The biosimilar market is a rapidly-growing segment of the pharmaceutical industry, but the US is still in the early stages of developing biosimilar regulation. In recent months, several US states have been contemplating passing bills on biosimilar drug use, and the California Assembly is the latest to pass such a bill.
The Californian legislation would require pharmacies to notify doctors and occasionally patients when a generic biologic is substituted in place of a brand-name medicine, and would also forbid a pharmacist from making a substitution if the prescribing physician says no.
The bill, SB598, was passed by the California Assembly on a 58-4 vote, and will be returned to the state Senate for the final vote and the reconciliation of any changes.
California is home to numerous biotech companies, including Amgen. The Thousand-Oaks based biotech have been seated on both sides of the biosimilar debate – arguing for stronger restrictions on biosimilar substitution while developing a number of biosimilars themselves.
Ten states so far have rejected legislation on the regulation of biosimilars this year, while four others have approved such bills.
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If you're interested in hearing more about strategy and innovation in biosimilars, you might be interested in attending the World Biosimilar Congress Europe 2013, 12-13 November 2013.