ESMO Biosimiars Portal: Science

A collection of resources to understand the science behind biosimilars.

Sessions at ESMO congresses in Europe and Asia - webcasts

Are Biosimilars the Key to Access, in Practice? – colloquium during ESMO 2018 to discuss about the use of oncology biosimilars and existing challenges
Oncology Biosimilars in Asia – colloquium during ESMO Asia 2018 focusing on the challenges and opportunities of oncology biosimilars in Asia
ESMO 2017 session on the Incoming Wave of Biosimilars in Oncology & event report Preparing for the Incoming Wave of Oncology Biosimilars – with the imminent arrival of oncology biosimilars, key stakeholders provide their perspective on optimising the uptake of these new agents
ESMO Asia 2017 colloquium on the Incoming Wave of Oncology Biosimilars, in Asia – with the imminent arrival of oncology biosimilars, key stakeholders provide their perspective on optimising the uptake of these new agents in Asia

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

2019

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.

2018

Withdrawal of the EU Marketing Authorisation Applications for Cavoley and Efgratin - On 20 December 2018, STADA Arzneimittel AG officially notified the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cavoley, for reducing neutropenia. On same day, Gedeon Richter Plc officially notified the CHMP that it wishes to withdraw its application for a marketing authorisation for Efgratin, for reducing
FDA Approves Herzuma as a Biosimilar to Herceptin - on 14 December 2018, the US Food and Drug Administration (FDA) approved Herzuma for the treatment of HER2-overexpressing breast
EMA Recommends Granting a Marketing Authorisation for Biosimilar Bevacizumab - on 13 December 2018, the European Medicines Agency (EMA) recommended granting marketing authorisation for Zirabev for the treatment of colon or rectal cancer, breast cancer, NSCLC, RCC and cervical cancer
FDA Approves Truxima as Biosimilar to Rituxan for Non-Hodgkin’s Lymphoma - on 28 November 2018, the US Food and Drug Administration (FDA) approved Truxima as the first biosimilar to Rituxan for non-Hodgkin’s lymphoma to be used as a single agent or in combination with chemotherapy
Biosimilar Medicine Ogivri (Trastuzumab) Received a Positive Opinion from the EMA CHMP - on 18 October 2018, the European Medicines Agency (EMA) recommended granting marketing authorisation for trastuzumab (Ogivri) for the treatment of breast and gastric cancer
EMA Recommends Granting a Marketing Authorisation for Biosimilar Pegfilgrastim - on 26 July 2018, the European Medicines Agency (EMA) recommended granting marketing authorisation for Pelgraz and Udenyca intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy
EMA Recommends Granting a Marketing Authorisation for Trazimera - on 31 May 2018, the European Medicines Agency (EMA) recommended granting marketing authorisation for Trazimera for the treatment of breast and gastric cancer
FDA Approves Fulphila to Decrease the Risk of Infection During Cancer Treatment - on 4 June 2018, the US Food and Drug Administration (FDA) approved Fulphila as a biosimilar to Neulasta
FDA Approves Retacrit as a Biosimilar to Epogen/Procrit - on 15 May 2018, the US Food and Drug Administration (FDA) approved Retacrit as a biosimilar to Epogen/Procrit for the treatment of anaemia due to effects of concomitant myelosuppressive chemotherapy
EMA Recommends Granting a Marketing Authorisation for a Biosimilar Trastuzumab (Kanjinti) - on 22 March 2018, the European Medicines Agency (EMA) recommended granting marketing authorisation for Kanjinti, intended for the treatment of breast and gastric cancer

2017

EMA Recommends Approval of Herzuma for the Treatment of Breast and Gastric Cancer - on 14 December 2017, the European Medicines Agency (EMA) recommended granting marketing authorisation for Herzuma as a biosimilar to Herceptin (trastuzumab) for the treatment of breast and gastric cancer
FDA Approves Ogivri as a Biosimilar to Herceptin - on 1 December 2017, the US Food and Drug Administration (FDA) approved Ogivri as a biosimilar to Herceptin for the treatment of patients with breast and gastric cancer whose tumours overexpress the HER2 gene
Withdrawal of the Marketing Authorisation Application for Biosimilar Bevacizumab (Kyomarc) - on 17 October 2017, Amgen Europe BV officially notified the European Medicines Agency (EMA) that it wishes to withdraw its application for a marketing authorisation for Kyomarc for marketing reasons
EMA Recommends Approval of Biosimilar Bevacizumab - on 9 November 2017, the European Medicines Agency (EMA) recommended the granting of marketing authorisation for Mvasi
EMA Recommends Granting a Marketing Authorisation for Trastuzumab Biosimilar - on 14 September 2017, the European Medicines Agency (EMA) recommended granting marketing authorisation for the biosimilar trastuzumab Ontruzant
FDA Approves a Biosimilar to Bevacizumab – on September 2017, the US Food and Drug Administration (FDA) approved Mvasi as a biosimilar to Avastin
ESMO 2017: Biosimilar Rituximab Shows Equivalent Efficacy to Reference Rituximab in Previously Untreated Advanced Follicular Lymphoma - Biosimilar GP2013 demonstrated an equivalent overall response rate compared to the reference drug rituximab in the ASSIST-FL study
FDA ODAC Recommends Biosimilar Bevacizumab and Trastuzumab - on 13 July 2017, the US Food and Drug Administration’s (FDA) recommended approval of biosimilar versions of bevacizumab (Avastin) and trastuzumab (Herceptin)
Three Biosimilar Medicines with Rituximab as Active Substance Received a Positive Opinion from EMA - on 18 May 2017, the European Medicines Agency (EMA) recommended granting a marketing authorisation for 3 biosimilars to rituximab – Blitzima, Tuxella, Ritemvia
EMA Recommends Approval of Two Biosimilar Medicines – Biosimilar Rituximab - on 21 April 2017, the European Medicines Agency (EMA) recommended granting marketing authorisation for 2 biosimilars to rituximab - Rixathon and Riximyo
Withdrawal of the Marketing Authorisation Application for Zioxtenzo (Pegfilgrastim) - on 18 January 2017, Sandoz GmbH officially notified the European Medicines Agency (EMA) that it wishes to withdraw its application for a marketing authorisation for Zioxtenzo

2016

EMA Tailored Scientific Advice to Support Step-by-Step Development of New Biosimilars - The European Medicines Agency (EMA) announced on 16 December 2016 that it will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines
EMA Recommends Granting a Marketing Authorisation for Biosimilar Rituximab - on 15 December 2016, the European Medicines Agency (EMA) recommended granting marketing authorisation for the biosimilar Truxima
Controversy of the Day Biosimilars and bioequivalents: A wise choice in a demanding treatment landscape? – article about the escalating costs of cancer care and the need for biosimilars published in October 2016

2014 and 2015

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