The Boston Globe weighs in with a lengthy look at the tussle over biogenerics--a.k.a. follow-ons and biosimilars. The smart money is betting that at some point in the not-too-distant future Congress will get around to giving the FDA authority to approve biogenerics on a case-by-case basis. But don't expect the biotech lobbyists to back off of this issue anytime soon. As a concession, BIO is seeking 14-year market exclusivity for biotech drugs to compensate developers for the time it takes to gain approvals for these complex therapies. And they may come close: Lawmakers including Massachusetts' Ted Kennedy are backing a 12-year period of exclusivity.
- read the article [1] in the Boston Globe
Related Articles:
Budget has mandate for biogeneric approvals. Report [2]
Waiting game continues for biogenerics. Report [3]
Dr. Reddy's make risky biogenerics move. Report [4]
Lawmakers propose pathway for approving biosimilars. Report [5]
Links:
[1] http://www.boston.com/business/healthcare/articles/2008/03/03/cost_control_plan_generics/?page=2
[2] http://www.fiercebiotech.com/story/budget-has-mandate-for-biogeneric-approvals/2008-02-05?utm_medium=nl&utm_source=link
[3] http://www.fiercebiotech.com/story/waiting-game-continues-biogenerics/2007-09-10
[4] http://www.fiercebiotech.com/node/7447
[5] http://www.fiercebiotech.com/story/lawmakers-propose-pathway-for-approving-biosimilars/2007-02-15