Today’s Washington Post features a story on Ismed’s efforts to promote a follow-on biologics approval pathway here in Washington.  The article outlines the campaign by Insmed’s chief exec, Geoffrey Allan, to give Congress a lesson in biotechnology.

The sudden outpouring of educational efforts on protein structures and drug pharmacology has to do with the fact that Insmed is looking to be the first U.S. company to develop biotech generics — a/k/a follow-on biologics (FOB), sometimes called biosimilars or biogenerics.

The question is whether the FDA should approve generic biotech drugs the way generic small molecule pharmaceuticals are approved.  Unlike with small-molecule drugs, there’s no mechanism for generic-drug makers to gain approval for follow-on biologics.   For some companies, an approval process could be a matter of survival.

The Public Health Service Act, under which biologics are licensed, does not contain any type of shortcut or abbreviated approval pathway analogous to the process used under the Food, Drug, and Cosmetic Act for generic drug approvals, according to the FDA.  However, the agency has approved some follow-on biologics under the FD&C Act, such as GlucaGen, Hydase, Fortical and Omnitrope.

Under any new law, a follow-on biologic applicant will be required to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the brand product in order for the FDA to approve a follow-on biologic as interchangeable. However, the applicant must provide evidence that its product will produce the same clinical result as the brand product in any given patient and that it presents no additional safety risks or diminished efficacy if a patient alternates or is switched between products.  This will be a tough road to travel.

A recent Congressional Budget Office analysis found that biosimilar competition would reduce expenditures on biologics by about $200 million by 2013 and about $25 billion by 2018. With savings amounting to about 0.5 percent of national spending on prescription drugs over the next decade, why isn’t Congress all over this idea? The main problem is the length of data exclusivity, which can run during and longer than the period of patent protection.

Earlier, the Senate Health, Education, Labor and Pensions Committee passed the Biologics Price Competition and Innovation Act, S. 1695, which would have established a way for the FDA to approve products as biosimilar to existing biologics. As a compromise, S. 1695 would have granted 12 years of data exclusivity to innovator biologic drugs.  Congress abandoned its efforts to include follow-on legislation in the PDUFA bill and has said it will address biogenerics in a separate bill.

Insmed, along with consumer groups such as AARP and the National Organization for Rare Disorders, are lobbying for five years, the same length as chemical drug data exclusivity, while the Biotechnology Industry Organization supports a 14-year period.  Hence, the intense efforts to educate Congress on protein chemistry.

Amgen’s biologic drug Neupogen, which stimulates white blood cell growth, generated $1.3 billion in worldwide sales last year.  Insmed, who would like a peice of that marker, has now demonstrated that its biosimilar version of Neupogen was equivalent in 32 healthy volunteers to the original product. But, for now Insmed’s version will have to wait.

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  2. There is no need for a shortcut in the PHS Act..the law only requirement on FDA is that it licensure of a biolgics be based on critiera established by FDA as necessary to assure the safety, purity…of the product.

    There is a long history of FDA approving new biologics based on an essentially generic basis
    — blood and blood products
    — allergenic products meeting compendial standards
    –certain vaccines
    — ….

    The arguement that “biotech products” are too complicated falls apart when you consider that biologics/natural products/peptides under the FDC Act have been generics or 505b2, that there are a great many small molecular drugs that have narrow therapeutic index, complex delivery/bioavalibility and synthesis/identity issues (think warfarin, conjugated estrogens and heparin).

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