Boehringer Ingelheim is Second Company to Provide Private-Label Humira Biosimilar to Evernorth

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Boehringer Ingelheim also received FDA approval for a high-concentration formulation of Cyltezo, its branded Humira biosimilar.

FDA has approved Boehringer Ingelheim’s high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company’s interchangeable biosimilar to Humira (adalimumab), to treat patients with multiple chronic inflammatory diseases.

The high-concentration formulation (100 mg/mL), which is now available as a pre-filled syringe or pre-filled autoinjector, is priced at a 5% discount to Humira under the brand name Cyltezo and at an 81% discount to Humira as the unbranded product Adalimumab-adbm. The low-concentration (50 mg/mL), citrate-free formulation of Cyltezo has been commercially available since July 2023.

Humira is used to treat several immune conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, ulcerative colitis, Crohn’s disease, uveitis, and hidradenitis suppurative. It has a price of $7,299 according to Drugs.com.

Cyltezo’s approval for the high-concentration fomulation is based, in part, on data from clinical trial VOLTAIRE-HCLF, a phase 1 clinical trial comparing the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm.

Boehringer Ingelheim also announced that it will be providing adalimumab-adbm through a private-label agreement with Evernorth Health Services. This makes the second company to be manufacturing a private-label Humira biosimilar to Evernorth. Boehringer Ingelheim will be manufacturing adalimumab-adbm for Quallent Pharmaceuticals, Evernorth’s affiliate private label pharmaceutical distributor.

Under the terms of the agreement, Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent. Boehringer Ingelheim will continue to commercialize the branded Cyltezo (adalimumab-adbm) injection and the nonbranded adalimumab-adbm.

"Our intent is to offer a copay assistance program, which will provide eligible patients access,” said John Caulfield, President of Quallent Pharmaceuticals Health said in a recent news release. “Quallent was established to help pharmacies give their patients safe and affordable medication, and this collaboration will help us deliver on this goal.”

Alvotech also announced this week that it will manufacture its high-concentration interchangeable biosimilar of Humira for Quallent Pharmaceuticals. This is part of the Alvotech’s U.S. commercialization agreement with Teva. The biosimilar will be distributed under Quallent’s private label and will be available in June through Evernorth’s Accredo specialty pharmacy.

Related: Evernorth to Offer Private Label Humira Biosimilar

Last week, Evernorth announced it would be offering a private label Humira biosimilar through agreements with multiple manufacturers. The interchangeable biosimilar will be available in June for $0 out-of-pocket cost for eligible patients of its specialty pharmacy Accredo, Evernorth officials said in a news release.

This study has been updated to include additional information from Boehringer Ingelheim.

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