Waxman asks Obama to look for alternative pathway for biosimilars

NEW YORK Support for a regulatory pathway for biosimilars has grown rapidly, and even a few branded companies, such as Merck & Co. and Pfizer, have expressed interest. But Rep. Henry Waxman's, D-Calif., request that the Obama administration look for legal means to let the FDA approve biosimilars before his bill, its companion in the Senate or fellow California Democratic Rep. Anna Eshoo’s competing bill is put to a vote, is a strong signal that biogenerics are going to be a reality in American health care — and sooner rather than later.

The Federal Trade Commission released a report Wednesday concluding that giving the Food and Drug Administration authority to approve biosimilars would be an efficient way to get them to market and lower consumers’ healthcare costs.

Immediately, the Generic Pharmaceutical Association praised the report, while the Biotechnology Industry Organization criticized it, particularly over the assertion that allowing market exclusivity periods of 12 to 14 years would be “too long to promote innovation.”

But the report also drew applause from CVS Caremark, whose EVP specialty pharmacy services, Dave Golding, participated in an FTC roundtable event on the issue last fall. CVS’ support is significant because of its stake – through its Caremark Pharmacy Services division – in the growing specialty pharmacy industry, which relies heavily on biotech drugs. In its 2009 Drug Trend report, pharmacy benefit manager Medco, which operates a significant specialty pharmacy business of its own, noted that a pathway for biosimilars could generate “a significant new wave of cost savings opportunities.”