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European Biopharmaceutical Review

Following a Similar Path

While the European Union is leading the way in bringing similar biological medicinal products, or ‘biosimilars’, to patients in need, activity in the past year signals a greater push in the US on this front, claims Suzanne Sensabaugh at MDS Pharma Services

The US Food and Drug Administration (FDA) has demonstrated its willingness to work with Congress to establish a pathway for follow-on protein products (FOPPs) – the term the US has selected for biosimilar products. Also in the budget for the fiscal year 2009, US President George Bush has proposed that the FDA be given the authority to establish this pathway (1). Considering these recent events, now is a relevant time to reflect on how biosimilars came to the market in the EU, what we have learned in the development of these drugs, and the current situation in the US.

BIOSIMILARS IN THE EU

Sustainability of national healthcare systems and the need for competition in the field of biotechnology-derived medicines were strong drivers of the establishment of the legal pathway for biosimilars in the EU (2). In 2003, the requirements for biosimilars were placed in the section of the law reserved for abbreviated applications. In 2004, legislation was enacted clarifying that results of testing related to safety (preclinical) or to efficacy (clinical), or indeed both, were required for approval. During the European Medicines Agency’s (EMEA) normal course of business of reviewing confidential data and making decisions on biosimilar dossiers, they obtained the necessary information to draft guidance documents. The guidance documents described the basic principles and concepts of similar biological medicinal products. Productspecific guidelines were also drafted which detailed nonclinical and clinical requirements for recombinant Erythropoetin (EPO), Somatropin (human growth hormone), Granulocyte-Colony Stimulating Factor (G-CSF), and Insulin.


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Suzanne M Sensabaugh is VP, Biopharmaceutical Development, MDS Pharma Services, where she is responsible for managing and directing the consulting group in Development & Regulatory Services and providing professional guidance to clients. Prior to this position, she was VP, Regulatory Affairs, and Senior Director for Global Biogenerics, Teva Pharmaceutical Industries Ltd, where she developed regulatory strategy and submissions for biotechnology products. She has more than 10 years of experience at the FDA/CBER as a researcher, product reviewer and inspector for biologics. She has additional experience in the industry as Associate Director, Regulatory Affairs, Genzyme Corporation, and as VP, RA and Quality at the Biotechnology Division of SICOR Inc. She also teaches clinical development at Johns Hopkins University. She received her MBA from Duke University, MS in Biotechnology from Johns Hopkins University, and BS in Zoology from the University of Maryland
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