Senators Enquire on Policy for Biosimilars

Within a week of Sandoz applying for approval of it's biosimlar to Amgen's Neupogen, U.S. senators want the FDA to lay down guidelines on naming these drugs.

One week after the FDA received its first request to approve a biosimilar medicine, a handful of U.S. senators has asked the U.S. Department of Health and Human services when a formal policy will be adopted for naming these medications.

Their missive was sent just as the World Health Organization suggested a new proposal for naming biosimilars, which are designed to emulate brand-name biologics and are forecast to save billions of dollars in health care costs.

At issue is whether biosimilars should be given the same International Proprietary Name, or INN, as brand-name biologics. The WHO oversees the global INN system, but individual regulatory agencies in each country are not bound by the latest WHO proposal.

As we have noted previously, the naming debate is particularly contentious and has divided the pharmaceutical industry, which has been lobbying the FDA to chart a course. A central focus of the debate is whether different INNs would hamper substitution needed for lowering health care costs.

Original report:

Source: The Wall Street Journal