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Biosimilar legislation: Important work for the GA

Date published: 1/31/2013

DRUGS produced by a biological process (rather than by being synthesized from various chemicals) are called "biologics." Their offshoot "generic" versions are called "biosimilars." Now, the General Assembly is poised to help Virginia patients have access to these important pharmaceuticals, which become available beginning this year.

Federal law gives the FDA authority to determine if a biosimilar is the equivalent of a biologic drug, but it leaves rules regarding substitution to the states. A couple of weeks ago, the House of Delegates passed a bill establishing those standards for Virginia. Now the Senate and the governor must act.

Biologics targeting some autoimmune diseases and some cancers are on the market now. Examples include Remicade (used for rheumatoid arthritis, Crohn's disease, and other conditions) and Herceptin (breast cancer). As their patents run out, these biologics may be "copied." A "biosimilar" is the result. Like a generic, it's cheaper to buy.

But due to the nature of the process, it's impossible to exactly reproduce a biologic, even under FDA scrutiny. So rules, like informing the patient and notifying the prescriber before a biosimilar is substituted, are in order. That's just what the House bill, introduced by John O'Bannon, R-Richmond, does. The Senate bill strips out some of those important safeguards, notes Virginia T. Ladd, president and executive director of the American Autoimmune Related Diseases Association, an error that should be fixed before the bill comes to the floor.

Passing this legislation will help the thousands of Virginians who suffer from certain diseases find some relief. There's hardly a better reason for the Assembly to act.