Bron: Axon Healthcare Lilly is gestart met de Europese lancering van Abasaglar (biosimilar Lantus). Ondertussen komt de uptake van Remsima en Inflectra op gang, is de overname van Hospira door Pfizer bijna afgerond en ontwikkelt Samsung Bioepis zich … [Lees meer...] overAbasaglar, Remsima, Inflectra, Hospira, Bioepis, MabThera, Herceptin & Humira
WHO issues draft proposal for its biological qualifier
The World Health Organization (WHO) first introduced the concept of a biological qualifier (BQ) for naming biologicals back in 2014. Now the body has issued a draft proposal covering the issue of how to name biologicals, including biosimilars. The … [Lees meer...] overWHO issues draft proposal for its biological qualifier
Clinical programmes for anti-TNF biosimilars
Biosimilars for anti-tumour necrosis factor (anti-TNF) drugs are currently under development. These include biosimilars of blockbusters such as AbbVie’s Humira (adalimumab), Amgen’s Enbrel (etanercept) and Johnson & Johnson’s Remicade … [Lees meer...] overClinical programmes for anti-TNF biosimilars
Phase I results for candidate adalimumab, etanercept and infliximab biosimilars
Results of phase I clinical studies of candidate adalimumab biosimilar SB5, etanercept biosimilar SB4 and infliximab biosimilar SB2, demonstrated equivalence safety profiles to their originator biologicals in healthy subjects [1-3]. The phase I, … [Lees meer...] overPhase I results for candidate adalimumab, etanercept and infliximab biosimilars
Regulering van biosimilars op Europees en nationaal niveau
Het octrooi van veel succesvolle biologische geneesmiddelen is (bijna) verlopen. Andere producenten kunnen hun versie, een biosimilar, van een succesvol biologisch geneesmiddel ontwikkelen. Het Europese Geneesmiddelen Bureau (EMA) heeft voortvarend … [Lees meer...] overRegulering van biosimilars op Europees en nationaal niveau
Proposals to lessen the shortage of essential cancer drugs, generics and biosimilars in the US and the world
Essential cancer and supportive drug shortage in the US seriously affects cancer care, and increases cost pressure on the health system. These drugs are mostly off-patent generics. Collaborative efforts of FDA, pharmacists, physicians and … [Lees meer...] overProposals to lessen the shortage of essential cancer drugs, generics and biosimilars in the US and the world
Achtergrondinformatie Educational Meeting on Biosimilar Monoclonal Antibodies
Biosimilars zijn versies van bestaande biotech merkgeneesmiddelen die qua werkzaamheid en veiligheid niet verschillen van het originele merkartikel. Biosimilars kunnen tot de markt worden toegelaten als de kwaliteit, veiligheid en werkzaamheid is … [Lees meer...] overAchtergrondinformatie Educational Meeting on Biosimilar Monoclonal Antibodies
Introducing biosimilar versions of infliximab: Inflectra and Rcmsima
Bron: National Institute for Health and Care Excellence (NICE) This resource has been developed to provide practical information and advice on the use of biosimilar versions of infliximab (Inflectra and Remsima). It is intended for use by both … [Lees meer...] overIntroducing biosimilar versions of infliximab: Inflectra and Rcmsima
Norway, biosimilars in different funding systems
Norway has approved biosimilar versions of the biologicals somatropin, epoetin, filgrastim and infliximab. Epoetin and filgrastim are included in a national tender for drugs used in hospitals, in which prices can be reduced by up to 89%. Regional … [Lees meer...] overNorway, biosimilars in different funding systems
Productie van biosimilars
Het maken van biosimilars leek een logische keuze voor Synthon, een Nederlandse geneesmiddelenfabrikant die groot is geworden met het maken van generieke medicijnen (kopieën van chemische medicijnen). Toch heeft Synthon zijn ambitie om ook de markt … [Lees meer...] overProductie van biosimilars
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