Florida Senate committee passes biosimilar bill

Bill includes five-year sunset clause

WASHINGTON — A committee of Florida's state Senate has passed a bill that could limit the use of biosimilars in the state.

The Florida Senate Committee on Health Policy passed S.B. 732, sending it to the full state senate. The legislation would require pharmacists to inform doctors when a follow-on biologic was substituted for a brand-name biotech drug. The bill is similar to one signed into law last month by Virginia Gov. Bob McDonnell.

Like the Virginia law, the bill in Florida has a five-year sunset clause stating it will expire in July of the fifth year after the Food and Drug Administration's approval of a follow-on biologic as interchangeable with a branded biologic.

The legislation received support from the Biotechnology Industry Organization, a Washington-based trade group representing biotech companies.

"Biosimilars are not generics. Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and different manufacturing processes will rarely, if ever, be exactly the same, hence the name 'biosimilar,'" a statement from BIO in response to the legislation read.

 

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Comments

- 4:57 PM
chris22 says

It's a step in the right
It's a step in the right direction, even though much remains to be done regarding information regarding actual biological boundaries. Chris Stevens Swiss info travel

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