GPhA: Tackling key issues of the day

March 31, 2008

The Generic Pharmaceutical Association looks at biologics, citizen petitions, patent reform, trade policy, and other key issues.

The biggest potential driver for future growth in the generic industry is "the creation of a clinical pathway for biosimilars in the United States," said Doug Long, VP of IMS Health, Norwalk, Conn.

The actual numbers may have been a surprise. But Jaeger's criticism echoes comments from inside and outside the generic drug industry.

Pushing for biogenerics

How to handle the generic equivalents of biologics is so unsettled that basic terminology is still up in the air. Follow-on biologics, biogenerics, and biosimilars are all commonly used.

The European Medicines Agency (EMEA) has been approving what it calls biosimilars for several years. The FDA is still waiting for Congress to create a pathway for similar approvals in the United States.

PhRMA and the biotech drugmakers' own association, the Biotechnology Industry Organization (BIO), have long opposed biogenerics, noted GPhA spokeswoman Andrea Hofelich. The argument against biogenerics has focused on warnings about the scientific and technical difficulties of creating and testing new biologic agents.

GPhA has been pushing for a biogeneric approval pathway from its inception. A growing number of groups have joined the call for biogenerics, prompted by growing sophistication of biotech production technology and the increasing costs of biotech products.

A common example is Avastin (bevacizumab, Genentech), an anti-angiogenic protein used to treat a variety of cancers. Treatment costs about $50,000 per patient per year.

The Coalition for a Competitive Pharmaceutical Market (CCPM), a group of 30-some employers, insurers, health maintenance organizations, generic drugmakers, GPhA, pharmacy benefit managers, and others, estimated that biogenerics could save $14 billion over 10 years in the Medicare Part B program alone.

CCPM backed bipartisan biogeneric legislation introduced in Congress in 2007. Likely Republican presidential nominee Sen. John McCain (R, Ariz.) is a strong supporter of generics. So are both Democratic contenders, Sens. Hillary Clinton (D, N.Y.) and Barrack Obama (D, Ill.).

Earlier this year, biogeneric opponents started talking about the need for a clear approval pathway. "We've made good progress in having this issue understood by the people who are in place on Capitol Hill now," said BIO president Jim Greenwood. "We'd like to get it done this year so we don't have to start all over again."

GPhA would like to see a biogeneric pathway approved this year, too. But GPhA and BIO have different ideas on how that pathway would work.

Rep. Anna Eshoo (D, Calif.) is reportedly drafting legislation that would give originators between 12 and 14.5 years of market exclusivity. A draft of the bill would also require biogeneric applicants to pay the same user fees paid by reference product sponsors, restrict declaratory judgments for biogeneric applicants, require clinical studies to support biogeneric applications, and lower the bar for legal challenges to biogeneric applications.

In return, the first approved biogeneric maker for each reference product would get 24 months of market exclusivity. "Pretty much every barrier you can think of is built into that legislation," Hofelich said. "BIO and PhRMA are saying that biogenerics should far exceed the statutory requirements for their own products."

Hofelich said GPhA would prefer to see a biogeneric pathway approved in 2008. But without significant changes to current proposals, the association is willing to wait for a new political climate in 2009.