Generic Pulmozyme is currently not available because the laws surrounding the manufacture of generic biologic medications do not allow it. These laws will likely be changed in the future, although whether these medications will be less expensive than the brand-name equivalents is not clear. If it does become available, generic Pulmozyme will probably be used to help treat cystic fibrosis, as with the brand-name version.
Generic Pulmozyme: An OverviewPulmozyme® (dornase alfa) is a prescription medication used in the treatment of cystic fibrosis. It is a synthetic version of a naturally occurring human enzyme.
Pulmozyme is manufactured by Genentech, Inc. Technically, Pulmozyme is considered a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this time, generic biologics, including generic Pulmozyme, are not allowed to be made.
When Will Generic Pulmozyme Be Available?This is a difficult question to answer. Unless the laws and rules are changed, generic Pulmozyme will never be available. However, it is likely that these rules and laws will be changed in the future.
Biologics and Generic DrugsBiologics are products that are made using live cells or organisms. The cells or organisms are used to produce certain complex proteins or molecules that are used as medications. As a result, the medications are known as "biologics" or "biopharmaceuticals."
When the patents for regular drugs expire, companies who make generic drugs can apply to make generic versions. These companies need to submit information proving that their product is the same as the brand-name version, but they do not have to repeat all of the human studies that show the drug to be safe and effective. Human studies are expensive and time-consuming, and generic medications are less expensive because they do not need all the human studies.
However, biologics are governed by a different set of laws. Currently, under these laws, there is no way for a generic biologic to be approved, unless the manufacturer completes all of the human studies necessary to approve a brand-new drug. Because such studies are extremely expensive, it is likely that a generic biologic would not be any less expensive than the brand-name product. Essentially, if a generic biologic were to be approved, it would not really be a generic version, but a new and separate drug that would not be equivalent to the brand-name product.
Recently, there has been much interest in changing these laws, and it is likely that generic biologics will be allowed in the near future.