SWITZERLAND — Sandoz, a global leader in generic pharmaceuticals and biosimilars, has received approval from the FDA for a citrate-free, high-concentration formulation (HCF) of Hyrimoz, the Humira (adalimumab) biosimilar.
The newly approved biosimilar is designed to treat the same 7 indications covered by the reference product, Humira, at a 100 mg/mL injection.
This follows the FDA’s approval of a low-concentration formulation of Hyrimoz in 2018, both of which will be launched by Sandoz on July 1.
The HCF version of Hyrimoz has the potential to expand access for millions of people who live with inflammatory diseases and enhance the patient experience.
A phase 1 pharmacokinetics (PK) bridging study was submitted to FDA for review for approval, which showed comparable PK, safety, and immunogenicity between the HCF and the FDA-approved 50 mg/mL version of Humira.
Although there are other HCF Humira biosimilars, the citrate-free, HCF of Humira currently has the largest market share due to its ability to reduce the injection volume for patients and minimize pain at the injection site.
Amjevita, the first biosimilar of Humira, was launched in the United States earlier this year, and by the end of the year, at least seven more biosimilars of Humira are expected to launch.
One factor that will differentiate these products is the interchangeability designation. Currently, Cyltezo is the only approved interchangeable biosimilar of Humira.
However, the FDA is reviewing an interchangeability application for Abrilada, which is already approved.
The FDA is also reviewing Alvotech’s biosimilar, AVT02, as an interchangeable biosimilar, with a decision expected by April 13.
According to a report by Goodroot published in January, Humira biosimilars are expected to gain up to 5% market share in 2023, with a maximum of 20% to 25% by 2026.
However, the report suggests that biosimilars may not produce cost savings in the short term.
Humira is the highest-grossing drug of all time, generating US$21 billion in annual global sales in 2021, with patients and their insurers paying over US$80,000 annually for treatment.
As a result, competition in the form of lower cost biosimilars has been eagerly anticipated.
“Though they are finally reaching the market, there are several obstacles to Humira biosimilars lowering healthcare costs,” said Nuwae President Ralph Pisano, in a press release for Goodroot’s white paper.
One of the obstacles is physicians’ reluctance to switch patients with stable disease to a biosimilar.
Additionally, it is expected that AbbVie, the maker of Humira, will increase its rebate to remain competitive in the market and maintain a preferred status on most formularies.
Pisano said that 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.
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