Generic medications go through a rigorous review process to receive FDA approval. The FDA ensures a generic medication provides the same clinical benefit and is as safe and effective as the brand-name medicine that it duplicates.12
| Reference List Drug | Approved AP Generic | Therapeutically Equivalent | |
|---|---|---|---|
| Name | Firazyr® | lcatibant Injection | |
| Condition of Use (Indications) | It is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older | It is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older | |
| Drug Form | Sterile solution | Sterile solution | |
| Route of Administration | Subcutaneous injection in the abdominal area | Subcutaneous injection in the abdominal area | |
| Active Ingredient | Icatibant Acetate | Icatibant Acetate | |
| Strength | 30 mg per 3 mL | 30 mg per 3 mL | |
| Excipients | Sodium Chloride, Water for lnjection USP, Glacial Acetic Acid, Sodium Hydroxide, NF | ||
*FIRAZYR® is a registered trademark of Shire, a Takeda company.
Generic medications go through a rigorous review process to receive FDA approval. The FDA ensures a generic drug is a medication created to be the same as an already marketed brand-name product in:
A generic FDA-approved drug uses the same active ingredient, has the same intended use, and is taken the same way (oral, injection, patch, etc.) as its brand.
These similarities help to demonstrate that the generic medicine works in the same way and provides the same clinical benefit as the brand-name version. An approved AB generic medicine should be considered substitutable.
The FDA Generic Drugs Program conducts a thorough review to be sure generic medicines meet the standards mentioned above. In addition, it inspects 3,500 manufacturing plants a year and continues to monitor drug safety after the generic medicine is in the market.
When any product is mass produced, there can be a certain level of difference between the batches. This is true of both brand drugs and generic medicines. FDA defines how much variability is acceptable.
Even though generic medicines have the same therapeutic effect as the branded product, they are usually sold at a substantial discount (80-85% less). Generics are not required to invest in the upfront clinical research that the brand did to get approved. This results in a significant savings to consumers.
Fresenius Kabi’s generic Icatibant Injection is an FDA-approved, fully substitutable equivalent to Firazyr®*
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, clinical nutrition, and specialty pharmaceuticals. Our products and programs are designed to help care for critically and chronically ill patients.
References
*FIRAZYR® is a registered trademark of Shire, a Takeda company.
