Hyrimoz, a High-Concentration Humira Biosimilar, Approved by FDA

The FDA has approved a citrate-free, high-concentration formulation (HCF) of Hyrimoz, the Humira (adalimumab) biosimilar from Sandoz.

The biosimilar is approved as a 100 mg/mL injection to treat the 7 indications covered by the reference product, Humira: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.

FDA had already approved a low-concentration formulation of Hyrimoz back in 2018. Sandoz will launch both versions on July 1.

“As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz 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, president, Sandoz Inc., head of North America, said in a statement.

A phase 1 pharmacokinetics (PK) bridging study comparing the FDA-approved 50 mg/mL version of Humira with the HCF was submitted to FDA for review for approval. The study demonstrated comparable PK, as well as similar safety and immunogenicity between the 2 versions.

There is a HCF Humira biosimilar, Hadlima, from Organon and Samsung Bioepis that was already approved in August 2022. There are applications for HCF versions from Alvotech and Celltrion Healthcare that are both currently being reviewed by the FDA.

The citrate-free, HCF of Humira currently has the most market share. The HCF means patients have to inject a smaller volume of the drug, while the citrate-free formulation causes less pain at the injection site.

At the beginning of the year, Amjevita, the first Humira biosimilar launched in the United States. By the end of the year, at least another seven Humira biosimilars, will launch. One differentiation among the products will be the interchangeability designation. Right now, Cyltezo is the only approved interchangeable Humira biosimilar; however, the FDA is reviewing an interchangeability application for Abrilada, which is already approved. In addition, the FDA is reviewing AVT02, Alvotech’s biosimilar, as an interchangeable biosimilar. A decision on AVT02 is expected by April 13.

In January, Goodroot published a report on the potential savings of Humira biosimilars coming to the market. In 2023, Humira biosimilars are expected to gain up to 5% market share, reaching a maximum of 20% to 25% of market shared by 2026. Unfortunately, Humira biosimilars arenot expected to produce cost savings in the short term, according to the white paper.

Humira is the highest grossing drug of all time, bringing in $21 billion in annual global sales in 2021, with the cost to patients and their insurers topping $80,000 annually. As such, competition in the form of lower cost biosimilars has been hotly anticipated.

“Though they are finally reaching the market, there are several obstacles to Humira biosimilars lowering healthcare costs,” Nuwae President Ralph Pisano, RPh, said in a press release for Goodroot’s white paper. Physicians may be reluctant to switch patients who have stable disease to a biosimilar. In addition, it is expected that AbbVie, the maker of Humira, will increase its rebate to remain competitive in the market and keep a preferred status on most formularies.

“By increasing their rebates just 10 percent, AbbVie can match the net cost of biosimilar manufacturers, who also have to pay AbbVie royalties that effectively create a floor to how far they can lower prices,” Pisano said.