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Daniel M. Geynisman Guillermo De Velasco K. Lea Sewell Ira Jacobs 《Postgraduate medicine》2017,129(4):460-470
Physicians in training are expected to be aware of the newest developments in patient care. Biologic therapies have changed treatment of many diseases by specifically targeting key disease mediators, but patient access to these therapies can be limited. As patents for the first biologic therapies are expiring, the development and approval of products known as biosimilars is rapidly gaining momentum. A biosimilar is a biologic product that is highly similar to a reference product (a licensed biologic product), notwithstanding minor differences in clinically inactive components. Biosimilars undergo a thorough evaluation compared with the licensed biologic and need to demonstrate comparable clinical pharmacokinetics, efficacy, and safety including immunogenicity. Understanding the processes for new drug approvals, the rigorous evaluation of biosimilars, and considerations about their selection and use can help recently trained physicians to make informed treatment decisions and improve patient outcomes. 相似文献
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Ömür Kayıkçı Emre Tekgündüz Ali Hakan Kaya Hakan Göker Alma Aslan Dicle İskender Sinem Namdaroglu Aysegul Tetik Şerife Koçubaba Fevzi Altuntaş 《Transfusion and apheresis science》2017,56(6):832-835
Biosimilar filgrastim (Leucostim®) was shown to be similar in terms of efficacy and safety in hematopoietic progenitor cell mobilization (HPCM) compared to originator filgrastim (Neupogen®) and lenograstim (Granocyte®) in healthy donors and chemomobilization settings. Here we report our retrospective experience with Leucostim® (n: 43) compared to Neupogen® (n: 71) and Granocyte® (n: 32) in steady-state mobilization of patients presenting with Hodgkin lymphoma, non-Hodgkin lymphoma and multiple myeloma. The median age of patients on Leucostim® (56) arm was significantly higher compared to patients who received Neupogen® (50) and Granocyte® (49) (p: 0.039). Patients who underwent HPCM with Leucostim® received less chemotherapy lines (p: 0.026) and courses (p: 0.046) compared to others. Otherwise the study cohort was homogenous in terms of gender, primary diagnosis and various risk factors for mobilization failure. Mobilization failure was defined as failure to achieve a minimum threshold (10/μL) for peripheral blood CD34+ cell concentration to initiate leukapheresis or 0.5 × 106/kg, 0.8 × 106/kg and 2 × 106/kg CD34+ cells in first, second and fourth days of apheresis, respectively. The study groups were similar in terms of median number of CD34+ progenitor cell yield ( × 106/kg) (Neupogen®: 6.18, Granocyte®: 6.2 and Leucostim®: 6.2) (p: 0.959) and median number of leukapheresis sessions (p: 0.615). The treatment arms were also similar in terms of mobilization failure (Neupogen® 11.3% ? Granocyte® 21.9% ? Leucostim® 16.3%; p: 0.366). No patient experienced any severe adverse effect during HPCM. Leucostim® is equally effective and safe in HPCM compared to originator G-CSF (Neupogen®) and lenograstim (Granocyte®) in steady-state HPCM setting. 相似文献
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Charles L. Bennett Sumimasa Nagai Andrew C. Bennett Shamia Hoque Chadi Nabhan Martin W. Schoen William J. Hrushesky Stefano Luminari Paul Ray Paul R. Yarnold Bart Witherspoon Josh Riente Laura Bobolts John Brusk Rebecca Tombleson Kevin Knopf Marc Fishman Y. Tony Yang Kenneth R. Carson Benjamin Djulbegovic John Restaino James O. Armitage Oliver A. Sartor 《The oncologist》2021,26(8):e1418-e1426
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The regulation of biosimilars is a process that is still developing. In Europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. It is now more than 3 years since the first biosimilar agents in oncology support, erythropoiesis‐stimulating agents, were approved in the EU. More recently, biosimilar granulocyte colony‐stimulating factors have received marketing approval in Europe. This review considers general issues surrounding the introduction of biosimilars and highlights current specific issues pertinent to their use in clinical practice in oncology. Information on marketing approval, extrapolation, labelling, substitution, immunogenicity and traceability of each biosimilar product is important, especially in oncology where patients are treated in repeated therapy courses, often with complicated protocols, and where biosimilars are not used as a unique therapy for replacement of e.g. growth hormone or insulin. While future developments in the regulation of biosimilars will need to address multiple issues, in the interim physicians should remain aware of the inherent differences between biosimilar and innovator products. 相似文献
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Ylenia Ingrasciotta Janet Sultana Dario Formica Valentina Ientile Andrea Aiello Alessandro Chinellato Daniele Ugo Tari Rosa Gini Maurizio Pastorello Salvatore Scondotto Pasquale Cananzi Giuseppe Traversa Mariangela Rossi Domenico Santoro Gianluca Trifir 《Pharmacoepidemiology and drug safety》2021,30(1):65-77
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《Saudi Pharmaceutical Journal》2022,30(1):39-44
BackgroundThe aim of this study was to evaluate rheumatologists’ perceptions of biosimilar biologics and Non-Medical Switching (NMS).MethodsA cross-sectional survey was conducted among registered members of the Saudi Society for Rheumatology. The questionnaire focused on biosimilars and NMS. Logistic regression was performed to ascertain the effect of demographics and practice characteristics on the use of biosimilars and NMS.ResultsOut of 249 SSR members, 143 completed the survey, generating a response rate of 57.4%. Of those (59.44%) were men with a mean (±SD) age and years of practice of 42.3 ± 9.13 and 10.3 ± 8.9, respectively. Rheumatologists managing adult patients (81.82%) and Ministry of Health practice (43.36 %) were the majority of respondents. Previous experience in prescribing a biosimilar was reported by 43 (30.07%) participants, with a higher probability among women (p = 0.015). A total of 26 (18.18%) participants had performed NMS on eligible patients. Adequate knowledge on biosimilars was reported by 69 (48.25%) participants. The adequacy of evidence to grant biosimilar approval for the studied indication and extrapolation to treat other conditions was reported by 88 (61.5%) and 69 (48.3%), respectively. The concept of totality-of-the-evidence was well understood by 37.1%. Biosimilars had been previously used by 43 (30.07) participants in their practice. NMS had been attempted by 26 (18.18), while 86 (60.1%) participants believed that NMS might harm patients.ConclusionThere is a clear knowledge gap about the biosimilar approval process among adult and pediatric rheumatologists who took part in the survey. In addition, a large number of participants reported having negative opinions about NMS. There is a need to organize SSR-led educational activities, and develop national guidelines regarding biosimilars and NMS. 相似文献
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《Joint, bone, spine : revue du rhumatisme》2014,81(6):471-477
A biosimilar is a biopharmaceutical product intended to be comparable to a previously licensed biopharmaceutical agent. The goal of such products is to increase the accessibility of biopharmaceutical therapy for rheumatoid arthritis by reducing costs. They are not like generic drugs, in that they may differ from the reference products in manufacturing, composition, and formulation. Regulatory authorities strive to ensure the absence of clinically meaningful differences between biosimilars and their reference drugs. However, small molecular differences may potentially affect pharmacodynamics (including affinity), pharmacokinetics, and immunogenicity. Intended copies are non-innovator biopharmaceutical products that, unlike biosimilars, do not have enough clinical evidence to demonstrate biosimilarity. For approval of a biosimilar, most countries require preclinical and clinical studies demonstrating comparability with the reference drug. The margin for determining equivalence or non-inferiority is determined on a case-by-case basis in each country, as there are no general criteria. The European Medicines Agency and US Food and Drug Administration have stringent regulatory processes to ensure comparability of biosimilars with their reference drugs. There are also post-marketing surveillance requirements to monitor safety. Only one biosimilar, CT-P13, has been approved for rheumatoid arthritis. However, in countries with less stringent regulation, intended copies are being commercialized and safety problems have been documented. Consequently, in such countries, there is an urgent need for appropriate regulatory processes to be established. Attempts to close the affordability gap of biopharmaceuticals should not open another gap between patients treated with an innovator drug and an intended copy. 相似文献
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