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Cyltezo Approval History

FDA Approved: Yes (First approved August 25, 2017)
Brand name: Cyltezo
Generic name: adalimumab-adbm
Dosage form: Injection
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Acute, Crohn's Disease, Maintenance, Ulcerative Colitis, Plaque Psoriasis

Cyltezo (adalimumab-adbm) is an anti-TNF-α monoclonal antibody biosimilar to Humira, approved for the treatment of various inflammatory diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Development History and FDA Approval Process for Cyltezo

Aug 29, 2017Approval FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira
Jul 27, 2017Boehringer Ingelheim Starts Clinical Study on Interchangeability Between its Adalimumab Biosimilar Candidate and U.S.-Formulated Humira
Jan 18, 2017Boehringer Ingelheim Biosimilar Candidate to Humira Accepted for EMA and FDA Regulatory Review
Oct 26, 2016Boehringer Ingelheim’s Adalimumab Biosimilar Candidate Shows Similar Efficacy and Safety Profile to Humira in Pivotal Phase III Study
Oct 28, 2015Boehringer Ingelheim’s Biosimilar Candidate Demonstrated Pharmacokinetic Bioequivalence to Adalimumab

Further information

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