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ESMO Biosimilars Portal: Science

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A collection of resources to understand the science behind biosimilars.

Sessions at ESMO congresses in Europe and Asia - webcasts

Scientific news on biosimilars

  • EMA Recommends Granting a Marketing Authorisation for Biosimilar Rituximab - On 30 January 2020, the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ruxience (rituximab), intended for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and Pemphigus vulgaris (PV).
  • EMA Recommends Granting a Marketing Authorisation for New Biosimilar Pegfilgrastim - On 26 April 2019, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product pegfilgrastim (Grasustek), intended for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy.
  • NICE Issues Technology Appraisal Guidance for Pertuzumab - On 20 March 2019, NICE issued Technology appraisal guidance [TA569] with evidence-based recommendations on pertuzumab (Perjeta, Roche) for adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults at high risk of recurrence. 
News from past years

News from other sources

  • European Commission multi-stakeholder workshop on biosimilars – annual meeting to promote the exchange of knowledge and best practices in biosimilars' use and uptake (ESMO chaired sessions in 2017 and 2018)
  • Generics and Biosimilars Initiative (GaBI) - GaBI Online is a resource for global news on the recent developments in the field of generics and biosimilars, a repository of worldwide guidelines and an archive of related scientific information

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