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Generic Biologics – U.S Panel Hearing Draws Mixed Response

There are varied reactions to the U.S panel hearing that cheaper versions of biologic drugs// can be manufactured.

The Senate Health, Education, Labor and Pensions Committee is considering legislation that would give the Food and Drug Administration legal authority to approve alternative versions of expensive biologic drugs after patents expire.

Yet it has drawn both brickbats and accolades from various sections.

Says Jay Siegel, head of research for Johnson & Johnson's biotechnology business: ' You just can't take a molecule that you don't know what it is and market it to the people. It's too risky.'

He opines that rival products also known as follow-on biologics should be put up for extensive clinic studies and post approval studies before approval.

Nicolas Rossignol, who oversees implementation of the European Commission’s legislation on biosimilars, told the panel some biologics like insulin and human growth hormones are fairly simple to produce as generics, but that other more complex biologic drugs cannot be reliably duplicated. In general, European regulators advise caution.

Ajaz Hussain, who oversees biological drugs for Novartis AG's generics unit Sandoz,in contrast says science reveals that follow-on biologics can treat the same conditions as their more expensive counterparts.

'FDA already has the expertise' to review them, he told the panel. 'What you need to do is to empower them to act.'

His feelings are echoed by AARP (representing millions of American seniors, and America's Health Insurance Plans) President Erik Olsen:'A therapy is only helpful to the patient who has access to it.

'Biologics hold great promise for treating serious diseases such as cancer, multiple sclerosis, anemia and rheumatoid arthritis, but when some treatments cost thousands of dollars per dose, many patients cannot afford to fill their prescriptions.

'Science has progressed to t he point where it is possible to create generic biologics and to do so safely. All FDA lacks is the authority to approve these therapies,' he added.

The repercussions of the decision will extend to other areas.

Employers and insurers see this development as a means to curb skyrocketing health care cost.

In addition to private health providers, the U.S. government, which runs the Medicare and Medicaid insurance programs for the elderly, disabled and poor, also stands to save millions of dollars.

While different politic parties support diverse views, Sen. Mike Enzi, Wyoming Republican advises caution, ' Any time we start legislating on complex scientific issues and don't know all the facts, we risk endangering lives.'
ANN
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