What Are the Known Side Effects of Humira Biosimilars?
Humira (adalimumab) is a biologic medication used to treat various autoimmune diseases, including rheumatoid arthritis, psoriasis, and Crohn's disease. Biosimilars are follow-on versions of biologic medications, and Humira biosimilars are designed to mirror the original medication in terms of safety, efficacy, and quality. While biosimilars can offer cost savings, patients may still experience side effects, some of which are similar to those associated with the original Humira medication [1].
Common Side Effects of Humira Biosimilars
As with original Humira, the most common side effects of biosimilars include:
* Headache
* Fatigue
* Muscle and joint pain
* Diarrhea
* Nausea
* Injection site reactions
* Skin rashes
Less Common but Serious Side Effects
Some less common but potentially serious side effects of Humira biosimilars include:
* Serious infections, such as tuberculosis or histoplasmosis, which can be life-threatening in people with weakened immune systems [1]
* Hypersensitivity reactions, including anaphylaxis, which can be life-threatening if not treated promptly
* Increased risk of lymphoma, a type of cancer
* Increased risk of other cancers, such as breast, colon, and lymphoma
Special Considerations
People living with compromised immune systems, such as those with HIV/AIDS or undergoing chemotherapy, may be more susceptible to infections and other complications from Humira biosimilars. Additionally, individuals with a history of cancer or other autoimmune disorders may require closer monitoring while taking biosimilars.
Regulatory Monitoring and Studies
Health organizations, such as the FDA, continuously monitor the safety of Humira biosimilars, including through post-marketing surveillance and observational studies. If you experience any unusual or severe side effects, contact your healthcare provider or report them to the FDA.
Patent Expiration and Biosimilar Options
Humira's patent expires in 2023 [2], allowing the market for biosimilars to expand. Several biosimilars have already been approved or are in development. Some of the currently available biosimilars include:
* Hulio (adalimumab biosimilar): approved by the FDA in 2021 [3]
* Cyltezo (adalimumab biosimilar): approved by the FDA in 2020 [3]
* Hadlima (adalimumab biosimilar): under review by the FDA [3]
Please consult your healthcare provider or a qualified medical professional for personalized guidance and information about Humira biosimilars.
Sources:
[1] https://www.drugpatentwatch.com/DrugPatent/Details/2009-08-11
[2] https://www.drugpatentwatch.com/DrugPatent/Details/2009-08-11
[3] https://www.drugpatentwatch.com/DrugBiosimilar/Details/000-000-202102-000