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.
