Breyna™ – The First FDA Approved Symbicort® Generic With a 0.1 Gram Problem

PAAS Tips:

• The Breyna™ inhaler comes in a package size of 10.3 gm, which is different than Symbicort® and its authorized generic that come in a package size of 10.2 gm
  • PAAS would recommend the pharmacy obtain a new prescription for Breyna™ due to the different package sizing. If a prescriber writes for Symbicort^® 10.2 gm, one inhaler with 5 refills, a total of 61.2 gm was authorized. If a pharmacy bills and dispenses all 6 fills using the Breyna™ NDC, this would be 61.8 gm total. If audited, a PBM could recoup the last claim due to dispensing an overbilled quantity that was not authorized.
• See our updated Inhaler Chart on the PAAS Portal
• What is an Authorized Generic?
  • An authorized generic is the exact same drug product as the brand, including both active and inactive ingredients
  • It is often made in the same facility and on the same equipment as the brand with the generic name on the label instead of the brand name, and sold at a lower price
  • Note that the FDA approval numbers are the same for the brand and the authorized generic
  • Considered to be therapeutically equivalent to its brand-name drug because it is the same drug
• What is a Regular Generic (ANDA)?
  • An ANDA generic is the same brand-name drug in active ingredients, conditions of use, dosage form, strength, route and for the most part labeling, but may have certain minor differences such as inactive ingredients
  • Typically developed and made by a company other than the company that makes the brand-name drug.
  • Has a different FDA application number than the brand name and authorized generic
  • Must confirm bioequivalence to the brand name
• See the FDA website for additional discussion on Authorized Generics