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![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”)](https://image.slidesharecdn.com/anda-220715050237-878997ea/75/ANDA-pptx-42-2048.jpg)
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ANDA.pptx
- 1. GENERIC PRODUCT DEVELOPMENT ProcessFor Approving Generic Drugs (ANDA) Dr. Prakash Goudanavar DEPARTMENT OF PHARMACEUTICS Sri Adichunchanagiri College of Pharmacy.
- 3. Generic Drug : Ageneric drug is one that is comparable to an innovator drug product in dosage form,strength,route of administration,quality,performance characteristics and intended use. GENERIC DRUGS
- 4. Patient Perceptions The Negatives Iread that generic drugs are not the real thing, they are not pure. I don’t trust generics Generics don’t work for me Why change something that is working I am allergic to generics Brand name drugs taste better Generics don’t seem to work as well I have the best insurance so I can have the best medications possible
- 5. Patient Perceptions The Positives Isthere a generic for drug X? The price has increased so much I can’t afford it... I want to take generics whenever possible to save the healthcare system money. Can we change to another drug that does come as a generic? Does my medication have a generic alternative? Do you know when it will ? Can we use a generic since it will not be as expensive?
- 6. NDA : NEWDRUG APPLICATION GENERIC DRUGS
- 7. ♦ The Developmentof a new pharmaceutical product involves scientific discovery. ♦ Using a number of R&D techniques, an innovator pharmaceutical company will screen chemical compounds for potential use in treating a specific disease. ♦ Once a promising molecule or chemical compound is discovered, it enters the development phase. NDA Involves : GENERIC DRUGS
- 8. There are essentiallyfour phases in the development process : •Pre -Clinical studies : Involves laboratory and animal testing of the compound that is primarily aimed at establishing safety and efficacy. •If successful, the innovator can then file an Investigational New Drug Application (IND) with the FDA, seeking approval to move the compound into a three-phase process of human testing. GENERIC DRUGS
- 9. •At the successfulcompletion of lengthy human clinical trials, the innovator files a New Drug Application (NDA) submission with the FDA seeking to bring new compound to market. •The process required to establish safety and efficacy can take as long as 10-12 years and cost in excess of $500 million. •In order to recapture this investment, the innovator is typically granted a period of market exclusivity. GENERIC DRUGS
- 11. Goal The NDA provideenough information to permit FDA reviewer to reach safety, efficacy and quality for pharmaceutical production
- 12. Phases of clinicaltesting
- 13. ANDA : ABBREVIATEDNEW DRUG APPLICATION GENERIC DRUGS
- 14. ♦ The genericpharmaceutical company, seeking to market an equivalent to an innovators product (once the market exclusivity on the innovator’s product has expired), uses a significantly less costly and faster process, the Abbreviated New Drug Application (ANDA) process. ♦ Under this process, the generic manufacturer relies on the safety and efficacy data supplied by the innovator, and only has to prove to the FDA that its product is equivalent to the branded product. GENERIC DRUGS
- 15. ♦ When processingan ANDA, the FDA waives the requirement for conducting complete clinical studies as safety and efficacy have already been established by the innovator company. ♦ However, it requires the generic manufacturer to conduct bio-availability and /or bioequivalence studies of its version of the branded drug. GENERIC DRUGS
- 16. NDA vs. ANDAReview Process Brand Name Drug Generic Drug NDA Requirements ANDA Requirements 1. Chemistry 1. Chemistry 2. Manufacturing 2. Manufacturing 3. Controls 3. Controls 4. Labeling 4. Labeling 5. Testing 5. Testing 6. Animal Studies 7. Clinical Studies 6. Bioequivalence 8. Bioavailability
- 17. Definition of Bioequivalence(BE) Pharmaceutical equivalents whose rate and extent of absorption are not statistically different when administered to patients or subjects at the same molar dose under similar experimental conditions
- 18. Purpose of Bioequivalence Therapeuticequivalence (TE) Bioequivalent products can be substituted for each other without any adjustment in dose or other additional therapeutic monitoring The most efficient method of assuring TE is to assure that the formulations perform in an equivalent manner
- 19. Bioequivalence Example 6 1218 24 30 36 42 48 0 1 2 3 4 5 6 7 8 Test/Generic Reference/Brand
- 20. Model of OralDosage Form Performance Therapeutic Effect Dosage Form Gut Wall Drug in Solution Blood Site of Activity Pharmacokinetic Measurement Dosage Form Performance Clinical/PD Measurement ln Dose Dose
- 21. Bio-availability studies assessthe rate and extent of absorption and levels of concentration of a drug in the blood stream needed to produce a therapeutic effect. When bio-equivalence is established, it indicates that the rate of absorption and the levels of concentration of a generic product are substantially equivalent to the branded product. GENERIC DRUGS
- 22. •The ANDA processeliminates the lengthy and costly clinical research phase of development. As a result, generic pharmaceutical product development takes approximately 3 years. GENERIC DRUGS
- 23. What are therequirements for a generic drug? Same active ingredient(s) Same route of administration Same dosage form Same strength Same conditions of use Labeling Chemistry/Microbiology Bioequivalence Legal
- 24. Labeling “Same” as brandname labeling May delete portions of labeling protected by patent or exclusivity May differ in excipients, PK data and how supplied
- 25. Chemistry Components and composition Manufacturingand controls Batch formulation and records Description of facilities Specs and tests Packaging Stability
- 26. Selection of Product Currentmarket 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
- 27. Steps involved inGeneric 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)
- 28. Formulation Development Strategy Literature, patentlandscape and innovator design Regulatory strategy and Biostrategy Product development strategy Preformulation and prototype formulation Bench scale and lab scale studies BE batch Exhibit batches
- 29. 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 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
- 30. Execution of exhibitbatches 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)
- 31. Approval Process inUSFDA 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
- 32. APPROVAL PROCES IN EUROPE ObtainingMHRA slot for dossier submission Submission of dossier with all details Review of dossier- time frame Day 70, 100, 105, 145
- 33. APPROVAL PROCESS ININDIA 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
- 34. Hatch Waxman Act Theact 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.
- 35. Product Development Process Product Selection Product Development Testbatch Manufacture •Physical Char •PK Char •General •Pre-formulation •Formulation •Analytical Bio-study ANDA Submission GENERIC DRUGS
- 36. ANDA Approval Process: ANDA Submission FDA Comment and review Period Pre-Approval Inspection Final Approval Product Launch Process & Cleaning Validation GENERIC DRUGS
- 37. Bioequivalence Review Labeling Review Chemistry & Micro Review Requestfor Plant Inspection APPLICANT ANDA Acceptable & Complete Application Review N Chem/Micro OK? Labeling OK? Bioequivalence OK? PreApproval Inspection Results OK? Not Approvable Letter Approval Withheld until Results Satisfactory Bio Deficiency Letter APPROVED ANDA N N N N Y Y Y Y Y Refuse to Receive Letter Generic Drug Review Process
- 38. An ABBREVIATED NEWDRUG APPLICATION contains data which when submitted to FDA, provides for the review and ultimate approval of a generic drug product. Once approved an applicant may manufacture and market the generic drug product to provide a safe,effective,low cost alternative to the public.
- 39. Hatch Waxman Act Theact 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.
- 40. Objectives of theact: 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
- 41. There was noprovision 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
- 42. Provisions of theact 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”)
- 43. An NDA applicantmust 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.
- 44. Four Types ofPatent 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): I. That the drug has not been patented; II. That the patent has already expired; III. The date on which the patent will expire, and that the generic drug will not go on the market until that date passes; and IV. That the patent is not infringed or is invalid. Those certifications are now referred to as the paragraphs I,II,III, and IV certifications.
- 47.