Even though the EU had approved more than a dozen biosimilars by 2012, the follow-on biologics were still in their embryonic stage around the world when BioWorld published The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies in early 2013. Now, nearly a decade later, the global biosimilar landscape has matured with many more biosimilars approved across the globe, but the uptake, and thus the savings, is not what some policy makers and people in industry had hoped for or expected.
A review of Australia’s National Medicines Policy was begun in August 2021 but was paused until after the federal election in May to allow stakeholders more time to provide feedback.
Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biolab Sciences, Carl Zeiss Meditec, CTL Amedica, Icecure Medical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Everest, GSK, HDT, Innovent, Nanoscope, Novelmed, Pfizer, Scpharmaceuticals, Supernus.
The Medicare coverage with evidence development (CED) program has served a vital function for coverage of medical technology for a number of years, but staff at CMS apparently see room for improvement.
In its case to a U.S. FDA advisory committee, the Center for Drug Evaluation and Research makes no bones about its dislike of Makena, (17-hydroxyprogesterone caproate), a drug for preventing miscarriages. It simply doesn’t work, the group maintains.
Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua.
Long considered a make-or-break market for novel drugs and biologics and a success story for generics, the U.S. has been more challenging for biosimilars than many experts initially expected. U.S. biosimilar “uptake has been good, but not great,” Steven Lucio, senior principal for pharmacy solutions at Vizient Inc., told BioWorld. That could change next year when at least seven biosimilars referencing Abbvie Inc.’s immunosuppressive drug, Humira (adalimumab), are expected to launch in the U.S.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Limacorporate.
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