[Ip-health] Boston Globe: Senate Bill Paves Way for Generic Biologics

[Mike Palmedo]

http://www.boston.com/business/healthcare/articles/2007/06/23/senate_bill_paves_way_for_generic_biologics/

Senate bill paves way for generic biologics - Compromise aims to speed
approval, allay drug makers' fears

By Diedtra Henderson
Boston Globe
June 23, 2007

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 Zoo 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.

--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu