California Assembly passes bill on biosimilar drug use

August 28, 2013 9:34 AM

Pharmaceutical makers won approval from the California Assembly to restrict generic versions of drugs isolated from natural sources, such as vaccines, known as biosimilars, once they become available in the U.S.

The bill passed this week would require pharmacies to notify doctors and sometimes patients when a cheaper biosimilar drug is substituted for a brand-name medicine. It also would forbid a pharmacist from substituting the biosimilar drug if the physician says no.

“California should not jump the gun when the federal government has a process under way to sort out the benefits and risks of some of the costliest pharmaceuticals coming on the market,” Patrick Johnston, president of the California Association of Health Plans, said in an interview, referring to the U.S. Food and Drug Administration. “The FDA should finish its process and determine which drugs are suitable for substitution before California enacts any new laws.”

The bill, which passed 58-4, returns to the state Senate, where it was approved May 2, to reconcile changes made in the Assembly. Governor Jerry Brown, a Democrat, hasn’t said whether he’ll sign the bill.

Under current state law, a pharmacist can substitute generic drugs without notifying the prescriber. While no biosimilars have been approved by the FDA, they are allowed in Europe.

Geoffrey Eich, executive director for research and development policy at Amgen, said the company is investing in six biosimilars in addition to the biologics it manufactures. “We’ll benefit from the confidence patients will have in biosimilars,” he said in an interview.

“The bill imposes unnecessary physician notification requirements on pharmacists that could potentially reduce the number of prescriptions substituted with biosimilars,” a Calpers lobbyist, Danny Brown, wrote in an Aug. 21 letter to state Senator Jerry Hill, a Democrat from San Mateo who is the measure’s sponsor.

In testimony to the Calpers board the same day, Mandy Lee, a lobbyist for the California Retailers Association, said the biosimilars bill “is designed to derail the market entry of less-costly, more-affordable lifesaving products.”

Ten states have rejected legislation this year that would have regulated biosimilars. Four others approved such measures, though three put sunset clauses on the notification requirement, meaning the restriction will die after a certain number of years.


Source: Bloomberg

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