Posts Tagged ‘FDA’

FDA Publishes “Purple Book” for Biologicals/Biosimilars

Thursday, September 11th, 2014

In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked here is the publication from BIO’s new Intellectual Property Newsletter that links to the FDA press release from the FDA Blog.

CDER List of Licensed Biological Products

CBER List of Licensed Biological Products

 

FDA’s New Biosimilars Guidance

Monday, August 11th, 2014

The following has been posted with the permission of their authors James E. Valentine and James C. Shehan of Hyman, Phelps & McNamara as part of their FDA Law Blog.

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August 09, 2014

FDA’s New Biosimilars Guidance Has Sponsors Provide Information to Win Reference Product Exclusivity; Liberal Criteria Opens the Door to More Exclusivities Being Awarded

By James E. Valentine* & James C. Shehan

On August 5, 2014, FDA announced the availability of its most recent biosimilars guidance entitled, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act” (“FDA Draft Guidance”). The Draft Guidance puts some sponsors of BLAs past, present, and future, on notice that FDA wants them to submit certain information for their biologics to be considered for “reference product exclusivity.”  But that’s a burden that sponsors will likely gladly bear, because FDA’s proposed broad interpretation of structural modification, a key term in determining whether a related product differs enough from a sponsor’s structurally related product to merit its own exclusivity, makes more products eligible for exclusivity than is required under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).

FDA Accepts First Biosimilar Application for Review

Monday, July 28th, 2014

In an important step forward for the introduction of “generic biological,” the FDA announced that it has accepted Sandoz’s application to market a generic version of Amgen’s Neupogen®, which stimulates white blood cell production. As you may recall, about two years ago, the FDA was authorized to permit generic biologicals in a section of “Obamacare” (the Affordable Care Act), but final rules have not yet been promulgated. Since Neupogen is not “under patent” or NCE exclusivity in the U.S. this can roughly be analogized to a Para. III ANDA filing. With many other applications in progress, we will have to see how rough this gets.

Read more here.

Biotech’s PR Problems Continue

Friday, February 15th, 2013

Maybe “Fish gotta swim” but the FDA has extended the approval period for transgenic Salmon genetically engineered to reach market weight sooner. No evidence at all has been presented that filets from these fish would present a danger human consumers – and may well provide a benefit to an increasingly hungry world.

This report once again reminded me how far scientific advances in biotech have exceeded the industry’s attempts to explain their benefits to the consuming public. As biotech companies wisely sold the advantages of herbicide resistant corn, cotton and soybeans to farmers well prior to their “launch”. Farmers were tired of using herbicides that could kill their human handlers. By the time the Supreme Court decided that plants were patentable (in 2002), about 65% of U.S. corn was transgenic (and patented as well). However, the EU countries don’t grow much corn, and the lack of lobbying there contributed to the general ban on imports of genetically engineered crops and sandwich shops that advertise that their snacks have no GMO’s.

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