Second Biosimilar to Humira Approved
August 25, 2017 – The U.S. FDA has approved Cyltezo™ (adalimumab-adbm), manufactured by Boehringer Ingelheim, for the treatment of adults with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. Cyltezo is also indicated for treatment of children at least four years of age who have polyarticular juvenile idiopathic arthritis. It is the second biosimilar for AbbVie’s Humira® (adalimumab) to receive FDA approval. The first, Amgen’s Amjevita™ (adalimumab-atto), was approved in September of 2016. However, both Cyltezo and Amjevita are not expected to be launched for at least two more years due to ongoing patent litigation.
Recommended dosing for Cyltezo varies depending on the indication. The drug is expected to be available as a 40mg/0.8mL solution in single-dose prefilled glass syringes for subcutaneous injection. Like other biosimilars, Cyltezo is not considered a generic medication, and is not atomically interchangeable with Humira or Amjevita.
Cyltezo carries a black box warning notifying patients of the risk of serious infections, including tuberculosis, fungal infections, and bacterial sepsis. Lymphomas and other cancers have been reported in children and adolescents treated with adalimumab products. Patients should be tested for tuberculosis prior to initiating Cyltezo, and periodically during therapy.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.