Results 51 to 60 of about 15,630 (215)
Biosimilar: what it is not [PDF]
British Journal of Clinical Pharmacology, 2015 A biosimilar is a high quality biological medicine shown to be in essence the same as an original product. The European Medicines Agency (EMA) paved the way in the regulatory arena by creating a safeguarding framework for the development of biosimilars.
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Biosimilar therapeutics: what do we need to consider? [PDF]
, 2009 Patents for the first generation of approved biopharmaceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as ‘biosimilars’ (European Union) or ‘follow-on protein products’ (United States).
Schellekens, H.
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Nature Communications, 2018 The specific glycosylation patterns of biological drugs often impact the efficacy and safety of the therapeutic product. Here the authors describe a native mass spectrometry approach that allows the resolution of highly complex glycosylation patterns on ...
Therese Wohlschlager +7 more
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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 ...
H, Mellstedt, D, Niederwieser, H, Ludwig
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Generic and biosimilar medicines: quid? [PDF]
, 2012 Once intellectual property protection, data and marketing exclusivity of reference medicines have expired, generic medicines and biosimilar medicines can enter the off-patent market.
Simoens, Steven
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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.
Palak K, Patel +2 more
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Journal of Pharmaceutical Health Care and Sciences, 2019 Background Infliximab (IFX) has changed the management of many life-threatening immune-mediated diseases. The high cost of IFX and its patent expiry have led to pharmaceutical companies developing a biosimilar; however, its safety profile remains unknown
Iku Niinomi +6 more
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Frontiers in Pharmacology, 2022 Objective: The ORIENT-32 clinical trial revealed that sintilimab plus bevacizumab biosimilar significantly improved the median progression-free survival and median overall survival (OS) compared with sorafenib.
Ye Peng +10 more
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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 ...
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Arthritis &Rheumatology, EarlyView.Objective To assess guselkumab + golimumab combination therapy versus guselkumab monotherapy in participants with active psoriatic arthritis (PsA) and inadequate response to tumor necrosis factor inhibitors (TNFi‐IR). Methods Adults with active TNFi‐IR PsA (three or more tender/swollen joints) were randomized (2:1) to subcutaneous guselkumab (100 mg) +
Jose U. Scher +12 more
wiley +1 more source