Generic Drug Approval Process

Transcription

1 1 Generic Drug Approval Process Sharon Ricciardo Katherine P. Weld. M.S., Ph.D. AAVPT Veterinary Drug Regulatory Life Cycle Course March 2, 2011 Overview Background Approval Process Bioequivalence Special Considerations References 2 History Generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988 provides for: Abbreviated New Animal Drug Application (ANADA) List of US FDA Approved Animal Drug Products Marketing Exclusivity 3 years and 5 years Patent term restoration 3

2 4 Why do we need Generics? Cost savings: Veterinarian Farmer Pet Owner Alternative to compounded drugs Generic animal drugs are evaluated for: Bioequivalence Manufacturing Standards Drug Residues We Do It All Companion Animals Production Animals

3 And some you wouldn t expect Do We or Don t We? Do Type A medicated articles Finished dosage forms Combination products Don t Recombinant products Genetically engineered Conditionally approved products (MUMS) 8 Approval Copying an already approved new animal drug Active Ingredient Strength, Dosage Form, Route of Administration Labeling Approval of all indications, species, warnings, cautions, and directions for use of the reference listed new animal drug (RLNAD) Exceptions Suitability petition Hybrid generic approvals 9

4 10 Process Mirrors the NADA processes Traditional applications Phased review Different technical sections Followed by an administrative ANADA Technical Sections for Approval Bioequivalence Not safety and effectiveness Chemistry, manufacturing, and controls Environmental impact Human food safety (if applicable) Residue depletion Patent Certification and Marketing Exclusivity Labeling Freedom of information summary 11 Bioequivalence Two products are considered to be bioequivalent when they are equally bioavailable; that is equal in the rate and extent to which the active ingredient becomes available at the site of drug action. 12

5 13 Bioequivalence Waivers Studies In vivo Pharmacokinetic (blood-level) Clinical endpoint Pharmacologic (physiologic) endpoint In vitro Dissolution Solubility Palatability Blood-Level Bioequivalence Studies Criteria Sufficient Absorption Systemic Absorption is Relevant to Drug Action Study Design 2 period, 2 treatment Cross-over, Comparison of Test (generic) and Reference (pioneer) Pivotal Parameters (rate and extent of absorption) Cmax, AUC (log transformed) 14 Clinical End-Point Bioequivalence Studies Criteria Insufficient Absorption Site of Action Study Design Parallel Test (generic), Reference (pioneer), Placebo (negative) Control Challenges Number of Animals, Difficult to Design 15

6 16 Special Considerations Innovation Suitability Petitions Hybrid Generic Animal Drugs Safety/Effectiveness Studies Special Considerations Hybrid Generic Animal Drugs Criteria Process One Step original application includes enhancement Two Steps supplement to an approved generic new animal drug 17 Helpful Hints No generic animal drug regulations Contact us before submitting an application or sending in a submission If you are a current generic animal drug sponsor, we encourage you to set up a meeting to talk about your challenges and submission quality. 18

7 19 References CVM Guidance for Industry 35: Bioequivalence Guidance CVM Guidance for Industry 171: In Vivo Bioequivalence Waivers in Soluble Powders and Type A Medicated Articles CVM Guidance for Industry 145: Bioanalytical Method Evaluation Good Laboratory Practice for Non-Clinical Laboratory Studies Regulations (21 CFR Part 58) Current Good Manufacturing Practice Regulations (21 CFR Parts 210, 211) Questions? 20 Contact Information Sharon Ricciardo, Team Leader, CSO Review Team sharon.ricciardo@fda.hhs.gov Katherine P. Weld, Team Leader, Review Team katherine.weld@fda.hhs.gov 21