Oncology Central

Biosimilar monoclonals have landed in oncology

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Introduction

The role of monoclonal antibodies (“monoclonals”) and their derivatives, is rapidly increasing in the pharmacotherapy of cancer. Hundreds of monoclonals are under development worldwide, oncology being the main area of development. This is good news for cancer patients since some of the future anti-cancer monoclonals will bring major therapeutic advances.

Unfortunately, the costs of cancer pharmacotherapy have risen steeply, partly because of the increased use of anti-cancer monoclonals. The rapid influx of new expensive monoclonals and other break through therapies threatens the sustainability of cancer pharmacotherapy.

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Biography

Pekka_Portrait_lähiPekka Kurki, M.D, Ph.D, acted as a research professor at the Finnish Medicines Agency (Fimea) until retirement in June 2016. Before joining the Finnish regulatory agency in 1997, he worked in the pharmaceutical industry (clinical research), both in Europe and in the U.S.A. Dr. Kurki’s clinical speciality is internal medicine with sub-speciality in rheumatology. He has a teaching affiliation to the University of Helsinki (adjunct professor of clinical immunology). He has had several scientific positions at the European Medicines Agency (EMA), including the membership the Committee of Human Medicinal Products (CHMP, 2000-7), chairmanships of the working parties for comparability (2002-3), biosimilars (BMWP, 2004-7), cell therapy (2002-4), and cell-based medicinal products (CPWP 2005-7). He is an expert of the Finnish Medicines Agency and the European Medicines Agency.

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