Solymbic

Withdrawn

This medicine's authorisation has been withdrawn

adalimumab

Overview

On 15 June 2018, the European Commission withdrew the marketing authorisation for Solymbic (adalimumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Amgen Europe B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Solymbic was granted marketing authorisation in the EU on 22 March 2017 for treatment of rheumatoid arthritis, enthesitis-related arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and non-infectious uveitis. 

Solymbic is a biosimilar medicine of Humira. There are other biosimilar medicinal products of Humira authorised and marketed in the EU. Solymbic was a duplicate application to Amgevita, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Amgevita. 

The European Public Assessment Report (EPAR) for Solymbic is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Solymbic : EPAR - Summary for the public

Product information

Solymbic : EPAR - Product Information

Solymbic : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Solymbic
• Active substance:
  adalimumab
• International non-proprietary name (INN) or common name:
  adalimumab
• Therapeutic area (MeSH):
  • Arthritis, Psoriatic
  • Spondylitis, Ankylosing
  • Crohn Disease
  • Colitis, Ulcerative
  • Hidradenitis Suppurativa
  • Psoriasis
  • Arthritis, Rheumatoid
• Anatomical therapeutic chemical (ATC) code:
  L04AB04

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Please refer to section 4.1 of the Summary of product characteristics in the product information document.

Authorisation details

• EMA product number:
  EMEA/H/C/004373
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation holder:
  Amgen Europe B.V.

  Minervum 7061 ; 4817 ZK Breda ; Netherlands

• Opinion adopted:
  15/12/2016
• Marketing authorisation issued:
  22/03/2017
• Withdrawal of marketing authorisation:
  15/06/2018
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Solymbic : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Solymbic : EPAR - Public assessment report

Reference Number: EMA/106921/2017

CHMP summary of positive opinion for Solymbic

AdoptedReference Number: EMA/CHMP/41575/2017