Eye on Pharma: EU Approves High-Concentration Adalimumab Biosimilar; FDA Accepts BLA for HLX02

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The European Union gained another high-concentration adalimumab biosimilar with the approval of Sandoz’ Hyrimoz HCF and the FDA accepted a biologics license application for a trastuzumab biosimilar (HLX02).

The European Union gained another high-concentration adalimumab biosimilar with the approval of Sandoz’ Hyrimoz HCF and the FDA accepted a biologics license application for Accord BioPharma and Shanghai Henlius Biotech’s trastuzumab biosimilar (HLX02).

European Approval of Hyrimoz HCF

The European Commission has granted marketing authorization to Sandoz’ citrate-free, high-concentration (HCF) version of its adalimumab biosimilar, Hyrimoz. The HCF formulation allows for patients to receive treatment with a reduced injection volume (100 mg/mL vs 50 mg/mL) and less injection site pain compared with the original, low-concentration version.

Hyrimoz HCF will be used to treat patients with rheumatoid arthritis, Crohn disease, ulcerative colitis, plaque psoriasis, uveitis, and hidradenitis suppurativa. The biosimilar references Humira, one of the most profitable drugs in the world. The news comes after the FDA approved Hyrimoz HCF (adalimumab-adaz) in March 2023.

“Living with a chronic disease can take a significant toll on a patient’s quality of life. Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, head of region Europe at Sandoz, in a statement.

The approval was based on a phase 1 pharmacokinetics (PK) bridging study comparing the low-concentration version of the biosimilar vs Hyrimoz HCF. The study met all the primary endpoints and demonstrated comparable PK, safety, and immunogenicity profiles between the 2 formulations.

“With eight marketed biosimilars Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe with more than two decades of experience. Today’s approval brings Sandoz one step closer to providing European patients with chronic conditions an additional treatment option that offers increased convenience and a reduction in injection volume,” Guntern explained.

FDA Accepts BLA for HLX02

Accord BioPharma, the US division of Intas Pharmaceuticals, announced that the FDA has accepted its BLA for HLX02, a proposed trastuzumab biosimilar, for the treatment of human epidermal growth factor 2 (HER2)-overexpressing breast and gastric cancer.

The product references Herceptin (trastuzumab) and if approved, it will become the sixth trastuzumab biosimilar to receive regulatory approval in the United States.

“We're thrilled to announce this regulatory milestone as we work to provide patients increased options and access for treatment of serious conditions in oncology, immunology, and critical care,” commented Chrys Kokino, president of US BioPharma at Accord BioPharma.

HLX02 was originally developed by Accord BioPharma’s business partner Shanghai Henlius Biotech. As part of their agreement, in 2021, Henlius gave Accord the exclusive rights to develop and commercialize HLX02 in the United States and Canada.

The biosimilar has been approved in over 30 countries, including those in the European Union (July 2020) as well as China (August 2020) for the same indications as the originator product. The BLA submission included data from nonclinical studies; a phase 1 PK similarity study; and a global, multicentric phase 3 safety, efficacy, and immunogenicity study in relevant patient populations. The phase 3 analysis demonstrated biosimilarity between the biosimilar and the reference product.

Kokino added, “Biosimilars are key to making healthcare more affordable and accessible. We're working to develop the deepest portfolio of biosimilars to enhance the patient experience and improve the cost of care across the continuum.”

Accord BioPharma also has 2 other biosimilars that have been approved in the United States, and the company said that it plans to introduce more in the next 5 years.

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