A blockbuster Amgen antibody that treats bone circumstances is ready to face its first biosimilar competitors. The FDA on Tuesday accepted two Sandoz medication as interchangeable with and accepted for all makes use of of the Amgen merchandise.
The Amgen antibody, denosumab, is marketed as Prolia for the therapy of osteoporosis. A distinct dose of the antibody is marketed as Xgeva for stopping bone issues in a number of myeloma sufferers in addition to these whose stable tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication shall be marketed beneath the identify Jubbonti. For most cancers, the Sandoz product shall be referred to as Wyost.
The Amgen and Sandoz medication work by binding to a protein referred to as receptor activator of nuclear issue kappa beta ligand, or RANKL. Doing so prevents bone cells referred to as osteoclasts from breaking down bone. This method is meant to end in larger bone mass and energy. The FDA mentioned approval of the Sandoz antibody makes it the primary interchangeable biosimilar for a RANKL inhibitor.
The regulatory resolution for the Sandoz merchandise is predicated on comparative scientific information confirming that Jubbonti and Wyost, every administered as a single subcutaneous injection in wholesome adults, achieved related publicity within the physique because the Amgen medication. A further research in postmenopausal girls with osteoporosis confirmed related efficacy, security, and immune response.
On measures of security, the FDA mentioned the facet impact and adversarial occasions noticed in scientific trials of the Sandoz medication are in step with these of the Amgen merchandise. Prolia’s label sports activities a brand new black field warning that flags the danger of hypocalcemia, or low ranges of calcium within the blood. The label for Sandoz’s Jubbonti additionally carries a warning for this danger. As well as, Jubbonti’s approval comes with a Danger Analysis and Mitigation Technique (REMS), a program that informs sufferers and prescribers concerning the drug’s dangers. That’s in step with Prolia, whose approval additionally got here with a REMS.
Prolia generated $4 billion in income final yr, a 12% enhance over gross sales in 2022, in keeping with Amgen’s annual report. Xgeva’s 2023 income was $2.1 billion, a 5% year-over-year enhance. Like most biosimilar and generic medication, regulatory approval of the Sandoz medication doesn’t sign their rapid availability. Makers of branded merchandise usually flip to patent litigation to maintain their competitors off the market for so long as doable. Amgen sued Sandoz final yr. In a assertion, Sandoz mentioned given the continued patent litigation across the merchandise, it won’t touch upon their launch timing or different launch particulars.
Sandoz was the longtime generics and biosimilars division of Novartis. Like lots of its large pharma friends lately, Novartis evaluated whether or not to spin off its generics and biosimilars enterprise to give attention to the R&D of progressive medicines that convey larger revenue margins. Final fall, Sandoz emerged from Novartis as a standalone publicly traded firm.
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