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08/02/2019 12:47:21
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EMA approval for adalimumab biosimilars Idacio and Kromeya

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 [4].


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