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State Lawmakers Considering Regulations for New Biosimilar Drugs

State lawmakers are considering regulations for what some call a whole new “breed” of medicine not yet on the U.S. market.

A biosimilar medication is a drug created to mimic another medication without being biologically exact.
The drugs are allowed in Europe, but in the U.S., federal regulators are still drafting rules for the drugs — like which ones will be deemed “interchangeable” with other biologic medicine.

In anticipation of such regulations, Republican state Rep. Bryan Cutler of Lancaster County is proposing to allow the substitution of such federally sanctioned biosimilars under Pennsylvania law.

"I think it’s going to become a more and more important piece of the health care debate as we move forward related specifically to cost as well as patient care," he said.

Cutler says state law is currently silent on the use of biosimilars, so patients could not receive them unless their doctors specifically prescribed such drugs.

Patient advocacy groups say they support the legislation, so long as pharmacists and physicians communicate with one another about the substitution and keep a record of it.

Pharmacists suggest such rules for notification could be overly cumbersome.

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