Results 41 to 50 of about 16,304 (256)
Why is there no biosimilar of Erbitux®?
Journal of Pharmaceutical and Biomedical Analysis, 2023 Monoclonal antibody (mAb)-based therapies have been a major advance in oncology patient care, even though they represent a significant healthcare cost. Biosimilars, launched in Europe in 2004 are an economically attractive alternative to expensive originator biological drugs. They also increase the competitiveness of pharmaceutical development.
Douez, Emmanuel +7 more
openaire +4 more sources
British Journal of Clinical Pharmacology, EarlyView.Aim Osteoporosis is a prevalent skeletal disease characterized by low bone mass and increased fracture risk. Management of osteoporosis typically involves antiresorptive and anabolic therapies, which are reimbursed in Ireland through various drug schemes.
Amelia Smith +4 more
wiley +1 more source
Journal of Oncology Practice, 2017 Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference ...
openaire +3 more sources
British Journal of Clinical Pharmacology, EarlyView.Aims Amgevita is a licensed biosimilar to adalimumab, having demonstrated high pharmacokinetic and clinical similarity to Humira. Switching to a lower‐cost medicine may elicit a nocebo effect, whereby expectations of poorer efficacy impact outcomes despite pharmacological similarity. This prospective cohort study examined clinical and economic outcomes
Louise Rabbitt +7 more
wiley +1 more source
Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries
Frontiers in Pharmacology, 2017 Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries ...
Paweł Kawalec +11 more
doaj +1 more source
Journal of Dermatological Treatment, 2015 Biological drugs are large, complex glycoprotein molecules produced in living organisms. Revolutionary treatments for many conditions, biologics used in dermatology will face patent expiration, opening opportunities for competitive versions. Biologic drugs are so complex such that it is impossible to reproduce them exactly.
Caleb R King +2 more
openaire +3 more sources
Biosimilars and Regulatory Authorities [PDF]
Nephron Clinical Practice, 2010 The patent expirations for many biotechnological medicines have prompted the development of copies of biological medicinal products. Unlike generics, biosimilars are similar but not identical to their reference product, because their chemical characteristics are directly related to the manufacturing process which cannot be precisely duplicated.
P. Minghetti +3 more
openaire +3 more sources
British Journal of Clinical Pharmacology, EarlyView.Abstract Aim The aim of this paper is to describe a proposal for an algorithm to guide decision making on which cohorts in early phase pharmacology trials should employ a sentinel approach, thereby standardising and harmonising practices, and improving decision making around sentinel dosing.
Jules A. A. C. Heuberger +5 more
wiley +1 more source
Blood Advances, 2017 : Immunogenicity of biotherapeutics and the elicitation of anti-drug antibodies are a key concern for their efficacy, pharmacokinetics, and safety.
Tina Rubic-Schneider +11 more
doaj
Annals of Oncology, 2008 The purpose of this report was to review issues associated with the introduction of alternative versions of biosimilars used in the oncology setting.Data were obtained by searches of MEDLINE, PubMed, references from relevant English-language articles, and guidelines from the European Medicines Agency.When biosimilars are approved in EU, they will be ...
Håkan Mellstedt +2 more
openaire +3 more sources