Product Analogs Help Manufacturer Strategy

Prior to launching a new product, pharmaceutical manufacturers need to understand how a new product will be linked to existing products in drug databases in order to realize the implications on pharmacy product selection and substitution. Drug product selection and substitution in the pharmacy are based on both pharmaceutical equivalence and therapeutic equivalence.

Pharmacy dispensing systems incorporate drug databases such as Medi-Span and First Databank, which link products based on pharmaceutical equivalence. Pharmaceutical equivalence is defined as having the same active ingredient, strength, dosage form, and route of administration. Products may be linked differently within drug databases based on varied interpretations of these four characteristics. For example, dosage form technology and product release mechanisms may be classified differently by drug database providers.

Therapeutic equivalence often guides pharmacists when identifying appropriate product substitution. The FDA determines therapeutic equivalence and publishes the results in the Orange Book. Therapeutically equivalent products are pharmaceutically equivalent and have an “A” equivalence rating in the Orange Book. Over forty states rely on the Orange Book to guide pharmacists on generic substitution.

PHSI works with drug manufacturers to identify product analogs with similar product linking characteristics such as dosage form and route of administration. This research helps manufacturers understand how their product will likely be classified and linked in pharmacy systems prior to commercialization.  Products with unique dosage form technology may still have challenges getting dispensed, especially if pharmacists are not aware of differences in this technology and drug database coding limitations.  Additional challenges with product substitution can be identified through market research conducted by PHSI. Once the analogs are understood, manufacturers are better able to develop strategies and refine forecasts prior to product launch to be prepared for these challenges.

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