Abbvie Inc.’s blockbuster drug Humira is getting a new challenger that could give all the other adalimumab biosimilars a run for their money – depending on pricing and formulary coverage, of course. After delays caused by manufacturing issues, the FDA has approved Simlandi, a Humira biosimilar and interchangeable partnered by Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech Holdings SA, a pure-play biosimilars company based in Iceland. What sets Simlandi apart from all the other Humira biosimilars that launched last year is that it’s the first citrate-free, high-concentration interchangeable in the U.S., meaning it can automatically be substituted at the pharmacy when the high-concentration Humira is prescribed, provided the patient’s insurance will cover it. With the high-concentration formulation accounting for nearly 88% of Humira prescriptions, that could be a big advantage for Simlandi.

GSK’s oral antibiotic hits endpoints in gonorrhea study

With a regulatory filing expected later this year for gepotidacin based on positive data in uncomplicated urinary tract infections, GSK plc reported that the potentially first-in-class oral antibiotic hit its endpoints in a phase III trial in gonorrhea, the sexually transmitted disease facing a rise in incidence rate and increased antibiotic resistance. The London-based pharma is expected to unveil detailed results at an upcoming scientific meeting, but top-line data from the pivotal Eagle-1 trial showed gepotidacin, administered in oral doses of 3,000 mg, was noninferior to the current standard antibiotic regimen for gonorrhea, an intramuscular injection of ceftriaxone and oral administration of azithromycin. The primary endpoint measured microbiological response at the test-of-cure visit, three to seven days after patients received treatment.

BIO CEO 2024: This downturn will end … eventually

Companies and investors, well aware of the natural up and down fluctuations of the market, keep expecting the current downturn to end. They’ve been expecting it to begin an upturn for the past two years. During a Monday session on venture capital trends at the BIO CEO & Investor Conference in New York, investors said the tough times might well extend further into 2024 than they would like. Both Jonathan Norris, managing director of HSBC Innovation, said his expectations had been confounded in the past two years and that the current pace of investment is similar to the second half of 2022. He said that while he sees investors continuing to put smaller deals together than during more financially healthy times, biopharma will see less of a decrease in capitalization than the rest of the health care sector.

Aribio gains UK approval to start phase III trial of Alzheimer’s drug

Korean neurodegenerative disease-focused Aribio Co. Ltd. gained the U.K.’s regulatory clearance to start the phase III Polaris-AD trial on AR-1001 (mirodenafil), an investigative therapy for early Alzheimer’s disease (AD). The U.K.’s Ministry of Health and Regulatory Affairs gave notice of acceptance to Seoul, South Korea- and San Diego-based Aribio for the clinical study on Feb. 21 after “confirming a favorable ethical opinion,” Aribio said. AR-1001 is an oral phosphodiesterase-5 inhibitor under development to treat early AD. 

Australian incubator developing drugs, devices for dementia

With the number of people with dementia in Australia expected to nearly double by 2054, the federal government is funding a new AU$50 million (US$32.76 million) biomedical and med-tech incubator program to develop new therapies, medical devices and digital health technologies to address dementia and cognitive decline. To be managed by Brandon Biocatalyst’s Cureator program and digital health incubator Andhealth, the program follows an earlier $50 million incubator program announced in March 2023 under which funds are deployed like an investment but are nondilutive and don’t require any equity transfer, Brandon Biocatalyst CEO Chris Nave told BioWorld in an earlier interview.

SK Bio wins WHO prequalification for typhoid conjugate vaccine

SK Bioscience Co. Ltd. of Seongnam-si, South Korea, gained the World Health Organization’s (WHO) prequalification certification for typhoid conjugate vaccine, SKYTyphoid (NBP-618), on Feb. 23. SKYTyphoid conjugates a polysaccharide of typhoid bacteria, which serves as an antigen, to a diphtheria toxin protein called diphtheria toxoid that acts as a carrier. The stamp of approval adds SKYyphoid to WHO’s list of prequalified vaccines, paving the way for public procurement by United Nations organizations. SK Bioscience co-developed SKYTyphoid with the International Vaccine Institute, along with support from the Bill & Melinda Gates Foundation.

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Also in the news

Baseimmune, Bavarian Nordic, Biodexa, Biogen, Brainstorm Cell, Bristol Myers Squibb, Celltrion, Cinphloro, Clearmind Medicine, Coeptis, Cogent, Diakonos Oncology, Disc Medicine, Eisai, Gamida Cell, Jiangsu Nhwa, Johnson & Johnson, Legend, Lixte, Maia, Max, Melinta, Merck, Metaba, Neuraptive, NGM, Nova Mentis, Ocugen, Pfizer, Rayzebio, Sanofi, Seres, Teva, Travere, Venatorx, Vertex, Voyager