biosimilar drug substitution

MedicalTechnologies_Tubes2We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico. The latest version of our chart can be found here. As with the laws we’ve seen before, both the Iowa and Montana biosimilar amendments mirror the state’s existing generic drug substitution laws. More specifically, they amend state pharmacy laws to allow, and in some situations require, the substitution of interchangeable biosimilars. Continue Reading New State Substitution Laws, and a Busy Spring for Biosimilars

As our regular readers know, we’ve been tracking regulatory approvals, reimbursement policies, pharmacy substitution laws, and other developments related to biosimilar biological products. Biosimilars rely on the safety and efficacy history of an existing biological product for FDA approval by demonstrating that the biosimilar is “highly similar” to the reference product.  Recent weeks have been busy ones for state and federal officials involved in this area, and certainly the same can be said for developers of biosimilar products who need to keep pace with these rapid developments.

State Substitution Laws

As the 2016 State Legislative Session enters full swing (indeed, a few regular sessions have already adjourned for the year), we expect that more states will join Puerto Rico and the nearly 20 states that have enacted new laws or regulations specific to biosimilar substitution and dispensing as of the end of last year.  According to a recent tally by the National Conference of State Legislatures, at least 10 bills related to biosimilars (either newly filed or carried over from 2015) are pending this spring, many of which are very similar to laws already in effect in other states.

We are reporting that the “pending bills” number is 10 rather than 11, as the NCSL currently indicates, because the Kentucky legislature has joined several of its neighbors (Illinois, Indiana, Tennessee, and Virginia) in overwhelmingly approving an automatic biosimilar substitution law.  On March 29th, the bill was delivered to the Governor for signing, which he is expected to do.   Continue Reading Biosimilar Developments Continue at a Rapid Pace

In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the prescribed biological product. The National Conference of State Legislatures (“NCSL”) reports that through the end of 2014, eight states have passed biosimilar substitution laws and a dozen or more states have bills pending in their current legislative sessions. Moreover, at least one State Board of Pharmacy (Idaho) has taken action on biosimilar substitution by proposing an amendment to the regulations governing the practice of pharmacy. Many of the state provisions focus on the type of notice required for biosimilar substitution, who must be notified of the substitution, and when that notice must be conveyed.

Continue Reading States Move to Impose Limits on Biosimilar Drug Substitution