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A Guide to Biosimilars, Biogenerics and Follow-On Biologics
Informa Healthcare, Jan 2007, Pages: 237
This report will give readers a broad overview of the key drivers and players involved in the biosimilars revolution today. It will also arm readers with the strategic information they need to face the new opportunities presented by this market trend, as well as its challenges.
With regulation playing a key role in the evolving landscape for biosimilar products, the report places particular emphasis on the regulatory situation in two of the largest markets; the US and Europe. While the European regulatory framework for biosimilars is more defined, there have been significant developments in the US too, notably the FDAs approval of Omnitrope, which demostrated that the simplified approval process is available to biosimilars that demostrate comparability with biologics regulated under NDAs. The report discusses the various factors at play in these two markets.
It analyses the situation from the perspectives of both biosimilar manufacturers and innovator companies. For firms looking to develop biosimilars, some 75 proteins and peptide therapeutics were recently identified as potential profitable targets for new products. And significantly, a substantial proportion of these were approved as NDAs, meaning that biosimilar firms can target them knowing that a clear regulatory pathway exists.
Originator companies, meanwhile, are looking to use a range of strategies to delay biogeneric competition; these strategies include patenting preferred formulations, manufacturing methods and protein modifications.
The report will spotlight the most prominent companies in the biosimilars field, not only the well established generics manufacturers but emerging biosimilar developers too. It will also assess the various geographical markets for therapeutic proteins, including North America, Europe and Brazil.
Use this report provides:
- an overview of the market for therapeutic proteins, including growth factors, anticoagulants, insulins, interferons, hormones, enzymes and vaccines
- an analysis of the drivers of the nascent biosimilars market and current obstacles to entry
- a review of the global regulatory situation; essential knowledge for any company looking to introduce biosimilar products to market
- sales and patent expiry information on the products identified as profitable targets for biosimilars
- an examination of the issues involved in assessing the similarity of biosimilars and in the prediction of immunogenicity
- profiles of the most active companies in the biosimilars field - their pipelines, business strategies and collaborations in the biosimilars space
- assessments of factors such as the level of competition, ease of product development and characterisation and the level of patient support required, to predict the market potential for different classes of biosimilars
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