Search results for monoclonal antibodies

Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?

Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ankit Ranpura1, MD; Kuldeep Kumar1, PhD; Elena Wolff-Holz2, MD Abstract: Ethnic sensitivity assessments in the form of bridging pharmacokinetics (PK) studies are often needed for biosimilar monoclonal antibodies (mAbs) to meet regulatory requirements in regions like […]

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Roundtable on registries: practical considerations for registries – making them work, London, UK, 26 January 2017

Author byline as per print journal: Stuart Bloom, DM, FRCP; Keith Bodger, MBChB(Honours), MD, FRCP; Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP; Professor Sarah Garner, BPharm, PhD; Professor Kimme Hyrich, MD, PhD, FRCPC; Clare Jacklin; Professor John G Williams, CBE, FRCP Introduction: Registries collect clinical data to evaluate specified outcomes for a population defined by a particular disease, condition […]

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New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications

Author byline as per print journal: Valderílio Feijó Azevedo1,2, Alejandra Babini3,4, Fabio Vieira Teixeira5,6, Igor Age Kos1,2, Pablo Matar7 Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, to present and discuss recent […]

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Life begins at forty – hybridomas: ageing technology holds promise for future drug discoveries

Abstract: Hybridomas were developed in 1975 as a stable platform for creating monoclonal antibodies (mAbs). Over the past 40 years, hybridomas have been a leading platform for creating mAbs, yet of the 50 commercial mAbs approved for sale by the US Food and Drug Administration (FDA), only 18 are produced using hybridomas. Of the remainder, […]

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Interchangeability. An insurmountable fifth hurdle?

Abstract: The arrival of biosimilars has led to considerable debate on how they can be used in clinical practice. A particular concern is related to the question of whether a biosimilar can be safely interchanged with the originator product or other biosimilars. Here we will discuss challenges to the regulatory approach for establishing interchangeability, in […]

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Biosimilar monoclonal antibodies—challenges and opportunities in Europe

Abstract: New regulations for the development of biosimilars have been introduced in Europe and a new class of biosimilars – monoclonal antibodies – is expected on the market soon, which will both challenge and benefit our healthcare systems. Submitted: 3 June 2013; Revised: 16 July 2013; Accepted: 23 July 2013; Published online first: 5 August […]

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