Ustekinumab

Sandoz has partnered with Samsung Bioepis to broaden patient access to high-quality biosimilar medicines worldwide. The agreement allows the companies to work together on up to five biosimilar assets. The first will be a vedolizumab biosimilar, which is in early-stage development. Entyvio (vedolizumab), the reference medicine, is used to treat adults with Crohn’s disease, ulcerative colitis or pouchitis. Sandoz plans to capture a significant share of the projected global biosimilar loss-of-exclusivity market opportunity, which is currently set to grow to an estimated $320bn by 2036, with this partnership potentially expanding the company’s pipeline by up to 32 assets. Richard Saynor, CEO of Sandoz, said: “This partnership underscores our unwavering commitment to expanding access to affordable, high-quality medicines for patients worldwide. “It is another important step toward capitalising on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis.” Under the agreement, Samsung will be responsible for development, regulatory submissions and manufacturing. Sandoz will have exclusive rights to commercialise globally, except in China, Hong Kong, Taiwan, Macau and the Republic of Korea. Financial details of the agreement were not disclosed. Previously, the two companies partnered on Pyzchiva (ustekinumab) and signed an agreement for the commercialisation of Epysqli, for the Middle East and Africa regions, in September 2023 and December 2025 respectively.

FDA clears high-dose Spinraza on second go-roundBoost of $500M for J&J autoimmune drugBMS's Camzyos readout in teens with obstructive HCMBoehringer licenses stroke antibody therapy from EmfretFDA clears high-dose Spinraza on second go-roundThe FDA on Monday approved a high-dose formulation of Spinraza (nusinersen) to treat spinal muscular atrophy (SMA), a win for Biogen after the US regulator had earlier rejected an application for the antisense oligonucleotide (ASO). The September complete response letter did not flag any issues with the supporting efficacy and safety data, but the FDA had requested a technical information update be included in the chemistry, manufacturing and controls (CMC) portion of the drug's application.Biogen said the high-dose regimen — which involves two 50-mg loading doses given two weeks apart, followed by 28-mg maintenance doses every four months — will be available in the US "in the coming weeks." The approval was based on findings from the Phase II/III DEVOTE study in treatment-naïve, symptomatic infants with SMA, in which high-dose Spinraza met its primary endpoint of significantly improving motor function compared to untreated matched controls.With increasing competition from Roche's oral small molecule Evrysdi (risdiplam) in the SMA space, Biogen has been hoping the new Spinraza formulation will refresh interest in the ASO. While its intrathecal delivery mechanism puts it at a dosing disadvantage against oral Evrysdi, Biogen President and CEO Christopher Viehbacher previously emphasised that when it comes to SMA treatments, "It's efficacy that matters, and that's really the story of Spinraza. The high dose, I think, will be important because you can get to the therapeutic levels of drug that you need much faster" (see – Spotlight On: How will newcomers reshape the SMA market?).-Elizabeth EatonBoost of $500M for J&J autoimmune drugJohnson & Johnson and Royalty Pharma have launched a $500-million collaboration aimed at advancing JNJ-4804, a co-antibody therapy that blocks the complementary IL-23 and TNF pathways. The joint funding agreement covers 2026 and 2027.JNJ-4804 is currently in Phase II for ulcerative colitis, Crohn's disease and psoriatic arthritis, according to J&J's website. A few years ago, as the company prepared for Stelara (ustekinumab) generics to hit the market, it highlighted JNJ-4804 as one of over a dozen assets that could potentially generate between $1 billion and $5 billion in peak sales."Royalty Pharma has a strong track record of investing in immunology, beginning with early disease-modifying biologics including TNF inhibitors," noted Royalty CEO Pablo Legorreta in a  release Monday. "We believe JNJ-4804 holds substantial promise for patients with chronic immune-mediated diseases."-Anna BratulicBMS's Camzyos readout in teens with obstructive HCMAfter top-lining upbeat results in January, Bristol Myers Squibb fleshed out detailed late-stage data for Camzyos (mavacamten) in adolescents with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), with the aim of seeking a broader label for the cardiac myosin inhibitor (CMI) in this age group. Findings from the Phase III SCOUT-HCM trial — presented at the American College of Cardiology (ACC) meeting — showed that at week 28, Camzyos delivered a significant and clinically meaningful reduction from baseline in Valsalva left ventricular outflow tract (LVOT) gradient versus placebo, with a least-squares mean difference (LS MD) of -48.0 mmHg. "The SCOUT-HCM results underscore the potential for Camzyos to become the first CMI for adolescents," said Cristian Massacesi, chief medical officer at BMS. "With these meaningful safety and efficacy data, we are excited about the potential to provide a paradigm-changing treatment."Camzyos was first approved by the FDA in 2022 to treat oHCM in adults, and secured a revised label last year that cut down certain monitoring requirements. -Pavan KamatBoehringer licenses stroke antibody therapy from EmfretBoehringer Ingelheim on Monday licensed a preclinical antibody-based asset from Emfret Analytics in development for acute ischemic stroke. While the partners didn't disclose specific details of the deal, Emfret will receive an upfront payment and is eligible for development, regulatory and commercial milestones, plus tiered royalties.The candidate targets the platelet collagen/fibrin receptor glycoprotein VI (GPVI) and is designed to inhibit the biological pathway — which is a driver of harmful thrombo-inflammatory responses in acute ischemic stroke — whilst maintaining normal hemostasis. The antibody programme, intended to be given on top of standard-of-care reperfusion therapies, has shown strong protection from infarct growth in preclinical models."By addressing a central thrombo-inflammatory target, this collaboration explores a novel complementary therapeutic approach with the potential to further improve outcomes when added to established therapies," said Bernhard Nieswandt, Emfret's cofounder and chief scientist.-Elizabeth Eaton