Drugs Home > Generic Berinert
There are currently no generic Berinert products available. This is because Berinert is a type of biologic medicine, which means it is made using live cells or organisms. Although certain regulations currently prevent companies from making generic versions of biologics, these laws are beginning to change. Once this happens, companies may be able to manufacture a generic Berinert product.
Berinert® (C1 esterase inhibitor) is a prescription injectable medication used to treat sudden attacks of pain and swelling in people with a rare genetic condition known as hereditary angioedema (HAE). It is given as an injection into a vein (an intravenous, or IV, injection).
Berinert is made by CSL Behring GmbH for CSL Behring, LLC. Because it is a "biologic" medication, Berinert is under different rules and regulations than most other prescription medications. At this time, it is not available in generic form.
A biologic product is a medication made using live cells or organisms. The live cells or organisms are used to make a complex mixture of proteins or molecules, which are then used to make medications or vaccines. Berinert is a biologic because it is a human protein derived from human blood.
Because biologics are complex products made from live cells instead of chemically created like most other prescription medicines, it can be difficult for a manufacturer to make an identical version of a biologic product already on the market. For this reason, previous regulations did not allow generic biologics to be made, and brand-name manufacturers were largely protected from generic competition.
However, regulations are currently changing to pave the way for the availability of generic biologic medications. These products are often called "biosimilars" or "follow-on biologics" instead of generic medicines. Although they are not chemically identical to their brand-name counterparts, biosimilars are expected to have the same effects in the body and, therefore, can be safely substituted for brand-name biologic medications.