March 2007

This follow-up to my post on the technical reasons why biogenerics are so hard to regulate provides some updates the status of biogenerics, background on the key issues, and the impacts on the industry of the various possible approval schemes. Clinical Trials The clinical trial requirement for biogenerics is the leading issue from a regulatory [...]

Biotechnology companies have been facing a widening funding gap. Between frozen federal research budgets and a growing focus among venture capitalists and senior partners for larger, more mature, biotechnology firms – at the expense of smaller ones – a funding gap is growing between basic research and initial proof-of-principle commercial research. So, who fills the [...]

Countries use various methods to control drug expenditures. Beyond simple negotiation, countries can also implement price controls or use WTO-authorized compulsory licensing, which enables a country to produce generic versions of branded drugs if they face a health crisis without violating international patent agreements. The United States threatened to use compulsory licensing to acquire cheap [...]

There’s been a lot of press floating around lately about the push to develop a framework for biogeneric (or biosimilar, or follow-on, etc.) approvals. Why are biogenerics so hard to regulate? Why can’t they just follow the same path as traditional generic drugs? The answer lies in their size and complexity. I’ll use the following [...]