BILL NUMBER: S8465

SPONSOR: RIVERA
 
TITLE OF BILL:

An act to amend chapter 357 of the laws of 2017 amending the education
law and the public health law relating to the substitution of inter-
changeable biological products for prescribed products, in relation to
making such provisions permanent

 
PURPOSE OR GENERAL IDEA OF BILL:

To make permanent existing law that allows pharmacists to substitute
biosimilar medications under certain conditions.

 
SUMMARY OF SPECIFIC PROVISIONS:

The bill amends the enacting date of the original statute to strike the
sunset of that law.

 
JUSTIFICATION:
              

Biologic therapies have revolutionized the treatment of complex chronic
diseases such as cancer, heart disease, arthritis, multiple sclerosis,
HIV/AIDS, among others. There are currently more than 200 FDA approved
biologic medications. Like the generic drugs that pharmacists may
substitute for their branded counterparts, the federal Food and Drug
Administration approves biologic medications that are interchangeable,
referred to as "biosimilars". Because the interchangeable biosimilar is
not an identical molecule as is the case with generic drugs, a separate
law was required to authorize the substitution.

The current New York law permitting substitution with FDA-approved bios-
imilar products is similar to the law authorizing substitution of gener-
ic drugs for brand-name drugs.

The biosimilar law will sunset in October 2022. This bill would make the
existing law permanent. This bill will ensure that patients with diffi-
cult to treat and rare conditions will continue to benefit from the
availability of biologic medications that are designated as interchange-
able by the FDA.

 
PRIOR LEGISLATIVE HISTORY:

New bill.

 
FISCAL IMPLICATIONS:

None.

 
EFFECTIVE DATE:
Immediately.