FDA calling for hearing on biosimilars legislation Print E-mail
By Staff and Wire Reports   
Tuesday, 21 September 2010 09:09

The Food and Drug Administration will hold a two-day public hearing as it prepares to put into place regulations for the approval of generic versions of biological products.

This according to a report from The Hill, a print and on-line publication that aims to deliver non-partisan and objective reporting on the business of Washington, covering the inner-workings of Congress, as well as the nexus between politics and business.

Healthcare lobbyists are circulating a draft document which was obtained by the publication, but an FDA spokeswoman has refused to comment on the draft.

The healthcare reform law allows for the approval of generic versions of biologics — also known as biosimilars — after 12 years of patent exclusivity.  Biosimilars or follow-on biologics are essentially generic versions of biologic drugs. Essentially, biologics are genetically engineered proteins derived from genes(human, animal, micro-organism) and involve some type of biological process to produce the medicinal product. As you can tell, these are incredibly complex-drug process, which are vastly different from creating copycat versions of typical drugs that usually only involve chemical processes.

The two-day hearing would take place on Nov. 2 and 3. Since it's a draft the document could change before publication in the Federal Register, but it provides insight into the issues on which the FDA is seeking comment from industry.

Somewhat hidden in the healthcare reform legislation that passed this spring was a tax credit and exclusivity extension for biologic drug developers, which, according to healthcare market research publisher Kalorama Information, may have a long-term impact on the market for cancer treatments.

"The public debate about healthcare reform concentrated on who would be covered and how it would be paid for, but from our viewpoint the encouragement of biologic treatments is also significant," said Bruce Carlson, Publisher of Kalorama Information. "Had these provisions been passed alone, it would have been the big healthcare story of the year."

The Therapeutic Discovery Project Credit, enacted as part of the US healthcare reform, permits half of the development costs for a biological drug to be earned back in the form of a tax credit. The law is designed to skip over large pharmaceutical giants by limiting the tax credit to firms with 250 employees, but the entire industry could benefit from the second provision: twelve years of market exclusivity after FDA approval, allowing biotech drug developers the opportunity to build profits for new medications before low-cost generic equivalents are introduced.

"The law reduces the risk and increases the reward," said Carlson. "Small companies get half the research and development money back in their pocket, and if they do create a successful treatment they have a longer period to profit from it. It's a clear signal from the government that they want to see more of these new treatments."

The law is limited, as it provides for only a one billion-dollar pool of money for the next two tax years and when the pool is used up, no further credits will be granted. Firms must apply for the credit and qualify. Still, Kalorama believes there is enough money in the pool to encourage investment, especially in the treatment of cancer where there have already been successful biologic products.




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