Results 11 to 20 of about 148 (67)

Ten years of biosimilar recombinant human growth hormone in Europe [PDF]

Drug Design, Development and Therapy, 2017
Paul Saenger Division of Pediatric Endocrinology, Department of Pediatrics, Winthrop University Hospital, Mineola, NY, USA Abstract: Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years.
Saenger P
doaj   +2 more sources

Ten years of clinical experience with biosimilar human growth hormone: a review of safety data [PDF]

Drug Design, Development and Therapy, 2017
Maria Victoria Borrás Pérez,1 Berit Kriström,2 Tomasz Romer,3 Mieczyslaw Walczak,4 Nadja Höbel,5 Markus Zabransky5 1Hospital General de Granollers, Granollers, Barcelona, Spain; 2Department of Clinical Sciences, Pediatrics, Ume ...
Borrás Pérez MV, Kriström B, Romer T, Walczak M, Höbel N, Zabransky M   +5 more
doaj   +2 more sources

WHO guidelines on biosimilars: Toward improved access to safe and effective products

Annals of the New York Academy of Sciences, Volume 1521, Issue 1, Page 96-103, March 2023., 2023
Abstract The World Health Assembly resolution on access to biotherapeutics in 2014 urges WHO and Member States to facilitate access to biotherapeutics while ensuring their quality, safety, and efficacy. While efforts to date have contributed to increased availability and better access to biotherapeutics, including biosimilars, huge gaps still remain ...
Hye‐Na Kang, Meenu Wadhwa, Ivana Knezevic, Clive Ondari, Mariangela Simao   +4 more
wiley   +1 more source

The history, physiology and treatment safety of growth hormone

Acta Paediatrica, Volume 111, Issue 2, Page 215-224, February 2022., 2022
Abstract Growth hormone treatment was introduced in the 1950s to address growth disturbances and metabolic abnormalities. Hundreds of thousands of children have been treated, with gradual expansion of treatment indications. From initially being offered only to patients with severe growth hormone deficiency, today many children are treated for ...
Anders Tidblad
wiley   +1 more source

Regulatory challenges with biosimilars: an update from 20 countries

Annals of the New York Academy of Sciences, Volume 1491, Issue 1, Page 42-59, May 2021., 2021
Abstract The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices.
Hye‐Na Kang, Robin Thorpe, Ivana Knezevic, Mary Casas Levano, Mumbi Bernice Chilufya, Parichard Chirachanakul, Hui Ming Chua, Dina Dalili, Freddie Foo, Kai Gao, Suna Habahbeh, Hugo Hamel, Gi Hyun Kim, Violeta Perez Rodriguez, Desi Eka Putri, Jacqueline Rodgers, Maria Savkina, Oleh Semeniuk, Shraddha Srivastava, João Tavares Neto, Meenu Wadhwa, Teruhide Yamaguchi   +21 more
wiley   +1 more source

Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009–2019

Pharmaceuticals, 2021
Since the first biosimilar medicine, Omnitrope® (active substance somatropin) was approved in 2006, 53 biosimilars have been authorized in Spain. We estimate the budget impact of biosimilars in Spain from the perspective of the National Health System ...
Manuel García-Goñi, Isabel Río-Álvarez, David Carcedo, Alba Villacampa   +3 more
doaj   +1 more source

The Effect of 3‐Month Growth Hormone Administration and 12‐Month Follow‐Up Duration among Heart Failure Patients Four Weeks after Myocardial Infarction: A Randomized Double‐Blinded Clinical Trial

Cardiovascular Therapeutics, Volume 2021, Issue 1, 2021., 2021
Background. The probable impact of growth hormone (GH) as a heart failure (HF) treatment strategy is still less investigated. Therefore, we aimed to evaluate the relation of 3‐month GH prescription on left ventricular ejection fraction (LVEF), interventricular septum (IVS), posterior left ventricle (LV) thickness, end systolic and end diastolic ...
Afshin Amirpour, Mehrbod Vakhshoori, Reihaneh Zavar, Hadi Zarei, Masoumeh Sadeghi, Behzad Yavari, Brian Tomlinson   +6 more
wiley   +1 more source

Cancer treatment with biosimilar drugs: A review. [PDF]

Cancer Innov
With crucial mutational categories, biosimilar drug prototypes, and clinical practices including blood and liquid biopsy, cell therapy, gene therapy, recombinant therapeutic proteins, and tailored pharmaceuticals, it aids in targeting certain organs.
Malakar S, Gontor EN, Dugbaye MY, Shah K, Sinha S, Sutaoney P, Chauhan NS.   +6 more
europepmc   +2 more sources

The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review

Clinical Pharmacology &Therapeutics, Volume 108, Issue 4, Page 734-755, October 2020., 2020
To date, no consensus exists among stakeholders about switching patients between reference biological products (RPs) and biosimilars, which may have been curbing the implementation of biosimilars in clinical practice. This study synthesizes the available data on switching and assesses whether switching patients from a RP to its biosimilar or vice versa
Liese Barbier, Hans C. Ebbers, Paul Declerck, Steven Simoens, Arnold G. Vulto, Isabelle Huys   +5 more
wiley   +1 more source

Reversal of epigenetic aging and immunosenescent trends in humans

Aging Cell, Volume 18, Issue 6, December 2019., 2019
Epigenetic aging—an accurate measure of biological aging in humans—can run in reverse. A thymus regeneration protocol has enabled estimated biological age to decrease in healthy 51‐ to 65‐year‐old men by 1.5 years after 1 year of treatment (or by 2.5 years compared to chronological age). This significantly exceeds the heretofore theoretical concept of “
Gregory M. Fahy, Robert T. Brooke, James P. Watson, Zinaida Good, Shreyas S. Vasanawala, Holden Maecker, Michael D. Leipold, David T. S. Lin, Michael S. Kobor, Steve Horvath   +9 more
wiley   +1 more source