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Stephen M. Berberich

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Regulating biosimilar drugs comes to head in Congress
By Stephen M. Berberich   
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Last edited: Monday, July 25, 2011
Posted: Monday, July 25, 2011

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At issue are patents, profits and patient safety

The perennially and hotly lobbied issue on Capitol Hill of regulating generic versions of biotech drugs will finally end this year with a law, say sources in both the biotech and generic drug industries, bitter foes on the topic for years.

Regulating biosimilars or follow-on biologics, as they are also called, is more complicated than regulations from the 1980s regarding generic versions of small-molecule, or chemical, drugs. That is because biotech drugs, known as biologics, are complex, large-molecule vaccines, antibodies and other products made from living cells. Consequently, they are also among the most expensive medicines on the market.

While chemical drugs can be copied exactly into generic versions, biologics cannot. But generic manufacturers, such as Teva Pharmaceuticals of Israel, parent of Rockville's Cogenesys Inc., worry that without a shortened process to make biosimilars, the new generics will be as expensive as the originals — and of little marketable value.

The tipping point this year is the Obama administration's push to rein in health care costs, for better or worse, say Maryland's life science executives.

Hearings will soon be scheduled on two very different bills introduced this month by Reps. Henry A. Waxman and Anna G. Eshoo, (both D-Calif.). Each would give the Food and Drug Administration authority to approve biosimilars. An aide to Waxman said there is more buzz this year to "get it done" because, unlike last year, both bills were introduced with bipartisan support.

As in prior years, the main difference in these bills is how much time an originating biotech, called a brand company, will be allowed "exclusivity" protection of its product. The Waxman bill would protect the brand product for five years and the Eshoo proposal would protect the product for up to 14 years.

The Generic Pharmaceutical Association favors the Waxman bill with abbreviated exclusivity. Kathleen Jaeger, president and CEO, said in a March 17 statement, "The bipartisan consensus bill … achieves the balance of fostering pharmaceutical innovation while also making affordable medicines available to consumers."

The renewed regulation efforts come as the public is more accepting of generic drugs, according to a new Harris Interactive poll, which finds that over the past two years, the percentage of Americans who would choose generics over brand names has increased from 68 percent to 81 percent.

Not surprisingly, most, but not all, Maryland biotech leaders favor the Eshoo bill.

"Why bother to invent something if there is no exclusivity?" asked Richard A. Zakour, executive director of the MdBio Division of the Tech Council of Maryland.

At stake: Billions in revenues

The difference in these bills could mean billions of dollars for biotech companies, according to MdBio. Take MedImmune in Gaithersburg: Before Maryland's leading biotech was sold to pharma giant AstraZeneca in 2007, its sales of Synagis, a biologic for childhood lung infections, had grown to more than $1 billion a year.

Small Maryland biotechs such as Novavax, Rexahn Pharmaceuticals and MacroGenics may be more threatened financially by short-lived exclusivity.

"For all biotech, financing risks are very high and we are very realistic now," said Rahul Singhvi, president and CEO of Novavax, who some analysts say brought the company back from the brink of extinction a few years ago by consolidating it in Gaithersburg. Now, with an innovative vaccine pilot plant completed in Gaithersburg and a 318-patient, phase 2 clinical trial for its patented seasonal flu vaccine showing good results, Singhvi wants guaranteed protection in the marketplace.

"We are more in favor of exclusivity and we have biologics that are very complicated and it is very difficult to characterize them," Singhvi said.

"We are in the business of first-in-class products that will need market protection," said Chang H. Ahn, CEO and founder of Rexahn of Rockville. Rexahn has entered midclinical trials with patented treatments for cancer, neurological disorders and "all three phases of sexual dysfunction."

James Karrels, vice president and CFO at MacroGenics in Rockville, wants not only long-term exclusivity for its eventual biologics, including new antibody-based treatments, but some new human trials by any company making biosimilars of his company's biologics.

The biotech industry's trade group is pushing for rigorous testing of biosimilars before they are approved for market.

"We believe that clinical trials is the only way to determine if there is an immunogenicity problem with an adverse reaction" to a biosimilar candidate, said Sandi Dennis, deputy general counsel for health care at the Biotechnology Industry Organization.

"We understand, appreciate and support a pathway for biosimilars. It is good thing for the health care industry," said Jonathan Klein-Evans, MedImmune's vice president and deputy general counsel. "But there are concerns that we have in the field of biologics primarily around patient safety that a product produced by another company may have safety issues."

MedImmune supports the Eshoo bill, as does the 1,100-member BIO.

"We can take no shortcuts to safety when it comes to biosimilars," said James Greenwood, executive director of BIO, in a March 10 statement slamming the Waxman bill.

BIO's statements about patient safety "are thrown out there artificially as red herrings," said Lawrence Tamarkin, CEO of CytImmune Sciences, a small biotech in Rockville. "On the biosimilars issue, we are on the other side."

Biologic patents running only about seven years would create more opportunities in the marketplace for new technologies, Tamarkin said. CytImmune's patented nanotech strategy is leading to drugs to harness therapeutic potential of anti-cancer agents in the body, such as monoclonal antibodies, and tumor necrosis factor, or TNF, a tool of the immune system.

One of CytImmune's problems is that biotech giant Genentech of South San Francisco, Calif., controls the only line of TNF approved by the FDA for research, Tamarkin said, while other TNF lines are all equivalent.

"If we passed a biosimilar bill, we could use other cell lines," he said. "It would be significant because we would have the ability to negotiate with other companies and lower the cost."

Marcus Hunkeler also wants more liberal regulation of biosimilars. The senior director of marketing for BioReliance Corp., an industry fixture in Rockville, sees biosimilar regulation as good for both the biotech industry and patient safety. BioReliance does not produce biologics, but provides contract biologics safety testing.

"From the pure business perspective, we see it as a positive thing," Hunkeler said. "There is a lot more involved in generic biologics than [in] small-molecule drugs. There is definitely more things you have to be concerned about — that you are not purifying away residuals material from the [living tissue] used to grow up the biological. Therefore, no two biologics would ever be absolutely identical, leading to potentially more testing and more companies in the field."

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