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Medicare Negotiated Drugs Can Face Immediate Generic, Biosimilar Substitution, CMS Proposal Confirms
Stelara, Xarelto, Januvia and Farxiga, which are expected to have biosimilar or generic competition before the end of 2026, could be the first negotiated drugs subject to the policy.
While Amneal cannot wait to jump into unexplored biologics space, it wants to channel its GLP-1 power into the Metsera partnership and service big pharma, and less so on its own generics.
At the J.P. Morgan Healthcare Conference in San Francisco, Sandoz CEO Richard Saynor commented on the “offensively” low pricing for antibiotics in the US – “less than a packet of M&Ms” – while also revealing that the firm has struck a deal with a US PBM for its Samsung Bioepis-partnered Pyzchiva ustekinumab biosimilar to Stelara.
NutriFusion adds development, innovation head; Dymatize adds tennis pro, Olympic medalist Tommy Paul to Squad; Icy Hot sponsors Unrivaled women’s hoops league; WNBA’s Stevens, Evans invest in, promote Mela Vitamins.
“We have made significant strides in finding new ways to return money to consumers, but a fix to our 13(b) authority is badly needed,” says Sam Levine.
Chairman-designee Andrew Ferguson likely will continue the commission’s investigation of PBMs during the next administration.
Adding to five new clinical trials launched in 2024, Xentria is doubling down on its ambitions in the biosimilars arena with up to six further studies in the coming year.
As Bob Bradway addressed the J.P. Morgan Healthcare Conference in San Francisco, the Amgen chief executive discussed the firm’s biosimilars business – including an ocrelizumab rival to Ocrevus that has just been added to its pipeline. Meanwhile, the CEO also outlined his expectations for imminent biosimilar competition to Amgen’s Prolia and Xgeva denosumab brands.
Supplement and food product firms have until January 2027 and oral drug product firms have until a year later to stop using Red No. 3, FDA decides in approving 2022 petition filed by public health advocacy groups.
The UK market has become tougher for smaller innovators, says Andy Mears, CEO of Deltex Medical, which plans to launch a new iteration of its minimally invasive ultrasound-based technology, the oesophageal Doppler monitor. He explained how market access challenges have steepened.