Fresenius Kabi announced today that it has received its first European marketing authorization for a biosimilar. The European Commission granted the drug developer approval for its adalimumab biosimilar, Idacio, for all indications of the reference product, Humira.
Fresenius Kabi announced today that it has received its first European marketing authorization for a biosimilar. The European Commission (EC) granted the drug developer approval for its adalimumab biosimilar, Idacio, for all indications of the reference product, Humira.
“Fresenius Kabi has a heritage of providing high-quality and affordable products to patients and the EC approval of Idaciois an exciting achievement for us, leading to our first entry into the European biosimilars market,” said Michael Schonhofen, PhD, member of the Fresenius Kabi management board and president of the pharmaceuticals and devices division, in a statement announcing the EC’s decision.“We are devoted to putting patients first, and we will focus our efforts to ensure patient access to Idaciowithin Europe.”
The biosimilar was approved on the basis of a data package that included a comparison of the pharmacokinetics, safety, and immunogenicity of the biosimilar in healthy volunteers as well as a phase 3 study in patients with moderate to severe plaque psoriasis that has reported results up to 52 weeks.1
In the phase 3 study, patients were randomized to receive either the biosimilar (n = 222) or the EU-licensed reference product (n = 221). At week 16, patients in the reference arm were re-randomized to continue the reference product (n = 101) or switch to the biosimilar (n = 101). The study’s primary end point was the proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI 75).
The PASI 75 response rate at week 16 was similar in both arms, and the 95% confidence interval (CI) was contained within the prespecified equivalence margin (±18%) to determine equivalent efficacy. The mean percent change from baseline to week 52 in terms of PASI score was similar among all treatment arms, and improvements in Physician Global Assessment, percentage of body surface area affected, and quality of life were also similar among all arms.
The incidence of treatment-emergent adverse events (AEs), serious AEs, treatment-related AEs, AEs of special interest, and treatment discontinuations due to AEs were similar among arms up to week 66, as were the incidences of injection-site reactions and hypersensitivity.
Per the terms of an October 2018 settlement with Humira-maker AbbVie, Fresenius Kabi will be permitted to launch Idacio in the EU marketplace immediately, and Fresenius Kabi will pay AbbVie royalties on the sales of its biosimilar. While the company has not yet received FDA clearance for its adalimumab, it has also agreed with AbbVie that it can market the drug in the United States beginning on September 30, 2023.
In Europe, Idacio joins a host of other biosimilar adalimumab products that have received approval: Hyrimoz, Hulio, Cyltezo, Amgevita (also approved under the name Solymbic), and Imraldi.
Hercogová J, Papp KA, Chyrok V, Ullmann M, Vlachos P, Edwards CJ. Safety, immunogenicity, and efficacy after a single switch from reference adalimumab to the proposed biosimilar MSB11022: Long- term results from a randomized, double-blind, 52-week, phase III study in moderate-to-severeplaque-type psoriasis patients. Presented at the 2019 American Academy of Dermatology Annual Meeting;March 1-5, 2019; Washington, DC: Poster 10554.