Tuesday, March 31, 2009

New Senate Bill Takes Shortcuts on Path to Biosimilars

Senators Charles Schumer, Sherrod Brown, Susan Collins and Mel Martinez have introduced a bill regarding the approval process for the approval of Biosimilars.

However, according to Biotechnology Industry Organization President Jim Greenwood, the bill proposed by Senators Schumer et. al. is essentially a recipe for disaster.

According to Greenwood:

“While well-intentioned, the bill introduced today by Senators Schumer, Brown, Collins and Martinez follows its companion bill in the House (H.R. 1427, The Promoting Innovation and Access to Life-Saving Medicine Act) through the looking glass to a world of biosimilars that would jeopardize patient safety and undermine future medical breakthroughs.

“The legislation short cuts scientific requirements needed to ensure patient safety and creates an imbalanced system that could chill investment in research focused on discovering new treatments and cures for devastating diseases, such as cancer, Alzheimer’s, Parkinson’s and multiple sclerosis.

“As the U.S. Food and Drug Administration (FDA) has noted, biotech drugs are so molecularly complex that they are almost impossible to replicate accurately with existing science. Even minor differences in the purity of a biotech drug can change its efficacy and safety. With this in mind, any biosimilars legislation should mandate that FDA approval of a biosimilar include clinical trial data demonstrating its safety, purity and potency. Yet this bill includes language that would discourage the FDA from conducting certain clinical trials.

“More, the bill unfairly tilts the playing field toward biosimilars manufacturers. This legislation provides for less data exclusivity than traditional pharmaceutical drugs currently receive under the Hatch-Waxman regime even though every credible study on this issue has found that biologics will need greater data exclusivity than traditional drugs to ensure future medical breakthroughs. Additionally, innovators would be required under the bill introduced today to share detailed information about every applicable patent to biosimilar manufacturers, making it easier for the biosimilar company to bypass valid patents. Innovators, on the other hand, would have no ability to receive relevant information from the biosimilar manufacturer about the molecules, ingredients, and processes they use to create the biosimilar.

“A successful pathway to biosimilars must strike the right balance in ensuring patient safety and providing fair, responsible incentives for continued biotech research into cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS and unmet medical needs. The bill introduced today fails to meet this reasonable metric.

“We urge Congress to ensure that any pathway for approving biosimilars is grounded in sound science, safeguards patient safety, and preserves incentives to develop future breakthrough therapies and cures.”

This topic is sure to be hotly debated over the coming months.....Stay tuned.

Monday, March 16, 2009

The Struggle for Baby Biotechs

Sally Church has a great post on her blog about the coming cash crunch for baby Biotechs.
You can read it here.
Actually you should visit Sally's blog often. Her posts are consistently top-notch.

Wednesday, March 04, 2009

Contradictory Supreme Court Decision and the Costs to Society

According to an article in the New York Times here - today's Supreme Court decision sets the following scenario:

An injured consumer can sue a drug maker — but not a medical device maker?

That seemed to be the contradictory result of a decision Wednesday by the Supreme Court, ruling that federal law does not protect drug companies from product liability suits in state courts.

In contrast, the Supreme Court ruled last year that federal law does bar such lawsuits against the makers of heart stents, artificial joints and other critical medical devices.

While legal eagles will debate the nuances of today's decision - here is the real issue:

"[Today's]....decision would make companies more reluctant to produce beneficial drugs that come with higher risks."

Everything you ingest, whether it is Steak, Peanut Butter, Aspirin, and even Water, carries with it an element of risk. you cannot eliminate risk.
As a society, the cost of not developing life saving but potentially risky drugs, is a cost that we cannot afford to bear.

Monday, March 02, 2009

Genentech: Worth More Than Pfizer?

I am going to have to file this post under the Category of things I never thought I would be writing - but according to an blog post on the Forbes website last Friday - Genentech is worth more [in terms of Market Cap] than Pfizer.

Matthew Herper writes here that:

"Check this out: This morning, Genentech's market capitalization of $91 billion exceeds that of much-bigger Pfizer ($84 billion.) Pfizer has annual sales of $48 billion, compared to $13 billion for Genentech....Over the past two years, Genentech shares have been basically flat, but Pfizer's stock has plunged more than 40%."

Who would of thought this was possible?

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