Radar on Specialty Pharmacy

June 10: The FDA approved Cycle Pharmaceuticals Ltd.’s Harliku (nitisinone) for the reduction of urine homogentisic acid in adults with alkaptonuria (AKU), an ultra-rare hereditary disorder also known as black urine disease. It is the first FDA-approved treatment for AKU. The agency first approved the hydroxyphenyl-pyruvate dioxygenase inhibitor as Nityr on July 26, 2017, for a different indication. Recommended dosing of the tablet is 2 mg once daily. The drug is launching in July.

Fresenius Kabi AG’s Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) have launched in the U.S., the manufacturer said on July 1. The launch of the biosimilars of Amgen Inc.’s Prolia (denosumab) and Xgeva (denosumab) follows that of Sandoz’s first-to-market Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz) in June. The FDA approved the receptor activator of nuclear factor-kappa B ligand (RANKL) inhibitors on March 25, 2025. The new agents are approved for all indications of their reference products.

The first biosimilars of Amgen Inc.’s Prolia (denosumab) and Xgeva (denosumab) have launched onto the U.S. market, with more expected to follow soon. On June 2, Sandoz said that it had launched Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz), with an eye on bringing a more cost-effective option to patients of the reference drugs, which have undergone more than 20 price increases since their approval. It remains to be seen whether the manufacturer will choose the private-label route favored by recent biosimilar launches.

Approved on March 5, 2024, the agents also are the only biosimilars of Prolia and Xgeva, respectively, with interchangeable status for all indications of the reference drugs.

During his first administration, President Donald Trump attempted to implement most-favored nation (MFN) pricing but was deterred by legal rulings. Undeterred, he again introduced the idea via an executive order (EO) on May 12. If implemented, the EO could have unforeseen, long-term impacts on the U.S. health care system, say industry experts. But it’s unclear whether implementation of the EO is the ultimate goal, they say.

While the proposal seems to be more extensive than his previous attempts at implementation of the model, it is scarce on details about how the process will go.

While it appears unclear whether the administration is intending for most-favored nation (MFN) pricing to apply to commercial health plans, most stakeholders agree that it would be extremely difficult to do. But if the administration is successful in putting MFN into effect in at least Medicare, private insurers could feel the impact. AIS Health, a division of MMIT, spoke to a handful of industry experts on how MFN pricing, as introduced in a May 12 executive order (EO), could affect the commercial market.

Michael Abrams, managing partner of Numerof & Associates: Lower domestic drug prices would reduce utilization costs for the 50% or so of patients across the country who are on some form of government insurance. And even though it may have no direct authority over reimbursement rates in the commercial insurance space, those prices are public, and they would inevitably become a data point influencing commercial reimbursement.