Sandoz has unveiled its Hyrimoz (adalimumab) citrate-free high-concentration formulation (HCF:100mg/mL), a biosimilar of reference medicine Humira, in Europe.
Hyrimoz HCF is marketed in a 50mg/mL version to treat all indications covered by Humira. These include Crohn’s disease, rheumatic diseases, plaque psoriasis, ulcerative colitis, uveitis and hidradenitis suppurativa.
The updated formulation enables a 50% reduction in injection volume for patients who require dosages of 80mg/mL or above.
The Hyrimoz SensoReady pen is used to administer the HCF formulation of the medicine.
Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody that acts on tumour necrosis factor-alpha (TNF-a).
The company launched Hyrimoz HCF in the US in July 2023.
The introduction of the new formulation of Hyrimoz bolsters the biosimilar portfolio of Sandoz in the immunology sector.
Other biosimilars from the company in immunology include Erelzi (biosimilar etanercept), Zessly (biosimilar infliximab) and Rixathon (biosimilar rituximab, including a rheumatoid arthritis indication).
Sandoz Europe president Rebecca Guntern stated: “People living with chronic inflammatory conditions can experience debilitating effects on daily life.
“The launch of Hyrimoz HCF in Europe is a key milestone in offering an additional treatment option to those that need it, and showcases our unwavering commitment to expanding access to high-quality medicines.”
Sandoz recently inaugurated two new facilities in Europe to provide continued access to quality antibiotics and biosimilar development.
A facility in Kundl, Austria, will focus on manufacturing penicillin while a plant in Holzkirchen, Germany, will develop new biosimilars.
Sandoz separated from Novartis and began trading on the SIX Swiss Exchange as a separate entity in October 2023.
Through the Sandoz spin-off, Novartis intends to become a focused medicines company to develop innovative treatments.
In September 2023, the European Commission granted marketing approval for the company’s Tyruko (natalizumab), a biosimilar version of Biogen’s Tysabri, for a number of multiple sclerosis-related settings.
