U.S. Commercialization Agreement with Quallent to Drive Patient Savings with First High-Concentration Citrate-Free Interchangeable Biosimilar to Humira (adalimumab)

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), disclosed today that under the recently announced U.S. strategic partnership agreement, Alvotech will manufacture its high-concentration interchangeable biosimilar to Humira (adalimumab) for Quallent Pharmaceuticals with, in alignment with its U.S. commercialization agreement with Teva. The interchangeable biosimilar will be distributed under Quallent’s private label.

“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.”

“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 U.S. market. With our commercial partners for the U.S., we aim to increase healthcare access and ensure that affordable high-quality biologics are available to patients in need,” said Robert Wessman, Chairman and CEO of Alvotech.

“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,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva. “The strategic partnership between Teva and Alvotech has already yielded two approved critical biosimilars, from a portfolio of nine partnered products. Two partnered biosimilar candidates are coming out of clinical development this year.”

The U.S. Food and Drug Administration (FDA) approved Alvotech’s biosimilar on February 24, 2024, as a high-concentration interchangeable biosimilar to Humira, for the treatment of 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. This is the first high-concentration, citrate-free biosimilar to Humira granted an interchangeability status by the FDA and Alvotech will have interchangeable exclusivity for the 40mg/0.4mL strength. Nearly 88 percent of U.S. prescriptions for adalimumab are for the high-concentration presentations [1].