Senate bill paves way for generic biologics

WASHINGTON -- The US Senate yesterday hammered out a long-awaited bill that paves the way for generic versions of the world's most expensive drugs, while providing a 12-year financial cushion for local biotechnology leaders who worry that such lower-priced drugs would hurt sales of their name-brand products.

Staffers for four key senators have met for weeks, finessing the details of legislation to give the Food and Drug Administration new powers to approve generic versions of biologics -- therapies based on living organisms .

Already, generics that are the chemical equivalents of name-brand drugs save patients and the federal government billions annually.

The compromise bill unveiled yesterday represents a delicate balancing act, said Senator Edward M. Kennedy , Democrat of Massachusetts .

It would speed generic biologic drugs to market by requiring fewer clinical trials before approval, while maintaining financial incentives for such biotechnology leaders as Cambridge's Genzyme Corp. and Biogen Idec Inc., which funnel revenue into development pipelines to produce more biologic treatments.

"Congress has a responsibility to encourage the innovation that leads to these new medical miracles, and to see that they are affordable for the patients who need them," Kennedy said in a statement. "Our bipartisan legislation also includes strong and responsible incentives to encourage dynamic new biotechnology companies to invest in the innovations that will produce the cures of tomorrow."

Among the most contentious issues was how long of a safe haven to give branded biologics before generics could compete for the same business.

Biotech companies wanted 14 years of market exclusivity. A letter signed by AARP and others said that "would unnecessarily" limit access to affordable drugs and "would actually have the perverse effect of reducing incentives to innovate." Generic manufacturers and their supporters said five years was sufficient.

In the end, the Senate opted for 12 years, as was strongly advocated by Senator Orrin Hatch , Republican of Utah . The bipartisan bill's other sponsors are senators Hillary Rodham Clinton , Democrat of New York , and Michael Enzi , Republican of Wyoming .

But generic manufacturers are still poised to save money on their development costs through a speedier path to market that leverages what the FDA already knows about the safety and effectiveness of the branded versions of biologics.

In some cases, the FDA could waive clinical trials in humans prior to approval, according to Kennedy's office.

Already, Novartis AG is poised to seize on the opportunity. The drug maker said yesterday that its generic version of a blood-building therapy drug Epoetin alfa is close to reaching the market in Europe . The anemia remedy is sold under the brand names Epogen and Procrit and accounts for such a staggering portion of federal pharmaceutical spending that congressional watchdogs have eyed their marketing and sales growth.

But generic manufacturers like Novartis would be subject to the same risk management plans contained in FDA reform legislation that passed the Senate and is pending in the House.

That legislation opens the door for generic manufacturers to conduct post marketing clinical trials after their products are made available for sale.

Another sticking point in the senators' deliberation was how pharmacists should handle prescriptions for the newest generics.

Now, for instance, pharmacists can fill a prescription for the cholesterol drug Zocor with the generic version without first consulting the physician. Pharmacists could one day do the same for generic biologics, under the compromise bill.

The generic manufacturer would have to prove its drug is similar to the name version and the FDA would have to vouch that it had sufficient evidence that the two products produce the same clinical result.

The Senate measure is scheduled to clear a key committee on Wednesday .

Diedtra Henderson can be reached at dhenderson@globe.com.