Senators Kennedy, Hatch, Clinton, and Enzi announced legislation authorizing the FDA to approve a follow-on version of biologic therapies. The legislation, the Biologics Price Competition and Innovation Act of 2007, includes standards for the FDA to approve follow-on biologics as well as a period of exclusivity for the brand name drug company. The draft compromise […]
As a follow-up on yesterday’s article on the road to biogenerics, Food and Drug Administration deputy commissioner Janet Woodcock testified before an Oversight Committee held to examine the prospects and need for a pathway that would allow the FDA to approve safe and affordable generic versions of biotech drugs. Witnesses included representatives of FDA, pharmaceutical […]
Dr. Andrew von Eschenbach, the head of the Food and Drug Administration, addressed the issue of biogenerics at the annual meeting of the annual meeting of the Pharmaceutical Research and Manufacturers of America (PhRMA). Eschenbach basically outlined that biogenerics would be considered only “similar” to brand-name drugs, not interchangeable or able to be substituted. This […]
On March 8, a Senate committee will hold initial hearings on legislation that would establish a process for the U.S. Food and Drug Administration to approve biogenerics (generic versions of biologic drugs known as biosimilars). On average, the FDA approves one new generic version of a conventional (small molecule-type) drug per day but it lacks […]
Representatives Waxman, Emerson, and Pallone, along with Senators Schumer and Clinton, have re-introduced H.R. 1038, the “Access to Life-Saving Medicine Act,” which will establish a process through which the FDA will be able to approve generic biologics or biopharmaceuticals. While generic drugs have been extremely successful in bringing down the high cost of prescription drugs, […]
Legislators are stepping up the pressure in the long running saga of getting generic versions of biotech drugs to market. The FDA approves generic versions of pharmaceutical (small molecule) drugs once the patents for brand-name products expire. But complex biotech drugs do not have such an approval process. Representative Henry Waxman and Senator Orrin Hatch […]
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Editor-in-Chief Barista Stephen Jenei is a patent attorney and Owner of Jenei LLC. When not serving up patent chat over a steaming cup of java, he's handling a diverse intellectual property practice in the biotechnology, pharmaceutical and chemical fields. More info @ Jenei LLC
