While U.S. lawmakers jawbone [1] about a regulatory pathway for biosimilars, or biogenerics, Canada has moved to do it. Health Canada has posted draft guidelines for its regulatory approach to biosimilars. Manufacturers would have to show their products were similar to an existing biologic with interchangeability and substitutability decided on a case-by-case basis. New guidances are being drafted for various product classes.
In the U.S., meanwhile, there have been growing signs that any new legislation on biosimilars could be delayed past the current election year. But in Europe, regulators are busily approving a new slate of follow-on therapeutics.
- check out the report [2] from FDA News
- read the article [3] on the EMEA's approvals in Motley Fool
Related Articles:
Debate over follow-ons focus on market exclusivity. Report [1]
Budget has mandate for biogeneric approvals. Report [4]
Insulin debate spurs push for generic biologics. Report [5]
Waiting game continues for biogenerics. Report [6]
Links:
[1] http://www.fiercebiotech.com/story/debate-over-follow-ons-focus-on-market-exclusivity/2008-03-03
[2] http://fdanews.com/newsletter/article?issueId=11425&articleId=105152
[3] http://www.fool.com/investing/high-growth/2008/02/25/look-across-the-pond-for-biosimilars.aspx
[4] http://www.fiercebiotech.com/story/budget-has-mandate-for-biogeneric-approvals/2008-02-05?utm_medium=nl&utm_source=link
[5] http://www.fiercebiotech.com/story/insulin-debate-spurs-push-for-generic-biologics/2007-01-11
[6] http://www.fiercebiotech.com/story/waiting-game-continues-biogenerics/2007-09-10