Because Simponi (golimumab) is considered a "biologic" medication, it is subject to rules and laws that prevent any generic versions from being made. These regulations are slowly changing, but there is no precise timetable. Therefore, it's impossible to say at this time when a generic form of Simponi could become available.
Can I Buy Generic Simponi?Simponi™ (golimumab) is a prescription medication that belongs to a group of drugs known as tumor necrosis factor blockers. It is approved for treating ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, and rheumatoid arthritis. It is injected just under the skin (subcutaneously) once a month.
Simponi is manufactured by Centocor Ortho Biotech, Inc. Technically, it is considered a "biologic" and, therefore, is under different rules and laws than most other medications. At this time, it is not available in generic form.
What Is a Biologic?
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.
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. 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 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.