FDA approves higher concentration of Hyrimoz, Humira biosimilar

The new 100 mg formulation is due to be available in US in July

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by Patricia Inacio PhD |

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A high concentration formulation of Sandoz’s biosimilar Hyrimoz (adalimumab-adaz) has been approved by the U.S. Food and Drug Administration (FDA) to treat ankylosing spondylitis (AS) and other conditions.

The new citrate-free formulation (100 mg/mL) is expected to be available on July 1, according to Sandoz. It’s approved for seven indications covered by its reference medicine, Humira — AS, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis — two forms of inflammatory bowel disease — and plaque psoriasis.

Hyrimoz was first approved in the U.S. for AS in 2018 at a concentration of 50 mg/mL. Administered as an under-the-skin injection, the more concentrated version delivers the same active ingredient, adalimumab, in a smaller volume. A biosimilar is a medication designed to have the same properties as the reference (biological) medicine and to be similar in safety and effectiveness.

“As one of the first adalimumab high-concentration formulation biosimilars approved in the U.S., Hyrimoz HCF [high concentration formulation] has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” Keren Haruvi, president of Sandoz US and head of North America, said in a press release. “Sandoz has more than two decades of experience researching, developing, and bringing biosimilars to markets across the globe. We are excited to continue this leadership by providing patients with another treatment option to help manage their chronic conditions.”

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The FDA’s decision was based on the results of a Phase 1 bridging study that compared the 50 mg/mL dose to the high concentration. The study achieved all its primary goals, with the new formulation showing similar pharmacokinetics — the movement of a medicine into, through, and out of the body — safety, and immunogenicity (whether or not it induces an immune response) to the previously approved dose.

“Biosimilars are extensively studied, FDA-approved treatments,” said Steve Taylor, president and CEO at the Arthritis Foundation. “There are millions of patients affected by chronic inflammatory conditions that drastically impact their everyday lives. Given the high burden of disease for these conditions, biosimilars are one potential solution for healthcare providers and patients to consider, to ensure patients can take and stay on their medicines to help manage their disease and health outcomes.”

Adalimumab, the active ingredient in Humira and Hyrimoz, blocks the activity of the tumor necrosis factor (TNF), a protein produced by immune cells that’s involved in the inflammatory process that occurs in diseases such as AS. By blocking TNF, adalimumab helps reduce inflammation and relieve the symptoms of AS and other diseases.

The FDA approved a high concentration formulation of a Humira biosimilar, called Hadlima (adalimumab-bwwd), last year.