Sunday, March 02, 2008


US biotech companies and biosimilars

Gauri Kamath

The Biotechnology Industry Organization (BIO), a powerful Washington D.C. lobby of biotech companies, including Amgen and Genentech, has reportedly said that it will push for a legislation that allows the US drugs regulator to approve copies of their blockbuster drugs once they lose patent protection.

That does not currently happen even though copies of chemical drugs — known as generics — are routinely launched after a patent on the drug expires. For nearly a decade, BIO has stonewalled similar approvals for biotech drug copycats claiming that they need more elaborate tests than generics.

In the meantime, generics companies, including Indian pharma firms, that bet on this market opening up much earlier, have seen their plans go haywire.

Imminent regime change in Washington may have forced BIO to soften its stance. International reports suggest that all three US Presidential candidates think generics are effective in keeping spiralling healthcare costs under control and BIO might want to push a law that suits them under the current President. So far BIO has raised objections to provisions in bills that were written to create a separate pathway to approve biosimilars.

Companies like General Motors have cited employee healthcare costs as one reason for going into the red. The generics industry sees a huge market and is also a vocal supporter of biosimilars. About $10 billion worth of drugs are expected to lose patent protection by 2010 in the US.

BIO's earlier attitude of resisting biosimilars is revealed on their site:
Follow-on biologics are not generic drugs. A generic drug is a product that is shown to be the same as an innovative drug, and is generally designated as therapeutically interchangeable with the innovator drug. Unlike generic drugs, a follow-on biologic (or "biosimilar") is a product that is similar to, but not the same as, the innovator drug. Because of the complex science involved, the Food and Drug Administration (FDA) and foreign regulators have indicated that the generic drug approval pathway is not appropriate for complex biologics.

It is essential that Congress recognize and adopt the following key principles:

Ensure that approval of follow-on biologics is based on the same rigorous standards of safety, purity, and potency applied by FDA for the approval of pioneer biotechnology products.

Recognize Scientific Differences Between Drugs and Biologics. Biologics are much more complex than small molecule chemical drugs.

Maintain the Physician-Patient Relationship. Small molecule generic drugs can be designated as therapeutically equivalent and may be dispensed interchangeably with innovator products without physician knowledge. In contrast, the current state of science is not sufficient to establish interchangeability for complex follow-on biologics.

Preserve Incentives for Innovation. Include substantial non-patent data exclusivity, Respect intellectual property and other legal rights, Provide adequate notice and process rights

Curiously some parts of that site have been hacked! BIO has also been lobbying hard through politicians against biosimilars:

Urging caution on a bill that would permit marketing of cheaper generic versions of biologic therapies, Representative Thomas Davis III directed attention to an image on oversized television screens set around the hearing room -- a diagram of a massive protein looming over a tiny, much simpler protein.

Davis's message was as simple as the image was complicated: Generic biologics are too complex to approve without first conducting clinical trials.

The image may have been familiar to many of Davis's fellow lawmakers. The same slide is part of a PowerPoint presentation that James C. Greenwood , a former congressman now leading the Biotechnology Industry Organization , has been showing in his lobbying campaign.

Pharmaceutical , medical device and other health product companies plowed nearly $182 million into lobbying Congress from January 2005 through June 2006 , the Center for Public Integrity reported this month.

"I never saw a more powerful domestic economy lobby than the pharmaceutical lobby. They are pervasive. They've got so much money," said William Vaughan , a senior policy analyst at Consumers Union with 36 years of Hill experience.

Hatch and Representative Henry A. Waxman , Democrat of California , earlier co sponsored a bill that speeds to market generics that are chemical equivalents to branded products, saving consumers billions .

Hatch said that bill took a more balanced approach that rewarded innovation at the same time it lowered barriers for generics.

"Unless we can balance both sides, we are going to really hurt the development of the follow-on biologics," Hatch said.

PAC money is just part of what drives stiff opposition to the current legislation, Consumers Union's Vaughan said. Such members as Burr represent districts where pharmaceutical and biotechnology industries are major employers and others, such as Davis and Hatch , seek to ensure that the innovator industry makes enough profit and enjoys sufficient patent protections to keep those economic drivers located in the United States.

Another vocal opponent, Representative Darrell Issa , Republican of California , said that he's been approached by industry lobbyists and Amgen Inc. Analysts have already begun to pare revenue forecasts for the California-based biotech heavyweight's anemia remedies Aranesp and Epogen because the generic biologic bill is expected to pass earlier than anticipated.

Issa, like industry lobbyists, points to potential safety problems that could occur if generic biologics are released without first undergoing clinical trials. In future hearings, he said he intends to prod the FDA to prove it has the scientific expertise to handle the approvals.

"The stakes are very high," Issa said. "To pretend that we don't need clinical trials . . . flies in the face of common sense."

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