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European Biopharmaceutical Review

The Emergence of Biogenerics

Investors have big hopes for the generics industry. The market capitalisation of leading generics companies increased during the last decade, more so than that of major pharma companies, resulting in return-to-shareholders-to-earnings ratios close to the pharma average. This outperformance indicates the expectations for the future of the generics industry. Although many changes in industry structure are expected to trigger strong growth - such as internationalisation of European companies; consolidation; and innovation in pharmaceutical drug development - the most prominent challenge so far is the product pipeline.A look at published drug patent tables reveals a huge wave of patent expiry over the next four years, worth an estimated US$40 billion in product sales, and including as many as 18 blockbusters (1). For the first time, these tables also include pharmaceuticals that were biotechnologically developed and produced. These biopharmaceuticals are also expected to be launched by generics companies, as they account for about one-quarter of the US$40 billion total and represent one of the fastest growing segments in the pharmaceutical market (see Figure 1). In fact, 'biogenerics' will represent a US$2 billion market for the generics industry, assuming a similar penetration rate as that for traditional drugs.


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By Klaus Maleck, Chief Financial Officer, and Federico Pollano, Head
of Business Development, at BioGeneriX AG

Dr Klaus Maleck studied biotechnology in Braunschweig, Strasbourg and Chapel Hill, and holds a PhD in Biochemistry from the Max-Planck-Institute in Cologne. After four years as a Genomics Scientist at Novartis Inc. in the US, he joined the McKinsey team in Munich to consult diverse life science companies on strategy and M&A activities. He is currently employed as Chief Financial Officer at BioGeneriX AG.
Federico Pollano started his career (after studying biology and computer science) in clinical research for the Zambon group in Munich. He then worked for Glaxo Wellcome in clinical research, pharmacoeconomics and disease management fields, before joining the business development unit in Germany, focusing on licensing and M&A. In 2001, he took over as Head of Business Development at BioGeneriX AG.

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Klaus Maleck
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Federico Pollano
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