generic product development.pptx

Process involved in Generic product development

1. GENERIC PRODUCT DEVELOPMENT Dr.Prakash G Department of Pharmaceutics

2. Generic Product A generic product is essentially identical to the brand name (reference) drug product in terms of active ingredient(s), dosage form, route of administration, quality, safety,efficacy,performance characteristics and therapeutic indication.

3. Selection of Product Current market sales of innovator product Patent/ exclusivity time frame Complexity in the development and time lines Availability of API, equipment and expertise Competitor intelligence Budget required Return on Investment Therapeutic area of the product Geographies

4. API availability In-house versus out source Patent landscape for API Cost competitiveness Patent protection for the new process/ form/ impurity profile/ residual solvents/stability

5. PROJECT MANAGEMENT Defining the objectives of the project Determining various tasks to be performed Defining the time lines for each task Determination of critical chain Buffer management Finalization of due date Risk identification and mitigation plans Budget and resource allocation

6. Steps involved in Generic Product Development Selection of drug product for development API development ( API R&D )/ sourcing Analytical method development and validation for API and prototype formulation- In vitro methods establishment ( AR&D ) Literature search and patent landscape to identify possible excipients and processes Regulatory strategy for ANDA filing ( RA ) Para IV filing for 180 day exclusivity Pre-formulation and prototype formulations ( FR&D )

7. Analytical method development and validation Analytical method development for API, formulation, dissolution and other tests Method validation for API and impurities (Process and degradation products)

8. Formulation Development Strategy Literature, patent landscape and innovator design Regulatory strategy and Biostrategy Product development strategy Preformulation and prototype formulation Bench scale and lab scale studies BE batch Exhibit batches

9. Steps involved in Generic Product Development Bench scale – 1/100 th of Exhibit batch One month stability and reproducibility Lab Scale- 1/10 th of Exhibit batch One month stability in various packs and reproducibility Pilot BE studies Process validation batch 1/4 th to 100% Resolving process issues ( PD ) Initiation of Exhibit batch Pilot BE clearance, Stability data clearance, analytical method transfer, procurement of excipients and specific equipment, In process quality control, specifications, BMR

10. Steps involved in Generic Product Development Execution of exhibit batches Stability loading in different packs (Packaging) Pivotal BE studies ANDA preparation ( RA ) Submission to FDA ( RA ) Legal/ Regulatory Process ( Legal and RA ) Approval Commercial validation ( QA & QC ) Commercial Batches and Launch ( Marketing )

11. Approval Process in USFDA Office of Generic Drugs (OGD) is responsible for processing and approving ANDA ANDA is reviewed for completeness before initiating approval process ANDA is reviewed under four sections Plant inspection report Chemistry/microbiological Labelling Bioequivalence Tentative approval is given if time to launch the product is ahead of approval If patent litigation is in progress, the approval will be held for 30 months or judgment in favor of ANDA is given, which ever is earlier Approval to market is issued If no hurdles are present

12. APPROVAL PROCES IN EUROPE Obtaining MHRA slot for dossier submission Submission of dossier with all details Review of dossier- time frame Day 70, 100, 105, 145

13. APPROVAL PROCESS IN INDIA Submission of application Details required for approval API related details Formulation composition, process, manufacturing controls, stability data BE report or BE and CT reports if first time in India DCGI and DCA routes

14. Hatch Waxman Act The act which surrounds the generic drug approval process of the USFDA is the “Hatch Waxman Act of 1984” which we also identify by the “Drug price control and Patent Term Restoration Act of 1984” which led to a plethora of generic drugs entering into the market.

15. Objectives of the act: Reducing the cost associated with the approval of a generic drug Allowing Early-Experimental-Use Compensating the branded drugs manufacturers for the time lost from the patent term because of the regulatory approval formality Motivating the generic drug manufacturers

16. There was no provision for patent term extension prior to enactment of the Hatch Waxman Act, to make up for the time lost out of the total patent term during the marketing approval process Generic companies required to submit their own comprehensive NDA Costly Time consuming If drug was covered by patent Testing could not begin until patent expired To overcome the above problems an act was needed to promote generic companies

17. Provisions of the act Creation of section 505(j) Section 505(j) established the ANDA approval process The timing of an ANDA approval depends in part on patent protections for the innovator drug NDA must include any patent that claims the "drug" or a "method of using [the] drug" for which a claim of patent infringement could reasonably be asserted On approval of NDA, FDA publishes patent information for drug in Orange Book (“Approved Drug Products with Therapeutic Equivalence Evaluations”)

18. PROVISIONS OF THE ACT An NDA applicant must submit the following information for each patent: Patent no and date on which the patent will expire. Type of patent i.e. drug, drug product or method of use. Name of patent owner. The name of an agent of the patent owner or applicant.

19. Brand drugs listed for generics to compare with their proposed products. Four Types of Patent Certifications When an applicant submits an ANDA to the FDA, the applicant must certify one of four things under section 505(j)(2)(A)(vii): That the drug has not been patented; That the patent has already expired; The date on which the patent will expire, and that the generic drug will not go on the market until that date passes; and That the patent is not infringed or is invalid. Those certifications are now referred to as the paragraphs I, II, III, and IV certifications.

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