State House Sound Bites

Capitol reporter Katie Meyer covers Pennsylvania politics and issues at the Pennsylvania state capitol.
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State lawmakers girding for new drugs known as biosimilars

Written by Mary Wilson, Former Capitol Bureau Chief | Sep 11, 2013 9:35 PM

Pharmaceutical companies are gearing up for a new "breed" of medication to hit the U.S. market, possibly as soon as 2015, and some state lawmakers say they need to adjust state law accordingly.

Biosimilars are drugs - drugs that mimic another biological drug, but aren't exactly the same. They're available in Europe, but in the U.S., the medication's federal regulations are still being drafted. Those forthcoming rules are expected to identify certain biosimilars that are deemed to be "interchangeable" with the biologic medicine off of which they're modeled.

Pennsylvania law doesn't yet address biosimilars, so when they become available, the only way a patient could access them would be if a doctor specifically prescribed them. Some state lawmakers want to make it easier for patients to get such drugs, as long as pharmacists notify doctors about the substitution of biosimilars, and keep extensive records.

"My goal just to be clear is to have a complete medical record," said Rep. Bryan Cutler (R-Lancaster), sponsor of the proposal to tweak state law to address biosimilars. "If an adverse reaction occurs, that proper notification can occur and more importantly, timely notification can occur."

At a hearing Wednesday, patient advocacy groups testified the notification requirement is a good idea. Virginia Thomas has lupus and takes a biological drug called Benlysta to treat her disease.

"The thought of having my Benlysta substituted for a biosimilar, particularly without physician approval or my approval, is a scary one," she said.

Pharmacist groups say such notifications would be overly cumbersome. They differed on whether state law should make it easier to substitute biosimilars.

"There is no current risk in waiting," said Rick Mohall, with Rite Aid Corporation. "These products currently are not on the market. There is nothing for anyone to substitute at this point in time."

Cutler chalked up different viewpoints among pharmaceutical groups to their "position" in the market - some groups are in a position to sell biosimilars and want to make it easier for those medicines to be substituted, for example. From the patient's perspective, he said, the argument is simpler.

"Are there biosimilars that could be substituted in the future? We want to have that available," Cutler said. "Perhaps it's for cost reasons. Perhaps it's for difference in treatment - perhaps different in delivery method."

Brynna Clark, with the Generic Pharmaceutical Association, took up the cost savings argument.

"Interchangeable biosimilars have the possibility of saving up to 40 percent," said Clark. She said changing Pennsylvania law to allow the substitution of biosimilar medicine could save the state's Medicaid program millions of dollars. "This is a lot of money that's on the table."

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