Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

Tofidence (tocilizumab-bavi – Biogen) intravenous (IV) injection was approved on Sept. 29, 2023, by the U.S. Food and Drug Administration (FDA) as the first biosimilar for the IV form of Genentech’s Actemra®. It is indicated for treating active, moderate to severe cases of rheumatoid arthritis (RA) in adults, and polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA) in patients who are as young as two years old. For adults who have RA, the recommended once-monthly dose is 4mg/kg, which can be increased to 8mg/kg if needed. For children who weigh less than 30kg (66 pounds) the dose for PJIA is 10mg/kg; for SJIA 12mg/kg. For those who weigh more, the pediatric dose is 8mg/kg for either juvenile condition. A boxed warning cautions that using any tocilizumab drug may increase the risk of opportunistic bacterial, fungal, viral, or other infections. Before tocilizumab is started and during treatment with it, patients should be tested for tuberculosis (TB). Launch date and pricing are not yet available for Tofidence. Here is its complete prescribing information.

At a Glance

  • Brand (Generic) Name: Tofidence (tocilizumab-bavi)
  • Manufacturer: Biogen
  • Date Approved: Sept. 29, 2023
  • Indication: to treat adults who have RA and patients aged two years and older who have PJIA or SJIA
  • Dosage Forms Available: single dose 80mg/4mL, 200mg/10mL and 400mg/20mL vials for dilution
  • Launch Date: Being determined
  • Estimated Annual Cost: Not yet announced
  • Tocilizumab blocks interleukin-6 (IL-6) to reduce inflammation.
  • Actemra also has a subcutaneous (SC) dosage form, which does not yet have a biosimilar.
  • Additionally, Tofidence is not approved for indications that Actemra has for cytokine release syndrome (CRS), giant cell arteritis (GCA), and systemic sclerosis-associated interstitial lung disease (SSc-ILD), hospitalized adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or ventilation or for the emergency use authorization (EUA) of COVID-19 in hospitalized pediatric patients (2 years of age or older) who are receiving systemic corticosteroids and require supplemental oxygen or ventilation.
  • In 2022, Actemra’s U.S. sales amounted to $1.2 billion.