2. CONTENTS
Introduction.
Legislative history.
When generic drug marketed.
Approval requirement for generic drug
Bioequivalence
Clinical research for generic drugs
ANDA
Life cycle of generic drug.
Indian generic drug market.
FDA regulation for generic drug
Conclusion
References
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3. INTRODUCTION
A generic drug is defined as "a drug product that is comparable
to brand/innovator drug in dosage form, strength, route of
administration, quality and performance characteristics, and
intended use.“ It should contain the same active ingredients
as the original formulation.
According to the FDA, generic drugs are identical or within an
acceptable bioequivalent range to the brand-name
counterpart with respect to pharmacokinetic and
pharmacodynamics properties.
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4. LEGISLATIVE HISTORY
• 1906 Pure Food and Drug Act –establishes regulation of food
and drugs.
• 1938 Food, Drug and Cosmetic Act – introduced safety
standards.
• 1962 Kefauver-Harris Amendments to the FDA&C Act – tightened
safety standards and introduced requirements that drug must be
effective i.e., proof of efficacy.
• 1984 Hatch- Waxman Act - created an abbreviated mechanism
for approval of generic copies of all drugs originally approved
after 1962, by stating that pre-clinical and clinical testing does not
have to be repeated for generics.
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5. WHEN GENERIC DRUG MARKETED
After patent and exclusivity protection
ends
Patent owner waives its rights
FDA requirements are met
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6. B R A N D N A M E D R U G
N D A R E Q U I R E M E N T
1. Labeling
2. Pharma
3. Chemistry
4. Manufacturing
5. Controls
6. Microbiology
7. Testing
8. Animal studies
9. Clinical studies
10. Bioavailability
G E N E R I C D R U G
A N D A R E Q U I R E M E N T
1. Labeling
2. Pharma
3. Chemistry
4. Manufacturing
5. Control
6. Microbiology
7. Testing
8. Bioequivalence
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7. A generic drug is considered
to be bioequivalent to the
brand name drug if :
• The rate and extent of
absorption do not show a
significant difference
from the innovator drug ,
or
• The extent of absorption
does not show a
significant difference and
any difference in rate in
intentional or not
medically significant .
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BIOEQUIVALENCE
8. CLINICAL RESEARCH FOR GENERIC DRUGS
• to demonstrate that the generic medicine is comparable to the
reference medicine so that it can receive a marketing
authorisation.
• to show that the generic medicine produces the same levels
of the active substance in the body as the reference
medicine.
• Bioequivalence studies to assure the therapeutic
equivalence.
• If a generic medicine contains a different salt of the active
substance to the salt used in the reference medicine
• If the medicine is a hybrid, additional tests may be required,
such as the results of clinical trials that test the efficacy of the
medicine.
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9. BE STUDY DESIGN
• Bioequivalence trials are designed to compare the release, absorption,
and elimination of the active ingredient from two formulations of a
product (i.e., the unmarketed generic and corresponding brand-name
product) and, if successful, demonstrate similarity between both within
pre-established, statistically defined, pharmacokinetic parameters.
• Appropriate study protocol including the required number of subjects
and sampling intervals should be determined according to preliminary
studies and previously reported data.
• Design
– Randomized crossover studies
– Parallel designs can be employed..
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11. ANDA
• An Abbreviated New Drug Application (ANDA) contains data which when
submitted to FDA's Centre for Drug Evaluation and Research, Office of
Generic Drugs, provides for the review and ultimate approval of a
generic drug product.
• Generic applicants must scientifically demonstrate that their product is
bioequivalent.
• Scientists demonstrate bioequivalence is to measure the time it takes
the generic drug to reach the bloodstream in 24 to 36 healthy
volunteers. This gives them the rate of absorption, or bioavailability, of
the generic drug, which they can then compare to that of the innovator
drug.
• The generic version must deliver the same amount of active ingredients
into a patient's bloodstream in the same amount of time as the innovator
drug.
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15. INDIAN GENERIC DRUG MARKET
• U S C E N S U S B U R E A U H E A L T H & N U T R I T I O N ( 2 0 0 5 -
2 0 1 0 )
• In 2010 India’s share of the
generic market is about 30%
out of 71.2% and reached
$100 billion.
• In late 2012 40% of DMF’s
were filled by Indian market
in USFDA for supplying
API’s.
• Now India’s share of the
generic market is about to
35%. Hence the contribution
of the Indian pharmaceutical
industry for the growth of
generic drugs in the world is
very high.
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16. RECENT RULES BY FDA FOR GENERIC DRUG
FOR INDIA
Generic drug manufacturers would be able to independently update product labelling (also
called prescribing information or package inserts) with newly-acquired safety
information before the FDA’s review of the change, in the same way brand drug
manufacturers do today. Generic manufacturers would also be required to inform the
brand name manufacturer about the change.
All generic drug makers, including Ranbaxy Laboratories, Cipla, Dr Reddy's Laboratories
and Lupin, are now required to pay a fee to the US drug regulator while seeking
permission to launch their products in the world's largest drug market.
The recently enacted Generic Drug User Fee Act (GDUFA) legislation adds a $20,000-
$30,000 fee at the first time the DMF is referenced in an ANDA. However, the current
rates are in effect only till September 30, 2013, and will be revised every year and is
likely to affect the number of DMFs filed in the coming years from India and around
the world.
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17. CONCLUSION
After the expiry of patent or marketing rights of
the patent drug, generic drugs are marketed.
They are comparable to brand drug in dosage
form, strength, route of administration, quality
and performance characteristics, and intended
use. Generic drugs are available at affordable
prices with maintaining quality. These ‘Generic’
formulations balance public interest as critical
disease like cancer, AIDS etc. India’s
Pharmaceutical market will grew at 9.5% by
2015.
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