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Our Executive Clinical Pharmacy Team discusses Authorized Generics (AGs) and their impacts across the marketplace. 

 

Topics included in this episode:

  • Differences between AGs and traditional generic drugs

  • Manufacturer motivations for launching AGs

  • Examples of current AGs, positioning tactics, and potential launches

  • Impact on price erosion and uptake

  • Forecasting implications

  • Payer considerations for various lines of business

  • And more

 

IPD'S DRUG & CLINICAL REVIEW:

UNDERSTANDING AUTHORIZED GENERICS

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“What are the key differences between authorized generics (AGs) and traditional generic drugs?”

 

“Basically the FDA approval for an authorized generic is not required because the brand drug was approved through a new drug application (NDA), and all that the FDA requires is that the NDA holder notify them if it decides to market an AG. For a traditional generic, however, the manufacturer does have to submit an abbreviated new drug application (ANDA) to prove that it contains the same active ingredients and has the same conditions of use, dosage form, strength, route of administration, and labeling. All of this holds true for an AG because again, it is essentially the brand drug, just being marketed as an AG. As far as the traditional generic, they must prove to the FDA that they are the same. As far as marketing goes, an AG can be marketed by the brand name manufacturer or another company with permission from the brand name manufacturer.”