USA — The FDA has approved Fresenius Kabi’s adalimumab biosimilar Idacio to treat patients suffering from chronic autoimmune diseases such as plaque psoriasis and Crohn’s disease.

It refers to AbbVie’s Humira (adalimumab). Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Fresenius Kabi intends to release the product in the United States in July 2023 as a self-administered prefilled syringe and a self-administered prefilled pen (autoinjector).

The new formulation of adalimumab is a monoclonal antibody designed to bind Tumor Necrosis Factor-alpha (TNFα) and then block the cytokine effects, and it is free of citrate.

The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

Moreover, Humira’s behemoth status makes their introduction in the US particularly interesting.

Since its first launch in 2019, Idacio has been approved and commercialized in more 37 countries around the world.

This second U.S. biopharmaceutical approval serves to broaden and diversify our U.S. portfolio to bring even more value to patients, payers, and healthcare providers, and to reduce the financial pressure on healthcare systems globally,” Michael Schönhofen, Ph.D., Fresenius Kabi’s chief operating officer, said in a press release.

Humira is a widely prescribed drug in the United States, with sales expected to exceed US$17 billion in 2021.

Specialty drug costs, including Humira, account for 50% of drug cost expenditure and are expected to reach US$505 billion by 2023, despite accounting for only 2% of prescriptions. Over the next five years, potential savings from biosimilars could exceed US$100 billion.

This is Fresenius Kabi’s second biosimilar approval in the United States. In September 2022, the FDA approved Fresenius Kabi’s biosimilar Stimufend for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

The product will be available as a prefilled syringe early next year, according to the company. Stimufend is a biosimilar to Neulasta, which is manufactured by Amgen. In addition, the company is working on an on-body injector for Stimufend.

This is the eighth Humira to be approved and made available next year. Amgen’s Amjevita will be the first to hit the market in January.

Organon’s Hadlima, Boehringer Ingelheim’s Cyltezo, Coherus BioSciences’ Yusimry, Viatris’ Hulio, Sandoz’ Hyrimoz, and Pfizer’s Abrilada are among the others set to launch in the second half of the year.

The competitive strengths of the biosimilars that will be available soon vary. Amgen’s Amjevita, for example, will have the advantage of entering the market six months before any other competitor on January 31, 2023. It is only made with the original formula.

Cyltezo, manufactured by Boehringer Ingelheim, is the only biosimilar that has been designated by the FDA as interchangeable with Humira, which means that, unlike other biosimilars, it can be used to fill a prescription for Humira.

 However, unlike Humira, it cannot be self-injected and is only approved for its original formulation.

Hadlima, manufactured by Samsung Bioepis, is the only one to date to be approved with the high-concentration, citrate-free formulation.

However, while an interchangeability study has been conducted, the results will not be available until 2024, implying that it will not be able to obtain interchangeability approval until at least 2025.

Icelandic drugmaker Alvotech, which settled with AbbVie earlier this year and is supposed to enter the market on July 1, 2023, began making its biosimilar after the new concentration was on the market.

As a result, it was able to conduct the testing necessary to apply for biosimilar and interchangeability approval in the United States, as well as in Canada and Europe.

Yet so far, it has received neither approval in the US: The FDA required the company to correct certain issues with its manufacturing plant in Reykjavik in order to comply with its standards.

As it stands, come 2023 the US market will not have a biosimilar interchangeable with AbbVie’s high-concentration, citrate-free Humira.

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