EMA approval for adalimumab biosimilars Idacio and Kromeya

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

EMA approval for adalimumab biosimilars Idacio and Kromeya

Biosimilars/News | Posted 08/02/2019 0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2019 that it had recommended granting marketing authorization for the adalimumab biosimilars Idacio and Kromeya.

Both Idacio and Kromeya are produced by Fresenius Kabi, the generics unit of German healthcare giant Fresenius. The company had reported positive phase I results for its candidate adalimumab biosimilar (MSB11455) in October 2018 [1].

The CHMP has recommended that Idacio and Kromeya be approved for the treatment of certain inflammatory and autoimmune disorders, including axial spondyloarthritis, Crohn’s disease, hidradenitis suppurativa, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis.

Eight adalimumab biosimilars have already been approved for use in the European Union (EU). Amgen’s Amgevita and Solymbic received European Commission (EC) approval in March 2017, Imraldi, produced by Samsung Bioepis, received approval in August 2017, Boehringer Ingelheim’s Cyltezo received approval in November 2017, Sandoz’s Halimatoz, Hefiya and Hyrimoz received approval in July 2018 and Hulio produced by Mylan/Fujifilm Kyowa Kirin Biologics received approval in September 2018 [2].

Fresenius Kabi acquired Merck KGaA’s biosimilars business in September 2017 after Merck KGaA decided to divest its biosimilars business [3]. Fresenius Kabi is also developing a pegfilgrastim biosimilar [2] and reported positive phase I results in October 2018 [1].

EMA approval for adalimumab biosimilar Imraldi

References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Fresenius Kabi’s pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 8]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-Fresenius-Kabi-s-pegfilgrastim-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
3. GaBI Online - Generics and Biosimilars Initiative. Fresenius Kabi acquires Merck KGaA’s biosimilars business [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 8]. Available from: www.gabionline.net/Pharma-News/Fresenius-Kabi-acquires-Merck-KGaA-s-biosimilars-business

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.