FDA Approves Actemra Biosimilar Tocilizumab-Anoh
Tocilizumab-anoh is the biosimilar formulation for ACTEMRA, a medication used to treat rheumatoid arthritis, COVID-19, and other diseases.
The FDA approved Celltrion’s tocilizumab-anoh (Avtozma) as a biosimilar formula for the drug Actemra, used to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and COVID-19. Approved for both intravenous (IV) and subcutaneous (SC) use, Avtozma is now the biopharmaceutical company’s fifth immunology biologic and seventh biosimilar approved, according to a release.1
RA is a disease that impacts the joints. | image credit: Zay Win Htai / stock.adobe.com
“Introducing both IV and SC formulations of AVTOZMA provides flexibility and a wider range of treatment options,” said Chief Commercial Officer of Celltrion USA Thomas Nusbickel. “This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and health care providers.”
Key data that led to its approval came from a phase 3 study of patients with moderate-to-severe active RA. Study results detailed the biosimilarity between Avtozma and a reference dose of tocilizumab. With the primary endpoint of the study met, patients experienced a successful change in disease activity scores at week 24. The 1-year study results also showed that Avtozma had comparable efficacy, pharmacokinetic, safety, and immunogenicity when matched with tocilizumab.
“Avtozma will be available in both IV and SC formulations, with the same formulation and dosages as the reference product,” continued authors of the release.1 “The IV infusion is provided as 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) and the SC injection comes in 162 mg/0.9 mL in a single-dose, prefilled syringe or single-dose autoinjector.”
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Both formulations of the drug contain the active ingredient tocilizumab, which is a recombinant humanized monoclonal antibody, and it acts as an interleukin 6 (IL-6) receptor antagonist.1 Over 15 years before its biosimilar approval, tocilizumab was first approved by the FDA as ACTEMRA in January 2010 to treat patients with moderate-to-severe RA who had inadequate responses to tumor-necrosis-factor antagonists.2
At the time of its approval, tocilizumab was the first monoclonal antibody designed to inhibit IL-6 activity, which is produced in the body’s joints similar to those affected by RA. Since its approval in 2010, tocilizumab has benefited patients with RA across several different age groups. Indeed, with AVTOZMA having the same indications as ACTEMRA, the newly approved biosimilar is now available for patients 2 years old and up with active pJIA and sJIA, as well as adults with GCA, RA, and COVID-19.
Avtozma does have a risk of serious infections including active tuberculosis in the presentation of pulmonary disease and a variety of infections such as bacterial, viral, or invasive fungal. Furthermore, Avtozma is reported to cause increased risk of serious infections specifically for patients using concurrent immunodepressants.1
Despite its risks of adverse events, patients with RA now have more options for treating their disease, which impacts around 1.5 million individuals in the US.3 With access to treatment for RA showing some evidence of a link to patients’ socioeconomic status,4 the announcement of a tocilizumab biosimilar provides patients with greater accessibility.
“Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs,” concluded Nusbickel.1
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