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 in the Boston Globe