Organon Expands Biosimilar Portfolio With Tofidence Acquisition

Organon, a global healthcare company with expertise in biosimilars, has acquired the U.S. regulatory and commercial rights for Tofidence (tocilizumab-bavi) from Biogen Inc.

Tofidence is a biosimilar to Actemra, an intravenous treatment used for various inflammatory conditions.

Originally approved by the FDA in September 2023, Tofidence became the first tocilizumab biosimilar available in the U.S. market, launching in May 2024.

It's indicated for treating moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.

Tofidence vial.

An interleukin-6 (IL-6) receptor antagonist that suppresses the immune system by targeting specific inflammatory proteins, Tofidence was initially developed by Bio-Thera Solutions Ltd., with Biogen securing its approval and launch before transferring U.S. rights to Organon.

Organon, an independent global healthcare company focused on improving women’s health, includes more than 70 therapies spanning women’s health, biosimilars and other drug areas within its portfolio.

“Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio,” said Kevin Ali, Organon’s chief executive officer, in a press release. “We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.”

Under this agreement, Organon now holds the U.S. regulatory and commercial rights for Tofidence, which is available in three vial sizes: 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, for dilution before intravenous infusion.

Bio-Thera Solutions Ltd. will retain manufacturing rights for the U.S. market.

The acquisition includes an upfront payment to Biogen, with Organon assuming obligations for tiered royalty payments and sales milestone payments owed by Biogen to Bio-Thera.

When asked why Biogen decided to sell the rights to the drug, a spokesperson shared with Managed Healthcare Executive that, "This divestment reflects our previously announced decision to optimize our biosimilars business and focus on innovative medicines and key growth drivers in the U.S., including the ongoing launches of Leqembi, Skyclarys, and Zurzuvae.

We believe Organon’s expertise in biosimilars commercialization will help Tofidence reach its full potential."

Meanwhile, competition in the tocilizumab biosimilar market continues to grow.

In February 2025, the FDA approved Celltrion’s Avtozma (tocilizumab-anoh), another biosimilar to Actemra.

The second biosimilar to Actemra is Fresenius Kabi’s Tyenne (tocilizumab-aazg), approved in March 2024.

Common side effects associated with tocilizumab products include upper respiratory tract infections, headaches, hypertension, elevated liver enzymes, and injection site reactions.

Pricing for Tofidence varies by vial size.

According to Drugs.com, the cost is approximately $473 for an 80 mg/4 mL vial, $1,168 for a 200 mg/10 mL vial and $2,327 for a 400 mg/20 mL vial, though prices may differ by pharmacy.

After becoming commercially available in the U.S. in the second quarter of 2024, Tofidence generated $1.1 million in U.S. revenue for Biogen. In the fourth quarter of 2024, Biogen reported total revenue of $2.5 billion.

Over the years, biosimilars have contributed significantly to healthcare cost savings.

According to a September 2024 report from the Association for Accessible Medicines, biosimilars have generated $36 billion in savings since 2015. In 2023 alone, they accounted for $12.4 billion in savings.

A study published in JAMA Health Forum found that biosimilar prices are typically 15% to 35% lower than their brand-name counterparts.

These price reductions can also prompt reference biologic manufacturers to lower prices or offer discounts.

Overall, biosimilars are projected to save the U.S. healthcare system between $38 billion and $124 billion from 2021 to 2025.

Organon was contacted on financial details of the acquisition and of Tofidence's cost looking forward.