FDA and healthcare partner and co-chair of firm-wide Life Sciences and Healthcare initiative, Stephen Paul Mahinka will present on biosimilars topic at the ACI's workshop "Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics" during FDA Boot Camp.
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Topics to be discussed include:
- Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
- ANDA filing: what does FDA require?
- Showing bioequivalence in an ANDA
- ANDA Paragraph IV Certifi cation, and response to Notice Letters
- The role of the Orange Book in the drug approval process: what is it and why is it Orange?
- Regulatory exclusivity (FDA)
- NCE (new chemical entity)
- Indication (new indication or use)
- NDF (new dosage formulation)
- ODE (orphan drug exclusivity)
- PED (pediatric exclusivity)
- Overview of Hatch-Waxman and reforms under MMA
- The role of Orange Book under Hatch-Waxman vis-à-vis the MMA
- Identifying products approved/regulated as biologics
- Overview of biosimilar (FOB) legislation and regulations
- The rationale for safety and efficacy concerns surrounding second generation biologics
Friday, September 21, 2012
2-4 pm ET
Omni Parker House, Boston
60 School Street
Boston MA, 02108