Coalition for Safe and Innovative Medicine

October 07, 2009
Law360
Bruce S. Manheim and Denise L. Loring

Intellectual property protection may not immediately come to mind when one considers health care reform, but it should.

Those interested in patent protection should pay special attention to provisions in this pending legislation that would authorize the Food and Drug Administration to approve follow-on versions of biotech medical products (“biosimilars”).[1]

These provisions would establish a complex dispute resolution scheme for biotech medicine patents that departs significantly from the rules of civil litigation.

If enacted, the legislation threatens to convert the U.S. patent system into a two-tiered regime in which biotech medicine patent holders would have fewer rights to enforce their patents. This could diminish the value of biotech patents.

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September 25, 2009
Connecticut Record Journal
By Jim Greenwood

For too long, the health care debate has focused on issues that divide the political parties, undermining meaningful reform. Many lawmakers have, however, been able to find common ground on one issue in this massive debate: the approval of biosimilars. Biosimilars, often erroneously referred to as biogenerics, are medicines that are similar to, but not the same as breakthrough biologic medicines.

Biologics represent the cutting edge of medicine, providing advanced therapies and drugs that are saving and extending the lives of patients living with debilitating diseases including cancer, Multiple Sclerosis and HIV/AIDS. Continued advancements hold the promise of improved medicines and, one day, cures. By allowing biosimilars to enter the marketplace, Congress can increase patient access to life-saving medicines, reduce costs and provide a foundation for continued biomedical innovation.

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September 20, 2009
Patent Docs
By Donald Zuhn

Earlier this month, James Love and James Glassman, writing in the Congressional newspaper Roll Call, expressed “alarm” regarding recent Congressional action concerning the establishment of a follow-in biologics (FOB) regulatory pathway (”Don’t Kill Competition for High-Tech Drugs”).  That action included the recent passage by the House Committee on Energy and Commerce of a health care reform bill containing a licensure pathway for biosimilar biological products that would prevent the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed (see “House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period”), and prior approval by the Senate Health, Education, Labor and Pensions (HELP) Committee of an amendment providing a 12-year data exclusivity period for biologic drug makers (see “Senators Champion 12-Year Data Exclusivity in Senate”).

 James Love, the director of the public interest advocacy group Knowledge Ecology International, and James Glassman the former under secretary of State for public diplomacy and public affairs in the George W. Bush administration and editor of Roll Call from 1988-93, contend that passage of FOB provisions by the House Energy and Commerce and Senate HELP Committees would “make it difficult, if not impossible, for generic drugs to compete with biologics, even after patents have expired.”  The authors add that these provisions, if reconciled and passed into law, have “the potential to harm millions of sick people, in the United States and beyond.”

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September 21, 2009
The Hill
By Francis B. Palumbo

President Barack Obama is keenly interested in holding down the cost of healthcare while increasing access for tens of millions of Americans and has strongly advocated for a public option. And while Congress is consumed with debating this major change in our healthcare system, it is also debating another controversial issue, also intended to improve access and contain costs — the issue of “follow-on biologics” or “biosimilars.”

These are injected biologicals used to treat many truly dreaded diseases such as cancer and multiple sclerosis, as well as other serious illnesses. They are made from organic sources such as animal cells, microorganisms and yeast, and have given new hope and new life to many people with crippling illness.

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October 8, 2009
Seattle Post-Intelligencer
By Jim Greenwood

Washington state has long been a home for innovative thinkers. From Boeing to Microsoft to Amazon.com, companies based in Washington have pushed the envelope on what’s possible. Senator Patty Murray (D, WA) and Representative Jay Inslee (D, WA-1) have followed suit with their leadership on legislation that would enable biotech companies in Washington and across the nation to continue their quest for innovative cures and therapies to address unmet medical needs.

The most promising medical innovations are coming from biotechnology companies in Washington and across the United States. Among the most advanced innovations are biologics – complex proteins produced by living cells that have been custom designed using our newly acquired understanding of human genetics and DNA. Biologics have added major therapeutic options for the treatment of debilitating diseases (such as cancer, HIV/AIDS, Alzheimer’s, multiple sclerosis and many rare diseases) including some for which no effective therapies were available and others for which previously existing therapies were clearly inadequate.

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March 8, 2009
The Boston Globe

FOR DECADES, patients have benefited from the lower prices of generic drugs after name-brand patents have expired. Now, government officials want to do the same for a new type of drugs called biologics, which are based on living cells.

But the biotech companies that devise and produce these complex new drugs are at odds with the generic manufacturers that want to get into the market. The dispute is so deep that biotech officials refuse to call the copycats “generics” or “biogenerics,” since those terms carry a suggestion of duplication. Biotech prefers to call them “follow-on” drugs or “biosimilars.” The two sides are so deeply divided that Congress has not been able to legislate ground rules for approval of the knockoffs by the Food and Drug Administration.
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August 31, 2008
The Tennessean
David Charles, M.D. (Associate professor of neurology at Vanderbilt University and chairman of the Alliance for Patient Access)

Congress is considering two bills that could make practicing medicine in the U.S. a much riskier business.

Both bills pertain to state-of-the-art drugs known as biologics. Unlike conventional pharmaceuticals, which are created using simple chemical compounds, biologics are created from living organisms. They have proven to be some of the best treatments available for debilitating illnesses like cancer and multiple sclerosis.

Unfortunately, they are also some of the priciest.
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June 25, 2008
PRNewswire-USNewswire

The Congressional Budget Office (CBO) today released a cost analysis finding that the creation of an abbreviated pathway for follow-on biologics — or biogenerics — would save the federal government $6.6 billion over ten years and lower total expenditures for biologics by $25 billion over the same time period.

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