Update on Biosimilar Insulins: A US Perspective
| العنوان: | Update on Biosimilar Insulins: A US Perspective |
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| المؤلفون: | Janet B. McGill, Ritika Puri, Rong M. Zhang |
| المصدر: | BioDrugs |
| بيانات النشر: | Springer Science and Business Media LLC, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | medicine.medical_specialty, medicine.medical_treatment, Insulins, Insulin Glargine, Article, 03 medical and health sciences, 0302 clinical medicine, Biosimilar Pharmaceuticals, medicine, Humans, Hypoglycemic Agents, Insulin, Insulin lispro, Pharmacology (medical), Intensive care medicine, Drug Approval, 030203 arthritis & rheumatology, Pharmacology, Insulin glargine, Biosimilar, General Medicine, United States, Reference product, 030220 oncology & carcinogenesis, Business, Insulin products, Healthcare providers, Biotechnology, medicine.drug |
| الوصف: | The development of biosimilar insulin products has slowly evolved with only two follow-on biologics currently available to patients in the US. Both Basaglar® (insulin glargine) and Admelog® (insulin lispro) have undergone extensive testing, including clinical trials of up to six months duration, and have gained significant use by patients in the US. Despite the availability of these follow-on products, the price of insulin has remained stubbornly high. New regulatory guidance under the Biologics Price Competition and Innovations Act which came into effect March, 2020 introduced an abbreviated pathway for the approval of biosimilar insulins and introduced the option to apply for interchangeability of the biosimilar insulin with the reference product. This abbreviated clinical testing may open the doors for numerous follow-on insulin products, with unknown supply-chain and fiscal ramifications. This review will highlight the development process of biosimilar insulin in the US and the recent regulatory changes which can aide this process. We will also discuss challenges for prescribers and patients who are navigating this ever-changing landscape. These new regulations for biosimilar insulins will have ramifications for patients, health-care providers and third-party payers, though the direction and scope of these changes is unclear. |
| تدمد: | 1179-190X 1173-8804 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cfc401bfc64721a3bca71a52f93dd1b1Test https://doi.org/10.1007/s40259-020-00431-0Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....cfc401bfc64721a3bca71a52f93dd1b1 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1179190X 11738804 |
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