California Senate Passes Biosimilar Substitution Bill with a 31 to 4 vote and Now Awaits Committee Assignment in the Assembly.

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California is the latest U.S.

state to pass biosimilar

substitution legislation.

California’s Senate has passed the

biosimilar substitution bill, SB 671 (Hill),

by a vote of 31 to 4 on May 22.

Previously vetoed in 2013, the bill is

currently awaiting committee assignment

in the Assembly. The bill authorizes a

pharmacist to substitute an alternative

biological product when filling a

prescription for a prescribed biological

product under specified circumstances.Biolink.us

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Provisions of the legislation include:

• Only FDA-designated interchangeable

biologics may be substituted.

• Prescribers may prevent substitution

by writing “do not substitute” on the

prescription.

• A pharmacist must communicate a

substitution to the prescriber and

patient within five days of dispensing

the product.

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In a press release praising this latest

legislative development for

biosimilars, the California

Rheumatology Alliance said: “This

important milestone means that the

discussions around biosimilar bills in

state legislatures are no longer

conceptual.”

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According to the National

Conference of State

Legislatures website,

biosimilars substitution

legislation has already been

passed into law in Delaware,

Florida, Indiana,

Massachusetts, North Dakota,

Oregon, Utah and Virginia.

These laws apply to the

substitution of biosimilars at

the retail pharmacy level, but

not to mailorder

pharmaceutical sales.Biolink.us

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Meanwhile, California joins other U.S.

states including New Jersey,

Pennsylvania, Texas and Illinois with

legislation pending passage into enacted

law.

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