GENERIC PRODUCT DEVELOPMENT by Dr. V. VENKATESWARLU

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GENERIC PRODUCT DEVELOPMENT : 

GENERIC PRODUCT DEVELOPMENT Dr. V. VENKATESWARLU Senior Director Head, FR&D, Biostudies and Packaging IPDO Innovation Plaza Dr.Reddy’s Laboratories

Generic Product : 

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. Hatch-Waxman Act- Drug Price Control and Patent Restoration Act 1984

Business potential of Generic products : 

Business potential of Generic products In 2002, about 47% of prescription drug products are generic versions while 53% innovator products Total cost of prescription drugs is 192 billion dollars. The cost of generic products was only 10% (19.2 b $) indicating cost ratio of 1:18. The generic products growth rate is 19% in 1984, 36% in 1994 and 50% in 2004 Every year about 4 billion dollars business potential exists for next four years due to patents expiry

Selection of Product : 

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

API availability : 

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

Regulatory Strategy : 

Regulatory Strategy NCE-1 Para I, II, III &IV FTF, launch on approval, LTF 180 day exclusivity Exclusivity for the innovator: Orphan drug- 7 years NCE – 5 years 505B2- 3 years Pediatric – 6 months Out licensing/ partnership

Biostrategy : 

Biostrategy Pilot BE studies Pivotal BE studies: Fasting, Fed and steady state studies; statistical design, volunteers, bioanalytes

PROJECT MANAGEMENT : 

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

Steps involved in Generic Product Development : 

Steps involved in Generic Product Development Selection of drug product for development (BD) API development (API R&D)/ sourcing (SCM) 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 (IPM) Regulatory strategy for ANDA filing (RA) Para IV filing for 180 day exclusivity Pre-formulation and prototype formulations (FR&D)

Analytical method development and validation : 

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)

Formulation Development Strategy : 

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 PE batch Exhibit batches

Steps involved in Generic Product Development : 

Steps involved in Generic Product Development Bench scale – 1/100th of Exhibit batch One month stability and reproducibility Lab Scale- 1/10th of Exhibit batch One month stability in various packs and reproducibility Pilot BE studies (COE BIO, CPPK & Bioanalytical) Process validation batch 1/4th 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 PDR (FR&D)

Steps involved in Generic Product Development : 

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

Approval Process in USFDA : 

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

APPROVAL PROCES IN EUROPE : 

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 Stop clock

APPROVAL PROCESS IN INDIA : 

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

THANKS YOU : 

THANKS YOU There is no substitution for sincerity and hard work

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