Generics And Innovators

An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.

1. Genericsand Innovators
Prof. Sachin N. Kothawade
Department of Pharmaceutics,
SitabaiThiteCollege of Pharmacy,
Shirur

2. What Is Innovator Drugs?
Aninnovatordrugisthefirstdrugscreatedcontainingits
specificactiveingredienttoreceiveapprovalforuse.Itis
usuallytheproductforwhichefficacy,safetyandquality
havebeenfullyestablished.Whenanewdrugisfirstmade,
drugpatentusuallywillbeacquiredbythefounding
company.Mostdrugpatentsareprotectedupto20years.
Duringthepatentperiod,othercompaniescannotmakeor
sellthesamedruguntilthepatentexpires.

3. What Is Generic Drugs?
Agenericdrugismadeofthesameactiveingredientas
itsinnovatordrug.Anactiveingredientisthechemical
containedinsideadrugthatmakesitwork.Inother
words,thepharmacologicaleffectofagenericdrugis
exactlythesameasthoseofitsinnovatorcounterpart.
Othercompaniescanmanufacturesthegenericdrugs
whenpatentexpires.

4. Are innovator drugs and
generic drugs similar?
Therearesimilaritiesbetweengenericandinnovator
drug,suchas:
❑Activeingredient
❑Strength(dose)
❑Therapeuticeffect
❑Sideeffects
❑Howtotake

5. Examples of Innovator And
Generic Drugs
Active ingredientsInnovator Generic
Ranitidine HCL Zantac X’tac
Mefenamic acid Ponstan Mefetab
Piroxicam Feldene Apo-Piroxicam

6. Are generic drugs as safe as
the innovator drugs ?
DrugControlAuthority(DCA)inMalaysia,imposes
stringentevaluationforallproductsincludegeneric
drugstobelistedinMalaysiatoensurequality,safety
andeffectiveness.GenericDrugsarerequiredto
undergobioequivalence(BE)studiestoensurethe
therapeuticeffectofgenericdrugsareequivalent(can
beinterchanged)withtheinnovatordrugbeforedrugs
areallowedtobemarketedinMalaysia..Therefore,
registeredgenericdrugsareassafeandeffectiveas
innovatordrugs.

7. Myths of Generic Drugs
Somemythsthatareoftenassociatedwithgeneric
drugs:
✓Genericdrugsarenotassafeasinnovators
✓Genericsdrugsarenotaseffectivesasinnovator
✓Genericsdrugstakelongertimetoactinthebody

8. Myths of Generic Drugs
✓Genericdrugsusethesameactiveingredientsas
innovatordrugsandworkthesameway.Sotheyhave
thesamerisksandbenefitsastheinnovatordrugs.
✓Genericdrugsmaylookdifferentbecauseofcertain
inactiveingredients,suchascolorsandflavoringsagents,
maybedifferent.Theseingredientsdonotaffectthe
safety,effectivenessorperformanceofthegenericdrug.
✓So,there’snotruthinthemythsthatgenericdrugsare
inferiorinqualityascomparedtoinnovatordrugs.

9. Generic Drug Issues
➢Innovatordrugsaremoreexpensivebecausethecompanywhofirst
manufacturesthedrugspendslargeamountofmoneyinresearchto
developthenewdrugwhichincludesclinicaltrials,marketingand
promotionofthedrugs.
➢Genericsdrugsarecheaperastheirmanufacturesarenotrequiredto
demonstratetheirefficacyandsafetythroughclinicaltrialsasthese
havealsobeenestablishedbytheinnovators.
➢However,genericsdrugsstillneedstoconformtosamestandardof
quality,safetyandefficacyrequiredoftheinnovators.Inaddition,
whenthepatentofadrugexpired,therewillbemorecompany
producegenericdrugswhichcreatecompetitionandmayreducethe
costofadrug.

10. R&Doverview
Post
marketing
safety
surveillance
Pre
clinical
animal
tests
Clinical
human
studies
Discovery&
synthesis
??years 1-3years 2-10years 2-12years
NCE
marketing
approval
Generic
marketing
approval

11. Globaluseofgenerics
⚫USA:50%
⚫Germany:60%
⚫UK:60%
⚫Australia:30%
⚫Malaysia:40%

12. InnovatorVsGeneric
Attribute Innovator Generic
Qualitysystems ? Prefer
cGMP Yes
⚫Sourcecountryimportant
Yes
⚫Sourcecountryimportant
TestStandards Yes Monograph
Stability Yes Yes
Efficacy Yes Yes
⚫butmaynotbe
interchangeable
Safety Yes Yes
⚫AEasinnovator
⚫superBApotential
Price/value $$$ $
Other–
pkg,appearance,etc
? ?
Regulatorycompliance Yes Yes

13. InnovatorVsGeneric
⚫Personalpreference
⚫Pricemaybemoreofconcerntosome
patientstomanagehealthexpenditure
⚫Lookfor‘reliable’manufacturer
⚫BEisimportantforpatientsswitchingfrom
innovatortogeneric

14. Pointstoremember
⚫Notallgenericproductsbadandonlyinnovatorgood
⚫Notallgenericproductsgood
⚫BEimportantespeciallyforproductsforserious
diseases&narrowsafetymargins
⚫Reputablemanufacturerimportant
⚫Priceisimportant
……butmustbebalancedwithpatient’scare