Innovator drug

&
generic drug
What Is Innovator Drugs?

An innovator drug is the first drugs created containing its specific active
ingredient to receive approval for use.

It is usually the product for which efficacy, safety and quality have been fully
established.

When a new drug is first made, drug patent usually will be acquired by the
founding company.

Most drug patents are protected up to 20 years. During the patent period,
other companies cannot make or sell the same drug until the patent expires.
 New Molecular
Entity

Already
Marketed Drug New Salt of
Product - No Previously
Previously Approved Drug
Approved NDA

Innovator drug Classifications

New Indication New

(claim) for Formulation of
Already Previously
Marketed Drug Approved Drug

New
Combination of
Two or More
Drugs
What Is Generic Drugs?
A generic drug is made of the same active ingredient as its innovator
drug.

An active ingredient is the chemical contained inside a drug that

makes it work.

In other words, the pharmacological effect of a generic drug is the

same as those of its innovator counterpart.

Other companies can manufacture the generic drugs when the patent
expires
Are innovator drugs and generic drugs
similar?
• Yes, There are similarities between generic and innovator drug,
such as:

Active Therapeutic
How to take
ingredient effect

Strength
Side effects
(dose)
Myths of Generic Drugs

• Generic drugs are not as safe as innovators.

• Generics drugs are not as effective as innovator

• Generic drugs take a longer time to act in the body.

SELECTION OF GENERIC DRUGS FOR MANUFACTURE

Estimated Sales Volume For The Branded Product.

Potential Market

Any Other Patent Claims And Exclusivities That The Innovator Firm Has Filed

Lead Time That Is Needed To Make The Product And Submission An Abbreviated New
Drug Application (ANDA)

Formulation Considerations
 What standards must generic medicines meet to
receive approval?
Drug companies must submit an abbreviated new drug application (ANDA) for
approval to market a generic drug that is the same as (or bioequivalent to) the
brand product. An ANDA must show the generic medicine is equivalent to the
brand in the following ways:
• The active ingredient is the same as that of the brand-name drug/innovator drug.
• The generic medicine is the same strength.
• The medicine is the same type of product (such as a tablet or an injectable).
• The medicine has the same route of administration (such as oral or topical).
• It has the same use indications.
• The inactive ingredients of the medicine are acceptable.
• It lasts for at least the same amount of time.
• It is manufactured under the same strict standards as the brand-name medicine.
• The container in which the medicine will be shipped and sold is appropriate.
• The label is the same as the brand-name medicine's label.
• Relevant patents or exclusivities are addressed.
 GENERIC DRUG
DEVELOPMENT PROCESS
• The Office of Generic Drugs (OGD) follows a rigorous review
process to make sure that, compared to the brand-name (or
innovator) medications, the proposed generic medications:
• Contain the same active/key ingredient;
• Have the same strength;
• Use the same dosage form (for instance, a tablet, capsule, or
liquid);
• Use the same route of administration (for instance, oral,
topical, or injectable)
• As a copy of the brand-name drug FDA originally reviewed, a generic drug application submitted to
FDA for approval must show that:

The generic drug is

The manufacturer is capable of The manufacturer is capable of
"pharmaceutically equivalent" to the
making the drug correctly. making the drug consistently.
brand.

The right amount of the active

The “active ingredient” is the same The "inactive" ingredients of the
ingredient gets to the place in the
as that of the brand. drug are safe.
body where it has effect.

The drug does not break down over The container in which the drug will The label is the same as the brand-
time. be shipped and sold is appropriate. name drug’s label.

Relevant patents or legal

exclusivities are expired
Signed FDA form 356h.

Information on the basis for which the ANDA is being submitted.

Condition for use,

Route of administration, dosage form & strength

Labeling

Chemistry, Manufacturing & Controls

Human Pharmacokinetics & Bioavailability.

Samples

Case report forms & tabulations.

 THE ANDA FILLING PROCESS Office of Generic Drugs
Immediate Office
• APPLICATION is submitted to OGD(OFFICE OF GENERIC •Review applications for the approval of
DRUG) generic drugs Office of
• 6 digit ANDA application is assign and stamps a •Serve as the central point of contact
Bioequivalence
received date on the cover letter of ANDA between applicants and the FDA Generic
• CONSUMER SAFTEY TECHNICIAN who reviews the Drug Program.
preliminary section of ANDA checklist Office of Generic Drug
•Provide guidance and regulatory oversight

OGD
• RSB (REGULATORY SUPPORT BRANCH) is responsible to Policy
to industry on a wide variety of clinical,
carried out this process and has to be completed within scientific, and regulatory matters relating to
the first 60 days
generic drugs. Office of Regulatory
• To determine whether the application is accepted for •Ensure that FDA fulfills Generic Drug User
Operations
filling the RPM(RSB Project manager) compares the
content of each section against the list of regulatory Fee Amendments review commitments.
requirement. •Conduct and Office
administer researchand
of Research in
• Once RSB complete the review process Upon filling of support of the GDUFA Regulatory Science
Standards
ANDA , RPM forwards an Establishment Evaluation Plan.
Report (EER) to the office of regulatory compliances and •Interact with external stakeholders such as
operation (ORO) Office of Safety
physicians, pharmacists, andand
patients,
• and after verification acknowledgement letter is send patient advocacyClinical
groupsEvaluation
to investigate
to applicant as “ACCEPTED” or “REFUSE TO RECEIVE” reports of adverse events or therapeutic
letter is issued with list of deficiencies.
inequivalence of generic drugs.
• Application is then assigned to
“TECHNICAL REVIWERES”
• FDA accepting the ANDA on in electronic
form.
• All applicant has to followed the e-CTD
guidelines.
• The patent certification and exclusivity
statement must address all existing patent
and exclusivities for RLD(Reference List Of
Drug) published in the “ORANGE BOOK”
• If RLD has expired patent then applicant may
certify with no relevant patent.
• Now the application enters in review queue.
• The application is
assigned to • Each team consist of team leader, a project
✓Division of Bioequivalence study manager and several reviewers,
• The chemistry project manager is serves as
✓Division of CMC “APPLICANT PROJECT MANAGER”, They plan ,
organize and co-ordinate all the review activities
✓Division Of Clinical Review • APM serves as C0-Leaders for chemistry review
team.
✓Division Of Clinical Safety And • APM plays a key role in co-ordinating the various
Surveillance disciplines to review the applications within 180
days from the date of submission.
✓Division Of Pharmacology • APM enter the key information about their
applications into a project management database.
/Toxicology Review • They are designated as the primary contacts for all
✓Division Of Labelling Review issues relating of application. It attempts and
address all applicant enquiry within two working
days of receiving request.
 Division of Bioequivalence Study
• The BE section is assigned to DBE for the review
purpose • The DBE is organized in to three
• BPM(Bioequivalence Project Manager) branches of which each branch is
• DBE Assesses pharmacokinetic, pharmacodynamic consist of six reviewers supervised
and in vitro data to ensure therapeutic
equivalence. by team leader (2nd review) and
• This process established BE between generic and DBE division director (3rd review )
RLD. They establishes the ratio of T/R.
• A BPM is assigned to each branch
• Evaluates formulations for excipient safety,
proportionality and qualitative (Q1) and (processing and managing ) and
quantitative (Q2) sameness. statistician for statistical issues.
• Addresses scientific and regulatory challenges, • The BPM request and track
product safety, drug product quality and
methodologies/approaches for demonstrating inspections of the Clinical and
bioequivalence by collaborating with various Analytical sited through the (DSI) ;
offices within OGD, and throughout CDER and FDA.
• If any deficiencies are determined “BE deficiency
Division of Scientific Investigation.
letter” is issued to applicant. • Bioequivalence Telephonic
• If all complied , DBE forward acceptable letter to amendment
APM
• The CMC of the application is assigned to Division of CMC
the chemistry division and team based on
therapeutic category of the drug product. • The CMC is organized in to three
• First in-first reviewed policy. branches of which each branch is
consist of six reviewers supervised
• Chemistry division reviews CMC section
ANDA, DMF, ANNUAL REPORTS & by team leader (2nd review) and
Controlled correspondence Deputy Director (3rd review )
• After the issues resolved , APM
• The goal of CMC process is to assure that
the generic drug will be mfg in a responsibility is to communicate
reproducible manner under controlled the status of the application to
substances. applicant.
• Area such as raw material specifications • If CMC related deficiencies are
and control, manufacturing data, informed to IO and its contacted to
sterilization process, container and applicant.
closures systems, stability data. • CMC Telephonic amendment
 Division Of Labelling Review
• The labelling section is assigned to DLPS.
• The basic for the labelling review is to • To ensure that generic and RLD
ensures that the generic drug labelling is label is same:
“same as ” the RLD labelling. • the reviewer must first identify
• The applicant may submit FOUR copies of the RLD
draft labelling or 12 copies of final printed • Next is to find out the Most
label. recently approved labelling for
• Submission of e-Label RLD,
• Discontinued labelling
• The labelling reviewer identifies the • Team leader completes the
resolves the concerns about medication secondary review.
errors.
• After the issues resolved , APM
• A tentative approval may be issued for responsibility is to communicate
application with outstanding patent and with the applicant regarding
exclusivity issues. deficiencies in label .