Date: 2017-11-10
Type of information: Granting of a Market Authorisation in the EU
Product name: Cyltezo® - BI 695501
Compound: biosimilar version of Humira®(adalimumab) - adalimumab-adbm
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases - Digesti
Action mechanism:
- monoclonal antibody/biosimilar product/TNF alpha inhibitor. Cyltezo® (adalimumab-adbm) is a biosimilar version of the monoclonal antibody adalimumab (Humira®). Adalimumab specifically binds to tumor necrosis factor (TNF)-alpha.
Company: Boehringer Ingelheim (Germany)
Disease:
- ankylosing spondylitis, Crohn’s disease, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, hidradenitis suppurativa, uveitis.
Latest news:
- • On 14 September 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Cyltezo®, intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn's disease, ulcerative colitis and uveitis. Cyltezo® will be available as a 40 mg solution for injection.
- • On August 25, 2017, the FDA approved Cyltezo® (adalimumab-adbm) for multiple indications. This is the second FDA-approved biosimilar to U.S.-licensed Humira (the first one is Amgen's Amjevita®/Amgevita® approved in September 2016 in the US and in March 2017 in the EU).
- • On January 18, 2017, Boehringer Ingelheim announced that BI 695501, its adalimumab biosimilar candidate to Humira®*, has been accepted for regulatory review by the European Medicines Agency (EMA) and the FDA. Top-line results from the completed Phase III study for BI 695501 in patients with active rheumatoid arthritis were announced on October 26, 2016.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-08-25
UE authorization: 2017-11-14
Favourable opinion UE: 2017-09-14
Favourable opinion USA: 2017-11-10
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
