Drugs

• Overview of Hatch-Waxman and reforms
• 30-month stay; patent extensions; ANDA filer exclusivity (180 day)
• Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
• Reviewing fundamentals of applications
• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
• Examining ANDA Standards for approval and the concepts of sameness and bioequivalence
• Special considerations: local acting drugs, labeling carve outs and other nuances
• Understanding the role of the Orange Book in the drug approval process
• Market exclusivities and protection
• Identifying the different types of exclusivities
• Regulatory exclusivity (FDA)/ (data) exclusivity
• NCE (new chemical entity)
• 5 years data exclusivity
• Indication (new indication or use)
• 3 years marketing exclusivity
• NDF (new dosage formulation)
• ODE (orphan drug exclusivity)
• PED (pediatric exclusivity)

Biologics

• Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
• Understanding the rationale for safety and efficacy concerns surrounding second generation biologics
• Exploring the concepts of “biosimilarity” or “interchangeability”
• FDA rulemaking and guidance relative to biosimilars
• Other points for consideration: substitution, naming, patents, and additional nuances
• Examining biosimilar exclusivities
• “Shall we dance” — weighing the pros and cons of participating in the patent dance
• Deciding when to provide notice of commercial marketing