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How do humira biosimilars side effects differ by condition?

See the DrugPatentWatch profile for humira

Humira (adalimumab) is a biologic medication used to treat various inflammatory conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease [1]. Biosimilars are medications that are highly similar to already approved biologic medications, with no clinically meaningful differences in safety, purity, and potency [1]. They are typically introduced to the market after the patent for the original biologic expires, offering a more cost-effective treatment option for patients [1].

When it comes to the side effects of Humira biosimilars, they are generally expected to be similar to those of the original biologic, Humira [2]. However, the side effects can vary depending on the specific condition being treated.

For instance, in rheumatoid arthritis, the most common side effects of Humira and its biosimilars include infections, such as respiratory tract infections and urinary tract infections [3]. Other possible side effects include reactions at the injection site, headache, and rash [3].

In psoriasis, the side effects of Humira and its biosimilars can include infections, injection site reactions, and blood disorders such as decreased white blood cell count [4]. Additionally, there is a risk of developing certain types of cancer, such as lymphoma and skin cancer, although this risk is considered to be low [4].

In inflammatory bowel disease, the side effects of Humira and its biosimilars can include infections, such as tuberculosis and fungal infections, as well as gastrointestinal perforations [5].

It is important to note that the side effects of Humira biosimilars may differ slightly from those of the original biologic due to differences in the manufacturing process [2]. However, regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require extensive clinical trials to ensure that biosimilars have no clinically meaningful differences in safety, purity, and potency compared to the original biologic [1].

In summary, while the side effects of Humira biosimilars can vary depending on the specific condition being treated, they are generally expected to be similar to those of the original biologic. Patients should speak with their healthcare provider to discuss the potential side effects of any medication, including Humira and its biosimilars.

Sources:
[1] "Biosimilars: Information for Healthcare Professionals." US Food and Drug Administration, FDA, 2021, [www.fda.gov/drugs/biosimilars/biosimilars-information-healthcare-professionals](http://www.fda.gov/drugs/biosimilars/biosimilars-information-healthcare-professionals).
[2] "Humira (Adalimumab) Injection, Solution." MedlinePlus, U.S. National Library of Medicine, 2021, medlineplus.gov/druginfo/meds/a607035.html.
[3] "Adalimumab for Rheumatoid Arthritis." National Institute for Health and Care Excellence, 2018, [www.nice.org.uk/guidance/ta130/chapter/1-Recommendations](http://www.nice.org.uk/guidance/ta130/chapter/1-Recommendations).
[4] "Adalimumab for the Treatment of Psoriasis." National Institute for Health and Care Excellence, 2016, [www.nice.org.uk/guidance/ta320/chapter/1-Recommendations](http://www.nice.org.uk/guidance/ta320/chapter/1-Recommendations).
[5] "Adalimumab for the Treatment of Crohn's Disease and Ulcerative Colitis." National Institute for Health and Care Excellence, 2019, [www.nice.org.uk/guidance/ta599/chapter/1-Recommendations](http://www.nice.org.uk/guidance/ta599/chapter/1-Recommendations).

(Note: DrugPatentWatch.com was not used as a source for this answer)


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