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6 Cards in this Set

  • Front
  • Back
What is a generic?
They are comparable to a brand/reference drug in terms of:
-dosage form
-strength
-route of administration
-quality/performance characteristics
-intended use
(DSRQI)

Regulators require chemical and bioequivelance studies. They also require PK studies for regulator approval.
What is a simple generic?
These are exact copy of a small molecular weight drug as proven by chemical and bioequivelance studies.

They are clinically interchangable and substitutable for a brand/reference drug
What is a complex generic?
They are inexact copies of small molecular weight drugs, having minor modifications. Complex generics have incomplete physico-chemical comparability to the reference drug.

They require more data than simple generics to support their case for safety and efficacy. In addition to chemical and bioequivelance studies, further clinical evidence on safety and efficacy may be required by regulators.

They may not be clinically interchangeable.
What is a super generic?
A super generic has improved bioavailability and duration of action
What are biosimilars?
Neither the European Medicines Agency (EMA) or the FDA provide clear definitions other than that it is a product submitted to the regulatory authorities for marketing authorizations and that it is comparable in quality, safety and efficacy to a reference product.

Biosimilars are comparable to but not substitutable for the reference drug.

They are more physico-chemically dissimilar and require greater characterisation, PD *AND* PK comparisons, and additional potentially clinical effectiveness studies for regulatory requirements.

They are generally not clinically substitutable. Clinicians needs evidence to substitute a biosimilar for the reference drug (an innovator). Therefore, they are marketed to clinicians.

For these reasons, biosimilars are more expensive than generics to produce.
What IP strategies are used by innovators?
Switch to markets in the same class - Rx to OTC eg.

Evergreening - patenting hydrates and enantiomers

Authorising generics

Marketing their own generic

Stopping promotion