WASHINGTON, DC—Rep. Henry Waxman (D-Calif) has been trying since March to get his bill allowing the FDA to approve generic versions of biological drugs (“biosimilars”) out of his own House Committee on Energy and Commerce. Having failed at that, and perhaps inspired by the Obama Administration's creative approaches to other parts of the economy, Rep. Waxman now wants the White House to allow the FDA to start approving generic biologics, even though the agency has no legal authority to do so.

On Monday, June 8, 2009, Mr. Waxman sent a letter to President Barack H. Obama that said in part, "I urge the administration to consider what steps can be taken under existing authority to prepare and even begin to use a pathway for generic biologics."

This is an unprecedented attempt to circumvent the patent rights of biotech and pharma companies who developed and brought to market the TNF inhibitors and other biologics now transforming areas such as arthritis and cancer care.

Biologics currently do not face generic competition in the US because Congress has been unable for nearly a decade to pass the legislation needed to give the FDA the power to approve biosimilars. Patent life has been a major sticking point. The biotech industry wants 14 years of exclusive marketing rights, in view of the expense and difficulty of developing and producing many of the drugs. Mr. Waxman's bill would give them only the 5 years that makers of conventional new drugs get. The Obama Administration's 2010 budget proposed 7 years of marketing exclusivity.

Biotechnology Industry Organization head Jim Greenwood said in a statement that the industry “continues to support strongly the development of a pathway for the review and approval of biosimilars...(but Waxman's bill) does not strike the necessary balance for patients or the economy."

A competing bill to Mr. Waxman's would allow 12 years of data exclusivity with provisions for an additional 2 years for a “medically-significant new indication” and 6 months for pediatric studies.

Mr. Waxman's suggestion that the government use "existing [FDA] authority" to justify a follow-on biologics pathway overlooks some important issues in the biosimilars debate. These include safety and efficacy, interchangeability, and the definition of a “biosimilar.” Unlike generic conventional drugs, which contain the same chemical entity as the original drug, “biosimilars” can have differences in primary amino acid sequence, post-translational modifications, level of impurities, the mechanism of action, and the mode of administration. The issue of interchangeability between original and follow-on drugs is particularly important in view the potential for unanticipated adverse effects.