Why Bioequivalence is
Important?
What is Bioequivalence?
• Bioavailability
Bioavailability means the rate and extent to which the active
ingredient or active moiety is absorbed from a drug product and
becomes available at the site of action.
• Bioequivalence Principle
Compares the systemic exposure profile of a test product (Generic)
to that of a reference product (Innovator Brand)
For the test product to be bioequivalent it should exhibit the same
rate and extent of absorption as the reference product compares
the systemic exposure profile of a test product (Generic) to that of
a reference product (Innovator Brand)
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Evolution of Bioavailability
• Response is related to drug dose.
• Response is better related to drug concentration at site of
action.
• Plasma drug concentration reflects drug concentration at site of
action (systemic exposure)
• Bioavailability (BA) determines plasma concentration profile
• Comparison of plasma concentration profile of two formulations
statistically termed as bioequivalence
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Definition - Bioequivalence
Bioequivalence means the absence of a significant difference in
the rate and extent to which the active ingredient or active
moiety in pharmaceutical equivalents or pharmaceutical
alternatives becomes available at the site of drug action when
administered at the same molar dose under similar conditions in
an appropriately designed study.
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Pharmaceutical Equivalent
• Contain identical amounts of the identical API , i.e.,
the same salt or ester of the same therapeutic
moiety, in identical dosage forms
• Different inactive ingredients
• Meet the identical compendial or other applicable
standard of identity, strength, quality, and purity,
including potency and, where applicable, content
uniformity, disintegration times and/or dissolution
rates.
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Pharmaceutical Alternative
• Contain the identical therapeutic moiety, or its
precursor, but not necessarily in the same amount
or dosage form or as the same salt or ester.
• Each such drug product individually meets either
the identical or its own respective compendial or
other applicable standard of identity, strength,
quality, and purity, including potency and, where
applicable, content uniformity, disintegration times
and/or dissolution rates.
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Why Bioequivalence Required?
• To obtain approval for marketing generic
products in regulatory markets (US, EU, AUS
etc.) Eg. ANDAs
• To match clinical trial product and to be
marketed product (Eg. NDAs)
• To match same product manufactured in
different manufacturing plants
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Why Generic Products Required?
A Generic Product
• identical, or bioequivalent to a brand name drug in
dosage form, safety, strength, route of
administration, quality, performance characteristics
and intended use
• is safe and effective alternatives to brand name
prescriptions
• can help both consumers and the government
• reduce the cost of prescription drug
• are currently used in 44% of all prescriptions
dispensed
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What difference bioequivalence make?
NDA Requirements for a ANDA Requirements for
Brand New Generic Product
Product/New Drug
• Chemistry • Chemistry
• Manufacturing • Manufacturing
• Controls • Controls
• Labelling • Labelling
• Testing • Testing
• Animal Studies • Bioequivalence
• Clinical Studies
• Bioavailability
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Global Generic Market
The global generic market
• $47 billions in 2002($250 billions total in 2001)
• $67 billions in 2006 (8% increase annually)
Patent expiry for highly profitable brand drugs
• $37 billions generic competition
Regional Generic market
• About 32% portion of the US market
• About 44% portion of the EU market
• About 10% portion of the Japan market
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Global Generic Market
Western Europe
$17bn
Eastern Europe & Russia:
$10bn
US, Canada: $50bn China: $3bn
Japan: $4bn
Latin America: $2bn Rest of World: $4bn
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GENERIC SHARE MAJOR PHARMA COMPANY
Lupin Bioresearch Centre 12
Regulatory Agencies
CDSCO, India
ICH
FDA, USA
HPFB, Canada
CDSCO
EMA, Europe ANVISA, Brazil
MCC, South Africa TGA, Australia
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Wish You Good Luck!
