiologics Inc
- Patrick Robertson, Director, Program Design, FUJIFIlM Diosynth Biotechnologies
