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BioForum Release: Regulatory Requirements and European Approval Process of Biosimilar Products From the Point of EMEA

4/24/2012 9:59:23 AM

April 24, 2012 -- Biosimilars is a term used to describe officially-approved subsequent versions of innovator biopharmaceutical products. The simplest definition of Biopharmaceuticals says that they are medical drugs produced using biotechnology. They can include proteins, nucleic acids and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation. They can be used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.

'Human' insulin made via recombinant DNA technology was the first biopharmaceutical substance approved for therapeutic use. Humulin (trade name sometimes referred to as rHI), was developed by Genentech, but licensed to Eli Lilly and Company, who manufactured and marketed the product starting in 1982.

But the way from discovery of new biopharmaceutical, through passing approval processes, finally to registration of new Biosimilar is very long and complicated. The development process of biopharmaceuticals is risky, lengthy, complex and expensive. Registration is hindered by the natural diversity of biopharmaceuticals. Moreover, biopharmaceuticals usually are effective in a subgroup of the patient population, and there is a need to select the most flexible target population and to identify biomarkers. The development process also needs to collect comparative data to calculate the incremental cost effectiveness and budget impact of biopharmaceuticals. There is a role for innovative mechanisms such as risk-sharing arrangements to reimburse biopharmaceuticals.

These and other issues will be discussed during the session, “Biosimilars and new biotech products – Market and Development Opportunities in Central Europe” as part of this year’s CE BioForum (23-24th May, Brno, Czech Republic). During this discuss panel Martin Votava, Director of Regulatory Affairs at European Pharminvent Services, Ltd., a former Member of the Committee for Medicinal Products for Human Use, Scientific Committee at the European Medicines Agency, an expert in pharmacology and regulatory science in the EU will be speaker in his lecture “Regulatory Requirements and European Approval Process of Biosimilar Products”. Companies very often underestimate the need of detailed and clear interpretation of clinical study results which may subsequently cause narrowing indication of biosimilar product compared to originator. This will be particularly an issue for biosimilar monoclonal antibodies where the discussion about extrapolation of study results is still open- says Martin Votava,.

This year, BioForum – Central European Forum of Biotechnology and Innovative BioEconomy, will be in its 11th annual edition. The event focuses on following issues: business models in personalised medicine, biosimilars and new biotech products, and clinical and preclinical research opportunities in Central Europe. The organizer of Bio-Forum is Bio-Tech Consulting from Lodz, Poland (

BioForum - Central European Forum of Biotechnology & Innovative BioEconomy together with accompanying events will be held on 23-24th of May 2012 in the Conference Centre BVV Trade Fairs in Brno (Czech Republic).


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