FDA approves citrate-free, high-concentration form of biosimilar Hyrimoz
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The FDA has approved a citrate-free, high-concentration formulation of the adalimumab biosimilar Hyrimoz, according to a press release from the manufacturer.
The 100 mg/mL formulation of Hyrimoz (adalimumab-adaz, Novartis Sandoz) is expected to launch in the U.S. marketplace on July 1, Sandoz stated.
“As one of the first adalimumab high-concentration formulation biosimilars approved in the U.S., Hyrimoz [high-concentration formulation (HCF)] 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, MBA, president of Sandoz U.S. and head of North America, said in the release.
“Sandoz has more than 2 decades of experience researching, developing and bringing biosimilars to markets across the globe,” she added. “We are excited to continue this leadership by providing patients with another treatment option to help manage their chronic conditions.”
According to the company, the FDA approval was based on a phase 1 pharmacokinetics bridging study that compared the FDA-approved 50 mg/mL dosage to the citrate-free, 100 mg/mL formulation. The study met all of the primary objectives, demonstrating comparable pharmacokinetics as well as similar safety and immunogenicity between the two formulations.
The FDA initially approved Hyrimoz as the third adalimumab (Humira, AbbVie) biosimilar in October 2018. It is currently indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.
Despite the 2018 approval, Hyrimoz has yet to be released in the U.S. market due to legal wrangling over patents between AbbVie, which produces the originator drug, and various biosimilar manufacturers. Following a series of settlements, at least eight FDA-approved adalimumab biosimilars have been cleared for a 2023 release in the United States, with Amgen’s Amjevita (adalimumab-atto) being the first out of the gate on Jan. 31.
Humira, which has long been the highest-grossing drug in the world, topped $20 billion in global revenues in 2021.
According to the company, Sandoz has nearly 120 million days of patient experience with Hyrimoz across 40 countries. When it launches, Hyrimoz HCF will represent the first appearance of a Sandoz biosimilar in the U.S. market for this patient population.
“Biosimilars are extensively studied, FDA-approved treatments,” Steve Taylor, president and chief executive officer of the Arthritis Foundation, said in the release. “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 health care providers and patients to consider, to ensure patients can take and stay on their medicines to help manage their disease and health outcomes.”
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