Solymbic (adalimumab)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- adalimumab
- Company
- Amgen Europe B.V.
- Status
- Withdrawn
- Therapeutic area
- Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa; Psoriasis; Arthritis, Rheumatoid
- CHMP opinion
- Thu 15 Dec 2016
- EU approval
- Wed 22 Mar 2017
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/004373
- ATC
- L04AB04
- Official record
- www.ema.europa.eu
Indication
Please refer to section 4.1 of the Summary of product characteristics in the product information document.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Yuflyma Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Hulio Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Amgevita Authorised · Amgen Europe B.V.
- 🇪🇺 Hukyndra Authorised · Stada Arzneimittel AG
- 🇪🇺 Libmyris Authorised · Stada Arzneimittel AG
- 🇪🇺 Hefiya Authorised · Sandoz GmbH
- 🇪🇺 Imraldi Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Hyrimoz Authorised · Sandoz GmbH
- 🇪🇺 Amsparity Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Halimatoz Withdrawn · Sandoz GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.