BIOSIMILARS: BUSINESS REVIEW

Abstract

A quarterly review that will help you navigate through the twists and turns of the emerging biosimilar market.

A business review of, and commentary on, the developments that are shaping this rapidly evolving and often contentious sector of the generic drug industry.

Few areas of the generics market are proving as troublesome to develop as biosimilars. Unable to replicate reference products in the usual manner, companies are grappling with both production issues and regionally variable regulatory demands.

Whereas the EU has outlined a settled policy and regulatory pathway, the USA is at a far earlier stage. The FDA has proved unwilling to act without legislation in Congress, which is only in 2007 appearing as a practical proposition.

But these issues must be resolved. The number of biotech-based products coming off patent will increase steadily; indeed, the time may not be far off when almost all newly-developed drugs are biologics, not small-molecule chemicals.

Industry executives, regulators and commercial management operating in or monitoring this developing sector need to stay in close touch and, more importantly, be able to assess the significance of developments in a broader industry context.

That is why Espicom Business Intelligence, the leading provider of generic drug business data, has launched BIOSIMILARS. This well written quarterly review will help you navigate through the twists and turns of the emerging biosimilar market. Packed with the latest industry and regulatory developments, company profiles and keen insightful commentary, it is essential reading for everyone involved or interested in biosimilars.