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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 Grants a Marketing Authorization for Two Biosimilar Medicines, Bevacizumab - On 28 January 2021, 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 two biosimilar medicinal products, bevacizumab (Alymsys) and bevacizumab (Oyavas), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
  • EMA Recommends Granting a Marketing Authorisation for a Biosimilar Bevacizumab, Onbevzi - On 12 November 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 Onbevzi, intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell carcinoma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
  • EMA Recommends Granting a Marketing Authorisation for Equidacent - On 23 July 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 Equidacent, a biosimilar bevacizumab, intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell cancer (RCC), epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
  • EMA Recommends Granting A Marketing Authorisation for Biosimilar Bevacizumab - On 25 June 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 Aybintio (bevacizumab), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell cancer (RCC), epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
  • EMA Recommends Granting A Marketing Authorisation for Biosimilar Trastuzumab - On 28 May 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 Zercepac, intended for the treatment of breast and gastric cancer.
  • WHO Prequalifies Rituximab Biosimilar Medicine - On 25 May 2020, the World Health Organization (WHO) prequalified its first rituximab biosimilar product, intended for the treatment of large B-cell lymphoma, chronic lymphocytic leukaemia and follicular lymphoma.
  • 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).
News from past years
  • WHO Prequalifies Biosimilar Trastuzumab - On 18 December 2019, the World Health Organization (WHO) prequalified its first biosimilar medicinal product, trastuzumab, intended for the treatment of breast cancer.
  • 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.
  • FDA Approves First Biosimilar Product in the USA - on 6 March 2015, the US Food and Drug Administration (FDA) approved Zarxio, the first biosimilar product approved in the United States
  • Anticancer Medicines Recommended for Approval by EMA in 2014 – in 2014 the European Medicines Agency (EMA) approved biosimilar filgrastim for the management of febrile neutropenia in patients treated with cytotoxic chemotherapy
  • Facilitating Global Development of Biosimilars - the European Medicines Agency (EMA) has published its revised overarching guideline on biosimilars that enter into force as of 30 April 2015

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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