Teva and Alvotech Further Strengthen Their Relationship, Reach Biosimilar Commercialization Deal

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Per the US strategic partnership agreement, the adalimumab high-concentration interchangeable biosimilar will be distributed under the Quallent Pharmaceuticals private label.

Image Credit: Adobe Stock Images/Ahmad.com

Image Credit: Adobe Stock Images/Ahmad.com

Teva Pharmaceuticals and Alvotech, a biotech company that specializes in the development and manufacture of biosimilars, have reached a US strategic partnership agreement.1 Per the deal, Alvotech is set to produce its high-concentration, interchangeable biosimilar to Humira—also known as adalimumab—for Quallent Pharmaceuticals, a private label pharma distributor. In other words, the biosimilar will be distributed under the company’s private label. Teva also reported that this is the first high-concentration, citrate-free biosimilar to Humira.

“We are pleased to be working with Alvotech to bring adalimumab-ryvk to more patients. Our intent is to offer a copay assistance program, which will provide eligible patients access,” said John Caufield, president of Quallent Pharmaceuticals Health, LLC. “Quallent was established to help pharmacies give their patients safe and affordable medication, and this collaboration will help us deliver on this goal.”

In a landscape that includes more than 100 biosimilars in development across 22 molecules2 that not only target conditions currently addressed by biosimilars, such as immune disorders, diabetes, and cancer, Alvotech’s biosimilar has reportedly garnered quite a bit of attention from payors in the US healthcare market.

“Being able to obtain interchangeable exclusivity for the high-concentration formulation which dominates the adalimumab market, has generated significant payor interest for this unique product in the US market. With our commercial partners for the US, we aim to increase healthcare access and ensure that affordable high-quality biologics are available to patients in need,” commented Robert Wessman, Alvotech’s chairman and CEO.

On Feb. 24, 2024, Alvotech became the latest adalimumab biosimilar to be approved and is used to treat adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. and the 11th overall to be granted an interchangeable designation.3 Alvotech will have interchangeable exclusivity for the 40mg/0.4mL dosage.

“At Teva, we continue to be focused on creating cost savings across the healthcare system and providing affordable options, like the high-concentration interchangeable adalimumab, for patients who need them,” noted Thomas Rainey, SVP, US Market Access at Teva. “The strategic partnership between Teva and Alvotech has already yielded two approved critical biosimilars, from a portfolio of seven partnered products. Two partnered biosimilar candidates are coming out of clinical development this year.”

The collaboration between Alvotech and Teva actually dates back to August 2020, when the parties entered into a strategic partnership for the exclusive commercialization of five of Alvotech’s biosimilar product candidates. Then, in August 2023 the companies decided to extend the partnership to now feature two more biosimilars, along with two new presentations of previously partnered products. The duties are divided as so: Alvotech is responsible for the development and manufacturing, while Teva handles the US commercialization aspect.

References

1. U.S. Commercialization Agreement with Quallent to Drive Patient Savings with First High-Concentration Citrate-Free Interchangeable Biosimilar to Humira (adalimumab). Teva Pharmaceuticals. April 30, 2024. Accessed May 3, 2024. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/U.S.-Commercialization-Agreement-with-Quallent-to-Drive-Patient-Savings-with-First-High-Concentration-Citrate-Free-Interchangeable-Biosimilar-to-Humira-adalimumab/default.aspx

2. Gregory F. Kenco grows its next-generation material handling equipment capabilities with new offering, Automation Guidance. Pharmaceutical Commerce. March 15, 2024. Accessed May 3, 2024. https://www.pharmaceuticalcommerce.com/view/getting-the-lay-of-the-land-after-a-banner-year-for-biosimilars

3. Stewart J. What biosimilars have been approved in the United States? Drugs.com. May 1, 2024. Accessed May 3, 2024. https://www.drugs.com/medical-answers/many-biosimilars-approved-united-states-3463281/

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