Compromise legislation that would create a pathway for FDA approval of follow-on biologic drugs -- sometimes misleadingly referred to as generic biologics -- passed its first test on June 27th when a U.S. Senate committee approved the measure on a voice vote.

The compromise hammered out by key Senators addressed such issues as the extent of trials a follow-on biologic would need prior to approval, whether a biosimilar could be deemed interchangeable with a brandname biologic, and the length of time an innovator biologic would be protected from competition.

"The bill reflects a balanced approach that enables patients to have safe, effective and affordable biological drugs, while preserving the incentives that have brought these life-saving advances to the American public," said Sen. Edward M. Kennedy, chairman of the Health, Education, Labor and Pensions Committee.

What will happen next, however, remained far from clear. The House of Representatives has yet to consider two widely differing approaches to follow-on biologics, and even if the House acts, it is far from clear that Kennedy will succeed in adding follow-on biologics provisions to a major FDA funding bill.

Predictably, the biotech industry and the manufacturers of generic pharmaceuticals took differing views of the compromise legislation.

The generics industry particularly objected to a compromise that provided biopharmaceutical companies which invest heavily in developing new biologics a guarantee of 12 years of exclusivity before a follow-on version could be brought to market.

"Such an arbitrary and excessive period of time is not only unprecedented and unwarranted, but more importantly, would unjustifiably delay access to affordable competition and choice," Kathleen Jaeger, president of the Generic Pharmaceutical Association, said in a statement.

The Biotechnology Industry Organization, on the other hand, objected to a compromise provision that allows for the possibility of "interchangeability," meaning some biosimilars could potentially be automatically substituted for the original branded medicine.

“Biologics are large, complex organisms, derived from living cells. Even small changes can render the biologics ineffective or even potentially harmful,” said BIO president Jim Greenwood. “To protect patient safety, Congress should ensure that patients are not given follow-on biologics unless expressly prescribed by a physician.”

The full Biotechnology Industry Organization statement on the legislation can be viewed by clicking here.

The full Generic Pharmaceutical Association statement on the legislation can be viewed by clicking here.