FTC Holds Roundtable On Follow-On Biologics
4 CommentsBy Ed Silverman // November 21st, 2008 // 7:22 am
This topic may have fallen off the radar screen amid the presidential election and the recession, but the rising cost of biologics continues to be a problem. And the Federal Trade Commission wants to shape the discussion before Congress and the FDA proceed with a framework that will permit drugmakers to create and market lower-cost versions.
So, at 8:30 am EST today, the FTC will conduct a workshop organized into five panels to discuss the following issues: the price and market share effect of entry by both biosimilar and biogeneric drugs, the likely competitive effects of reference product regulatory exclusivity, biotechnology patent issues, the likely competitive effects of follow-on biologic regulatory incentives, and the patent resolution process.
The FTC, you may recall, wrote a letter in May to the House Energy & Commerce Committee, saying Congress “should limit companies’ ability to game…exclusivities at the expense of consumers by (1) disconnecting the FDA approval process for generic biologics from patent litigation, and (2) ensuring there is no opportunity for brands effectively to lengthen their exclusivities through insignificant changes to a branded biologic product or through excessive procedural delays.”
Panelists will include luminaries from the FDA, BIO, insurers, generic and brand-name drugmakers, academia and patent lawyers. This is the agenda, and these are the public comments filed with the FDA by various companies and groups over the past several weeks. The roundtable, by the way, will be webcast (go here to tune in).
B Billings
It’s mind boggling that generic versions of biologic medicines are approved and available to patients in 11 countries outside the U.S. but not here at home. Why? Because for some reason we failed to have the foresight to give FDA a regulatory process to approve these products. Meanwhile, with no competition from generics, prices for brand biologic drugs continue to skyrocket. Hopefully now, with support from the new President and the FTC, we can catch up with the rest of the world and begin providing safe, effective and less-expensive versions of these critical medicines.
parson
Excellent. The destruction of the specialty pharma and biotech sectors is almost complete.
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Stinky
This wouldn’t lead to a destruction, the margins would still be largely intact, unlike small molecule pharma. Should biotechs get an infinite patent life, and be able to charge upwards of $100k/year for certain specialty products for eternity? I think not, there is more than enough money at lower margins for their business models to be comfortably sustainable.
Stinky
Stinky
Ed,
Any scoop on what was discussed at the meeting?