Disagreements slow progress on biogenerics legislation

Washington -- Legislation creating an approval process for generic biopharmaceuticals could save billions of dollars in the next decade, but a crowded congressional agenda and a lack of consensus among lawmakers may prevent passage of a bill this year.

Members of Congress have introduced several measures to allow generic versions of biologic drugs, which are made with living organisms or materials. Examples include insulin and human growth hormone. The legislation differs on exclusivity -- how many years the Food and Drug Administration must wait before allowing a generic version. The bills also vary on the number and stringency of requirements that must be satisfied before generic biologics could be approved and labeled as interchangeable, meaning the generic version could be substituted for the original without physician approval.

One measure, approved by the Senate Health, Education, Labor and Pensions Committee in 2007, would save an estimated $25.2 billion in biologic drug spending over 10 years, found a Congressional Budget Office estimate released in June. The bipartisan Biologics Price Competition and Innovation Act of 2007 would provide 12 years of exclusivity and allow interchangeability once certain requirements were met.

The approval process for generic chemical drugs was created in 1984 with the Hatch-Waxman Act. It gives companies five years of exclusivity for new drugs and three additional years for new generations of products.

It does not, however, have a clear system to approve generic biopharmaceuticals.

Senate bill co-sponsor Orrin Hatch (R, Utah) said biologics are the future of medicine and that now is the time to create a pathway for generics. "The savings outlined in the CBO cost estimate underscore the absolute need to pass [the measure]. It is essential that Congress consider this important legislation before adjourning for the year."

Industries butt heads

The Biotechnology Industry Organization and the Generic Pharmaceutical Assn. have divergent views on the Senate measure and prefer other bills. BIO says 14 years of exclusivity is necessary to maintain incentives to develop new drugs.

Jim Greenwood, BIO president and CEO, cited a 2007 study by Duke University economist Henry Grabowski, PhD, which estimated that biologic manufacturers need 12.9 to 16.2 years to recover the average cost of research and development necessary to bring a drug to market.

Even the Senate bill's straight 12 years of exclusivity could significantly reduce the incentive to develop new biologics, Greenwood said. In contrast, an extra two years of exclusivity probably would not drastically reduce the CBO's estimated $25.2 billion savings for the Senate bill, he said.

BIO has endorsed the Pathway for Biosimilars Act, sponsored by Reps. Anna Eshoo (D, Calif.) and Joe Barton (R, Texas), the lead Republican on the House Energy and Commerce Committee. The measure, introduced in March, would provide 12 years of exclusivity, with a two-year extension available if there is a newly approved use for the biologic and six more months if the Dept. of Health and Human Services requests pediatric studies. The legislation also would allow interchangeability, but with a more stringent approval process than the Senate bill.

The Eshoo-Barton legislation has been endorsed by the Pharmaceutical Research and Manufacturers of America and the Assn. of American Universities.

The Generic Pharmaceutical Assn., however, is concerned that the bill would give brand-name drugmakers too much time to sell drugs exclusively. It objects to the requirement that public comments be solicited before a generic biological could be declared interchangeable. "Essentially it's legislation that's filled with roadblocks that will not get affordable biogenerics to patients," said GPhA spokeswoman Andrea Hofelich.

The GPhA also is concerned that the Senate bill would allow brand-name manufacturers to make slight adjustments to their biologics and receive an additional 12 years of protection. Greenwood countered that any additional exclusive period would require an original biologic maker to show significant improvements on the previous drug and would not prevent generic manufacturers from copying the earlier biologic.

The GPhA has endorsed the Access to Life-Saving Medicine Act, introduced by Rep. Henry Waxman (D, Calif.) in 2007. The bipartisan measure would allow generic biologics to be approved in an abbreviated process -- meaning without duplicating certain clinical trials -- the same way generic chemical drugs are approved. It would provide no exclusivity for brand-name biologic makers.

There's no reason to believe that framework for chemical drug generics wouldn't work for biogenerics, Hofelich said. Biologics don't take significantly longer to develop than chemical drugs, she said. The same 2007 study by economist Grabowski found that the average development time for a new biologic was 97.7 months, compared with 90.3 months for chemical drugs.

The American Medical Association has not taken a position on the bills. It is concerned about any measure's effect on patient safety, incentives for innovation and physicians' independence. Legislation should not compel doctors to treat biogenerics as interchangeable with brand-name biologics and should balance the need for market exclusivity with competition, according to the AMA.

The FDA should have the authority to require clinical trials for biogenerics and carry out post-market surveillance and adverse-event communication, according to the concerns expressed by AMA. Also, a bill should not give the agency the right to approve biogenerics that differ in efficacy and safety from the original drug.

Efforts are ongoing

Meanwhile, other House lawmakers continue to search for agreement on an approval pathway. In April, Reps. Frank Pallone Jr. (D, N.J.), chair of the House Energy & Commerce health subcommittee, and Nathan Deal (R, Ga.), the panel's top Republican, sent a list of 49 questions asking advice from 36 organizations about creating a pathway. Twenty-nine responded. Pallone continues to review the letters and is committed to building a consensus in the subcommittee, said his spokesman Andrew Souvall.

Also, the FDA continues to work on a proposal to seek new authority for an abbreviated approval process for certain generic biologics.

A tight election-year schedule is going to make it difficult to advance legislation, the GPhA's Hofelich said. The lack of consensus in the committees means it won't be easy to move a bill quickly, BIO's Greenwood said.

Aides to two members of the House Energy & Commerce Committee -- a key panel for generic biologic legislation -- agreed that time is running out but said there is a window in which members could advance a bill.