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Organon Expands Portfolio With Biosimilar Tocilizumab-bavi for Arthritis and COVID-19
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Key Takeaways
- Organon acquired U.S. rights for tocilizumab-bavi, a biosimilar to tocilizumab, for treating rheumatoid arthritis and COVID-19.
- Tocilizumab-bavi is available in three vial sizes for intravenous infusion, with Bio-Thera Solutions retaining manufacturing rights.
Tocilizumab-bavi received FDA approval in September 2023 as the first biosimilar to tocilizumab for the treatment of various adult and pediatric arthritis conditions.
Organon announced that it has attained regulatory and commercial rights in the United States from Biogen Inc for tocilizumab-bavi (Tofidence), a biosimilar of tocilizumab (Actemra; Genentech) for intravenous infusion. The biosimilar is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA), giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19, the disease caused by SARS-CoV-2.1
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The regulatory and commercial rights to tocilizumab-bavi include 3 vial sizes for further dilution prior to intravenous infusion: 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL. However, Bio-Thera Solutions, the developer, retains the manufacturing rights for tocilizumab-bavi in the US. Under the agreement, Organon made an upfront payment and will pay tiered royalties and sales milestone payments to Bio-Thera Solutions based on net sales.1
“We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product,” Kevin Ali, chief executive officer of Organon, said in a news release.1
The injection is intended to be used alone or together with other medicine to treat moderate to severe RA among individuals that were previously treated with other medicines that were ineffective. The intravenous infusion should be administered by a trained professional, placed into the vein, and given slowly for 60 minutes.2
Tocilizumab-bavi received FDA approval in September 2023 as the first biosimilar to tocilizumab for the treatment of various adult and pediatric arthritis conditions, including RA, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. Following the approval, the biosimilar was launched in May 2024.3
As an autoimmune disease, RA mistakenly attacks the healthy cells in the immune system, causing painful swelling in the joints. RA primarily targets the joints and can impact multiple joints simultaneously.2 Once RA reaches the moderate stage, individuals can experience a loss of mobility and pain due to joint cartilage and bone damage. Severe RA causes cartilage and bone destruction, allowing the bones to rub together.4
Polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis are also inflammatory joint diseases, causing warmth, swelling, and tenderness. Polyarticular arthritis affects several joints, while systemic arthritis can present with additional symptoms like fever, rash, enlarged lymph nodes, and an enlarged spleen or liver.4
Individuals hospitalized with COVID-19 who received systemic corticosteroids and required supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) could also be treated with tocilizumab-bavi.2
The FDA noted that the approval of tocilizumab-bavi was based on a comprehensive review of scientific evidence that demonstrated its similarity to its reference product, tocilizumab. The review demonstrated that the products had no clinically meaningful differences with highly similar known safety and efficacy profiles. However, the safety and efficacy of tocilizumab-bavi has not been established for other conditions in pediatric patients younger than 2 years of age with polyarticular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis.2 The most common adverse reactions included upper respiratory tract infections, nasopharyngitis, headache, hypertension, and increased alanine transaminase.4
Pharmacists play an essential role in the safe and effective use of tocilizumab-bavi, ensuring appropriate dosing and monitoring adverse effects. It is crucial that pharmacists remain educated on updates in the biosimilar landscape to provide accurate recommendations for patients.
