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 +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 +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 +3 more
doaj +1 more source
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 +6 more
wiley +1 more source
Advances in paediatrics in 2016: Current practices and challenges in allergy, autoimmune diseases, cardiology, endocrinology, gastroenterology, infectious diseases, neonatology, nephrology, neurology, nutrition, pulmonology [PDF]
, 2017 This review reports main progresses in various pediatric issues published in Italian Journal of Pediatrics and in international journals in 2016. New insights in clinical features or complications of several disorders may be useful for our better ...
Bernasconi, Sergio +5 more
core +3 more sources
Regulatory Evaluation of Biosimilars : Refinement of Principles Based on the Scientific Evidence and Clinical Experience [PDF]
, 2022 Publisher Copyright: © 2022, The Author(s).The World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert Committee on Biological Standardization (ECBS) in ...
Ekman, Niklas +5 more
core +1 more source
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 +5 more
wiley +1 more source
Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland [PDF]
, 2017 Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in ...
Bermingham, Margaret +6 more
core +1 more source
Long-term safety and effectiveness of a somatropin biosimilar (Omnitrope®) in children requiring growth hormone therapy: analysis of final data of Italian patients enrolled in the PATRO children study [PDF]
Purpose Omnitrope® (a somatropin biosimilar), used to treat growth disturbances, is considered to have a good safety profile in children. Here, we present the analysis of final data of the Italian cohort of the PAtients TReated with Omnitrope® (PATRO ...
Antoniazzi F +19 more
core +4 more sources