Sandoz, a Novartis division, has announced the US launch of its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) – a biosimilar version of AbbVie’s Humira (adalimumab).
Hyrimoz HCF (100mg/mL) is approved to treat all indications that are no longer covered by the reference medicine regulatory exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa.
Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are highly similar to an existing FDA-approved reference product.
The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs.
Hyrimoz was approved by the FDA in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction compared to the original concentration and can decrease the number of injections required for people who need at least 80mg dosing.
Sandoz also outlined that the HCF has the same auto-injector as Hyrimoz 50mg/mL, providing patients with a familiar experience.
The HCF was approved in March this year, with the submission supported by results from a phase 1 pharmacokinetic bridging study that compared it to the 50mg/mL.
The study met all primary endpoints, showing comparable pharmacokinetics and similar safety and immunogenicity between the two dose concentrations.
Keren Haruvi, president North America, Sandoz, said: “This is an important moment for Sandoz and for the millions of patients living with chronic inflammatory diseases in the US. With this launch, we are entering the US immunology market and continuing to fulfill our commitment to expand access to important medicines for patients.”
Haruvi added that Hyrimoz “offers another treatment option for those who need adalimumab but might have previously been unable to access or afford this critical medicine”.
Sandoz announced a partnership with Just-Evotec Biologics in May aimed at developing and manufacturing multiple biosimilar candidates with an option for expansion.
The multi-year collaboration grants Sandoz access to Just-Evotec Biologics’ proprietary drug substance development platform and manufacturing technology, which Sandoz will use to expand its current pipeline of biosimilars from 15 to about 24 candidates and develop its early-stage pipeline.
Πηγή: pmlive.com
