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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.
Biolink.us
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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.”
Biolink.us
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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.
Read More on BioLink:
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