In late 2010, the United States Food and Drug Administration (FDA) recommended that Avastin's breast cancer approval be removed. Studies have not shown the drug to increase survival in people with breast cancer, and there is not sufficient benefit to outweigh the risks.
This action does not affect Avastin's approval for other uses. Healthcare providers may still use Avastin to treat breast cancer, although they will be doing so in an "off-label" fashion.
Generic Avastin: An Overview
) is a medication used in the treatment of various types of cancer. It is part of a group of medications known as monoclonal antibodies.
Avastin is manufactured by Genentech, Inc. Technically, Avastin is considered a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this time, generic versions of biologics, including generic Avastin, are not allowed to be made.
When Will Generic Avastin Be Available?
This is a difficult question to answer. Unless the laws and rules are changed, generic Avastin will never be available. However, it is likely that these rules and laws will be changed in the future.
Understanding Biologics and Generic Medicines
Biologics 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. These medications are known as "biologics" or "biopharmaceuticals."
When the patents for regular drugs expire, drug companies 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 drug 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 is not 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.