US FDA Approves Subcutaneous Opdivo, Extending Key BMS Franchise Into 2030s

Injection Cleared 10 Years After I.V. Product

With loss of exclusivity for Opdivo looming in 2028, Opdivo Qvantig will help BMS retain at least some of the revenue for its brand-name blockbuster after biosimilars for the I.V. version hit in 2029.

Opdivo Qvantig is crucial to Bristol's post-Opdivo loss of exclusivity revenue (Shutterstock)

Bristol Myers Squibb’s Opdivo Qvantig, the new subcutaneous version of its PD-1 inhibitor Opdivo (nivolumab), will be available starting in early January with a list price that is at parity with the original I.V. version of Opdivo, BMS chief commercialization officer Adam Lenkowsky told Scrip.

Key Takeaways
  • The US FDA approved Bristol’s subcutaneous version of its PD-1 inhibitor Opdivo, which will be available in early January and priced at parity with the original I.V. formulation.
  • BMS expects Opdivo Qvantig to take about 30%-40% of Opdivo’s business, protecting some of the blockbuster’s revenue after loss of exclusivity for the I.V. product in 2028

The FDA approved Opdivo Qvantig (nivolumab and hyaluronidase) on 27 December for all of the cancer indications included in the Opdivo label when the anti-PD-1 antibody is not combined with Bristol’s CTLA-4 inhibitor Yervoy (ipilimumab),

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