Bill > A6209

Introduced Session

This bill improves access to lower cost generic and biosimilar drugs. Under the bill, certain guidelines are established to improve patient access to generic and biosimilar drugs in the State Health Benefits Program, School Employees Health Benefits Program, and the State Medicaid program. Among the bill's provisions, the bill provides a preference to biosimilars if a covered person or enrollee is prescribed a brand drug that the covered person or enrollee has not previously been prescribed, if a biosimilar drug is available. The bill provides that vendors that contract with the State Health Benefits Program and the School Employees Health Benefits Program, and managed care organizations that administer the State Medicaid program, publish an up-to-date, accurate, and complete list of all covered drugs in its formulary, including any tiering structure that they have adopted and any restrictions on the manner in which a drug can be obtained, in a manner that is easily accessible to covered persons, enrollees, and the general public. The bill also provides that if a generic or biosimilar drug is licensed by the FDA, is marketed pursuant to the generic or biosimilar drug's licensure, and has a wholesale acquisition cost that is less than the wholesale acquisition cost of the reference listed drug or reference product on the initial date of the generic or biosimilar drug's marketing, then vendors and managed care organizations that provide coverage for the generic drug or biosimilar's reference listed drug or reference product at the time of the generic drug or biosimilar's marketing date shall: (1) immediately make at least one biosimilar available on the formulary on a tier with more favorable cost sharing, including actual out-of-pocket costs, relative to the reference product; and (2) not impose any prior authorization, step therapy, or other limitation on coverage of a biosimilar for which formulary placement is required under the provisions of the bill, nor impose any restriction on a pharmacy through which a covered person or enrollee may obtain the generic drug or biosimilar that makes it more difficult for a covered person or enrollee to obtain coverage of, or obtain access to, the generic drug or biosimilar than the reference listed drug or reference product. Finally, the bill provides that a vendor or managed care organization does not have to provide coverage for a brand drug, generic drug, or biosimilar if the clinical and pharmacy experts that develop the formulary determine that the drug or biosimilar is no longer medically appropriate or cost-effective. For the purposes of this bill, "Biosimilar" means a drug that is produced or distributed pursuant to a biologics license application approved under 42 U.S.C. s.262(k) and that is not listed as "discontinued" in the Database of Licensed Biological Products of the FDA. . "Brand drug" means a drug for which an application has been approved under 21 U.S.C. s.355(c), or a biological product, other than a biosimilar, that is licensed under 42 U.S.C. s.262(a). "Generic drug" means a drug that is approved under 21 U.S.C. s.355(j) and is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations of the FDA as therapeutically equivalent to a reference drug, even if the manufacturer of such drug applies a trade name to the drug.

AI Summary

Committee Categories

Roy Freiman (D)*, 

Introduced, Referred to Assembly Financial Institutions and Insurance Committee (on 12/08/2025)

Official Document