BAD VILBEL, Germany & REYKJAVIK– STADA is offering Hukyndra®, the Alvotech-developed high-concentration, citrate-free formulation biosimilar of adalimumab to patients and their caregivers in selected European countries, including France, Germany, Finland, and Sweden. Launches in further European countries are scheduled over the coming months.
The biosimilar to Humira®, with its 100 mg/mL adalimumab in 40 mg/0.4 mL custom-designed pre-filled auto-injector pen as well as 40 mg/0.4 mL and 80 mg/0.8 mL pre-filled syringe presentations, offers a comprehensive range of biosimilar presentations and devices designed with ease of patient use in mind.
Adalimumab marks the first biosimilar to be commercialized by STADA under a development and manufacturing partnership with Alvotech that, in total, spans seven biosimilars and biosimilar candidates across autoimmunity, oncology, and ophthalmology indications1. The partners’ goal is to make available these European-made biosimilars to European patients and caregivers over the coming months and years. The pipeline includes the AVT04 ustekinumab biosimilar candidate, for which Alvotech recently announced clinical study results demonstrating therapeutic equivalence to the reference product Stelara®.
Head of Global Specialty, EVP, Bryan Kim commented: “Our Hukyndra high-concentration alternative to Humira® – STADA’s fifth marketed biosimilar after epoetin zeta, pegfilgrastim, teriparatide and bevacizumab – adds to STADA’s growing portfolio of biosimilar and specialty care assets aimed at broadening patient access, adding value and supporting sustainable European healthcare systems.”
“Although biosimilar medicines have been marketed in Europe for over 16 years, significant unmet needs exist for patients to access key therapies,” Kim continued. “Through the combination of Alvotech’s scientific and manufacturing expertise with STADA’s pan-European commercial excellence, we can deliver a portfolio of high-quality biologic products to patients in Europe, with a goal of expanding access to critical therapies. Positively impacting the lives of European patients with inflammatory disorders with our high-concentration, citrate-free alternative to Humirais fully in line with STADA’s purpose of caring for people’s health as a trusted partner.”
Anil Okay, Alvotech’s chief commercial officer, commented: “We are thrilled to take this important step with STADA into multiple European markets. The commercial partnership with STADA allows Alvotech to leverage its strengths as a purpose-built R&D and manufacturing platform, singularly focused on biosimilars, which are of vital importance for healthcare systems globally.”
In November 2021, STADA received approval from the European Commission for the Hukyndra high-concentration 100 mg/mL adalimumab biosimilar in the 27 EU member countries plus Norway, Iceland and Liechtenstein. Developed by Alvotech under the AVT02 name, the biosimilar is authorized for all of the reference product’s indications, treating a range of inflammatory conditions in adults and children, including arthritis, psoriasis, Crohn’s disease and ulcerative colitis. In April 2022, Alvotech and STADA announced that they had paved the way to launching their Hukyndra biosimilar to Humira® by resolving all intellectual property disputes in Europe with the manufacturer of the reference product.
Manufactured entirely in Europe by Alvotech, STADA’s Hukyndra biosimilar offers an alternative to Humira with no clinically meaningful differences in terms of safety, quality and efficacy. Hukyndra is a patient-friendly option because of attributes that correlate with less injection-site pain, including an administered volume that is half of low-concentration adalimumab biosimilars, a citrate-free buffer and a thin 29G needle.
STADA is supporting Hukyndra launches in individual national markets through tailored educational materials and well as dedicated patient support programs.
