Novartis’ Sandoz is pushing to wipe out an advantage AbbVie’s Humira enjoys over its biosimilar rival in the EU, securing regulatory acceptance of a filing for a high-concentration formulation of the autoimmune treatment.
Like Humira, Sandoz’s biosimilar Hyrimoz was originally approved as a 50-mg/mL formulation. AbbVie later received European Medicines Agency (EMA) approval for prefilled syringes and pens that contain 100 mg/mL, enabling patients on 80 mg of Humira to administer a single 0.8-mL injection to manage their condition. Patients can also access 0.2-mL and 0.4-mL versions of the 100-mg/mL formulation.
AbbVie markets its 100-mg/mL, citrate-free Humira products as reducing the volume of liquid injected and the pain patients experience immediately following injection. Those features give Humira potential advantages over Sandoz’s 50-mg/mL Hyrimoz.
Sandoz is working to close the gap. Late last week, the off-patent medicine specialist said the EMA has accepted an application for its high-concentration, 100-mg/mL Hyrimoz for regulatory review. The new formulation is free from the excipient citrate and uses the same autoinjector as the 50-mg/mL version of Hyrimoz. Sandoz said the formulation could reduce the number of injections for some patients.
To support the submission, Sandoz ran a phase 1 pharmacokinetic bridging study that compared the 50-mg/mL and 100-mg/mL versions of Hyrimoz. The study showed the new formulation has comparable pharmacokinetics and similar safety and immunogenicity to its lower-concentration predecessor.
Sandoz’s push for approval of the higher-concentration Hyrimoz HCF comes as it seeks to increase the use of biosimilars by 30% by the end of the decade. To achieve that goal, the company recently began a campaign designed to help address potential barriers to uptake of off-patent biologic copycats. Sandoz is forecasting that biosimilar launches will drive “material growth” from 2024 as it seeks to capitalize on the loss of exclusivity for products with $80 billion in sales.