GENERIC DRUG
A generic drug is a pharmaceutical drug product that is pharmaceutically equivalent to a RLD/RS in dosage, strength, route of administration, quality, performance, and intended use, but does not carry the same brand name.
For Development of Generic Drug Product Following Points to be Consider
- Patent expiration, exclusivity and legal issues: the expiration date of the patents for formulation composition and process must be considered.
- Facilities & Technology: Availability of fcilities and technology and cost of acquiring technology for development and manufacturing of generic drug product also to be considered.
- API availability: DMF availability, Impurity profile and stability, Potential Polymorphic forms, Physical specifications e.g. Bulk density and Particle size distribution, Cost of API and Impurities to be considered.
- RLD/RS selection: RLD or RS to be selected as per target regulatory market requirement (e.g., For USA market RLD or RS must be FDA approved or FDA orange book listed).
- Sales and potential market share/volume
- Formulation experts
A TYPICAL PROCESS FLOW OF GENERIC DRUG DEVELOPMENT
- Obtain project proposal from project management department
- Perform literature review and request to the TSD/SCM for RLD/ Reference/ Market sample
- Raise requisition for new API, excipients, packaging materials and analytical requirements to TSD/SCM
- Perform RLD/ Reference/ Market sample characterization
- Identify QTPP and CQA
- Perform Preformulation Study and compile information
- Collect, Review and study the DMF (if available)
- Select Tooling
- Design a prototype formulation
- Perform Drug excipient compatibility study (if required)
- Identify the lead formulation
- Perform stress study (if required)
- Initiate preliminary method development activities
- Manufacture three laboratory batches on the lead formulation
- Select packaging components and submit sample to the packaging department and PMD for evaluation
- Initiate stability study
- Order RMs for PO batch(es) (if required)
- Prepare the recipe for submission/regulatory approval
- Raise CCR and conduct the risk assessment to manufacture PO batch(es)
- Initiate discussion for cleaning validation
- Prepare and obtain approval of process optimization protocol and BMR (if required)
- Manufacture the process optimization batch(es) (if required)
- Submit sample for packaging trial
- Initiate Method Validation activities
- Review stability data and declare shelf life of the product
- Prepare and submit the annexure
- Request PMD/RA to obtain approval for inclusion materials and price from regulatory authority
- Request MMIC to raise the requisition for RMs and PMs for PV batch(es)
- Raise CCR and conduct the risk assessment (if required)
- Prepare and obtain approval of protocol for process and packaging validation batch
- Provide approved BMR and BPR to Production
- Conduct pre-validation meeting and establish roles & responsibility
- Manufacture the process validation batch(es)
- Prepare product development report (PDR) of the drug product
AUTHORIZED GENERIC DRUG
An authorized generic is considered to be therapeutically equivalent to its brand-name drug because it is the same drug. This is true even if the brand-name drug is “single source,” meaning there are no ANDAs approved for that product, or coded as non-equivalent (e.g., BN) by FDA in the Orange Book.
Authorized generics examples
- Prasco Laboratories' colchicine (authorized generic of Colcrys)
- Watson/Actavis' methylphenidate ER (authorized generic of Concerta)
- Greenstone's celecoxib (authorized generic of Celebrex)
- Prasco Laboratories' Hydroxychloroquine (authorized generic of Plaquenil)
FDA New Drug Development Process Include Following Stages
- Discovery and Development
- Preclinical Research
- Clinical Research
- FDA Review
- FDA Post-Marketing Safety Monitoring
Related Articles
- Preformulation Study of Drug
- A Brief Discussion on QbD Tools
- Difference Between RLD and RS
- Pharmaceutical RLD and RS Characterization
- Pharmaceutical Topical Formulation Development
- Sameness Evaluation of a Generic Drug Product Formula
- A Guide to Select the Excipients for Pharmaceutical Formulation Development