Biosimilar Developments Continue At A Rapid Pace

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