Generic C1 Esterase Inhibitor
There are no generic C1 esterase inhibitor products available at this time. This medication is a biologic medicine, which means it is made using live cells or organisms. Current regulations prevent companies from making generic versions of biologics. However, these laws are beginning to change, so a generic C1 esterase inhibitor might become available at some point in the future.
C1 esterase inhibitor (Berinert®, Cinryze®) is a prescription medicine approved to treat people with a rare genetic condition known as hereditary angioedema (HAE). HAE can cause sudden bouts of swelling and pain in the body.
C1 esterase inhibitor comes in two forms: Berinert and Cinryze. Berinert is made by CSL Behring GmbH for CSL Behring, LLC. Cinryze is made by Sanquin Blood Supply Foundation for ViroPharma Biologics, Inc.
This drug is considered a "biologic" product and is, therefore, under different rules and regulations than most other prescription medications. At this time, C1 esterase inhibitor is only available as brand-name products.
A biologic is a medical product made from living cells or organisms. The living cells or organisms are used to make a complex mixture of proteins or molecules, which are then made into medical products, such as medicines, vaccines, or blood products. C1 esterase inhibitor is a biologic because it is a human protein derived from human blood.
Because biologics are complex products made from living cells, instead of chemically created like most other prescription medicines, it can be difficult for a generic manufacturer to make an identical version of a biologic product already on the market. Therefore, in the past, 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 generic biologics 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.