MCCLELLAN PREDICTS BIOGENERIC BILL APPROVAL, MULTIPLE REGULATIONS

A biogeneric approval mechanism may lead regulators to create separate rules for these types of treatments, according to former Centers for Medicare & Medicaid (CMS) Administrator Mark McClellan, who said he is optimistic that Congress will pass legislation this year easing the entry of follow-on biologics.

While McClellan's optimism echoed sentiments expressed by both Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.) at the Generic Pharmaceutical Association's annual conference, he said lawmakers should create a well-founded scientific pathway process prior to passing the bill, S.623, the "Access to Life-Saving Medicine Act."

"The biologic approval process could involve an array of individual regulations because of the complexities and differences in developing these products and bringing them to market," McClellan said at the conference.

Biologics span a wide range of complexities in "protein folding and potential impurities," McClellan pointed out, and if the bill is passed prior to the establishment of a pathway that addresses such areas of manufacturing, regulators will spend an enormous amount of time and drive up agency costs to craft the necessary regulations, McClellan said.

The absence of a clear, scientific pathway for approving biogenerics could result in patients experiencing adverse events, he added.

The FDA's approval of Sandoz's Omnitrope, the first biogeneric human growth hormone, may be the process on which to model a pathway to approve a relatively simpler biologic, according to McClellan.

"The more you can build broad policy acceptance, the greater chance of bringing an approval process to market faster," he said.

( http://www.fdanews.com/did/6_46/ )