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From Vol. 19, No. 44, November 1, 2013 BIO Disagrees With Lawmakers, Says ACA Left Biosimilar Naming To FDA

The innovator biologics industry disagrees with a bipartisan group of senators’ view that FDA would violate congressional intent if it were to decide biosimilars can’t share the same name as their reference products, arguing that the health care law left biosimilar naming decisions up to FDA’s discretion. The issue has been hotly debated among stake- holders in the weeks leading up to a recent World Health Organization meeting where one attendee said WHO signaled it would adopt a position.

The innovator and generic drug industries have voiced differing views on whether biosimilars should share an International Nonproprietary Name with the reference product or have a different identifier, possibly including a prefix or suffix. Last week a bipartisan group of six senators weighed in on the side of generics, writing to FDA that the agency would violate congressional intent were it to decide that biosimilars cannot share the same name as their reference product.

The lawmakers said requiring different names would raise safety and economic concerns, and pointed out that lawmakers rejected a statutory requirement that biosimilars be given unique names when they debated the Affordable Care Act. Lawmakers signing onto the letter included: Sens. Tom Harkin (D-IA), who chairs the Senate health committee, Jay Rockefeller (D-WV), John McCain (R-AZ), Bill Nelson (D-FL), Charles Schumer (D-NY) and Ron Wyden (D-OR).

The Biotechnology Industry Organization on Monday (Oct. 28) countered the lawmakers’ argument, saying Congress left naming decisions in the hands of FDA experts.

“Congress left it to the experts at FDA to make the decision about product names – as the agency does for every other product,” BIO said, responding to the lawmakers’ letter. “Reserving this to FDA will allow for thorough consider- ation of technical, scientific and patient safety issues involved. Minor differences between innovator and biosimilar products could lead to real differences for patients, therefore it would be inappropriate to permit use of the same nonpro- prietary name for biological products that are not the same from a regulatory or scientific perspective.”

Michael Reilly, executive director of the Alliance for Safe Biologic Medicines, agreed, saying the section of the Affordable Care Act that created the biosimilar pathway was written broadly to give FDA discretion. Further, he said the lawmakers’ letter relies on access issues to make the argument in favor of shared names, therefore it “does not hit at the heart of what FDA’s job is,” he said.

“We’re a long way from that letter turning into anything that could interfere with the FDA,” he said.

ASBM was among the stakeholders that testified during the WHO’s 57th Consultation on International Nonproprietary Names for Pharmaceutical Substances in Geneva, Switzerland last week. At the meeting, the Generic Pharmaceutical Association pressed for biosimilars to have the same INN as the reference product. Meanwhile ABSM, whose representa- tion includes patient groups, professional organizations and drug companies, asserted that unique names are necessary to track any safety problems that arise.

Reilly said he got a sense during the meeting’s open session that WHO will act — possibly before the next consulta- tion in April.

“The chairman (of the INN expert group) kind of concluded by saying, ‘We have our work to do,'” he said. Reilly noted the chairman also conveyed that not everyone would be happy with the outcome, although there is awareness of where everyone agrees and disagrees.

The issue has stirred debate among the innovator and generic drug industries, patient advocates and pharmacists. Three pharmacy groups last week reiterated their view that National Drug Codes are an alternative way to identify specific products, and said assigning unique names could interfere with pharmacy safety systems and complicate the collection of global safety information.

The National Kidney Foundation this week weighed into the debate on the side of innovators.

In a letter to FDA, the group states: “Tracking through NDC codes will not capture all cases because payers do not universally use NDC codes and these codes are not necessarily found in patient records,” according to the foundation’s Monday (Oct. 28) letter. “We recognize that the FDA is working diligently on an approval pathway that will ensure that biosimilars are both safe and effective, but our concern is that since biosimilars are produced without access to the innovator’s proprietary manufacturing processes, differences in composition compared to the original innovator product are likely to occur even for those considered interchangeable. While these changes may be minute, we know that individual patients can respond differently to even seemingly insignificant changes in drug formulation, manufacturing process, packaging, storage, or handling.”

Kerry Willis, the foundation’s senior vice president of scientific activities, said the group’s letter was a reminder to the agency of where the foundation stands. She pointed to previous safety issues that emerged soon after biologics launched or because of manufacturing changes as reason for being able to quickly find the source of adverse events.

In terms of patient access to lower cost medications, she said doctors will likely continue prescribing the lower cost options, even if this requires looking up names. “I think that doctors are aware of the cost issues,” she said. — Alaina Busch

Copyright 2013 Inside Washington Publishers. Reprinted with permission.

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