California Assembly passes controversial biosimilars bill

29 August 2013

In the USA this week, the California Assembly has passes legislation that would allow pharmacists to dispense biosimilars, substitute medicines that are biologically similar to brand-name treatments, after notifying prescribing doctors, according to various media reports. SB598 passed the Assembly on Monday on a 58-four vote and returns to the Senate for a final vote.

Biological medicines are becoming a fast-growing segment of the pharmaceutical market, with manufacturers also creating medications that are similar to some biological medicines. Unlike traditional generic medications, biosimilars resemble but are not identical to the biological medication they are replicating.

Federal officials are still in the early stages of developing regulations spelling out when biosimilars can be used. Meanwhile, state legislatures around the country have been debating the issue, with at least five states enacting laws specifying when pharmacists can substitute a biosimilar medication for a brand-name treatment, according to a staff analysis of the California bill.

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