Drug Topics - March 31, 2008 - (Page 4) 4 DRUG TOPICS MARCH 31, 2008 www.drugtopics.com Of Interest to Pharmacists GPhA: Tackling key issues of the day Fred Gebhart he 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. Look for the Generic Pharmaceutical Association to push even harder in the future. Speaking at GPhA’s annual meeting in Boca Raton, Fla., in February, association president and CEO Kathleen Jaeger complained that as recently as 2005, brand-name drug reps met with the Food & Drug Administration nearly 2,200 times compared with just 10 meetings with the generic industry. The actual numbers may have been a surprise. But Jaeger’s criticism echoes comments from inside and outside the Biogenerics and patent reform are two generic drug industry. key issues facing the generic industry, say Doug Long and Elaine Blais. “GPhA needs to be just as active and just as aggressive as PhRMA (Pharmaceutical Research and Manufacturers of America) if they expect to be as effective as the brand-name industry at getting their message across,” said Mary Anne Crandall, senior analyst and specialty pharmaceutical specialist at market research firm Kalorama Information, Kensington, Md. Here’s a look at where the association is focusing its current efforts. T 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 http://www.drugtopics.com
Table of Contents Feed for the Digital Edition of Drug Topics - March 31, 2008 Drug Topics - March 31, 2008 Contents NCPDP Eyeing Standards for e-MARs for Nursing Home Patients GPhA: Tackling Key Issues of the Day New Products Latest News Roundup Drug Topics - March 31, 2008 Drug Topics - March 31, 2008 - Contents (Page 1) Drug Topics - March 31, 2008 - Contents (Page 2) Drug Topics - March 31, 2008 - NCPDP Eyeing Standards for e-MARs for Nursing Home Patients (Page 3) Drug Topics - March 31, 2008 - GPhA: Tackling Key Issues of the Day (Page 4) Drug Topics - March 31, 2008 - GPhA: Tackling Key Issues of the Day (Page 5) Drug Topics - March 31, 2008 - New Products (Page 6) Drug Topics - March 31, 2008 - Latest News Roundup (Page 7)
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