UPDATE
Indiana biosimilar switching requirements become law
Governor Pence signed Senate Bill 262 into law last night, one month after the politicians in the State Senate backed the new rules.
In a statement last night the Biotechnology Industry Organisation (BIO) said: “Senate Bill 262 received overwhelming bipartisan approval and was supported by a broad coalition of biologic and biosimilar manufacturers, along with industry, physician and patient groups.”
BIO CEO Jim Greenwood said: "Governor Pence added Indiana to a growing list of states, including Florida, Virginia, Oregon, Utah, and North Dakota, that have taken a leadership position in allowing commercial pharmacies to dispense this class of cutting-edge medical therapy."
Altered States
However, as BioPharma-Reporter.com reported last month, the Indiana bill is markedly different from substitution laws in place in other states.
In Virginia for example pharmacists are allowed to switch unless directed not to by the prescribing physician.
While, in Massachusetts pharmacists cannot switch if the doctor has specified that the prescription must be the innovator biologic, and in Washington State physicians have to indicate either “dispense as written” or “substitution permitted.”
Meantime in North Dakota, pharmacists must tell the prescribing doctor within 24 hours if a substitution is made and then keep records of the switch for at least five years.
BIO’s reaction to the new Indiana law is unlikely to be shared by the biosimilars sector if comments made by various manufacturers at a US Federal Trade Commission (FTC) hearing on the topic In February are any indication.
Speaking at the event in Washington DC, Bruce Leicher, SVP and legal counsel at Momenta Pharmaceuticals, said: "States are being asked, in effect, to join in a commercial campaign to disparage interchangeable biologics.”
CORRECTION - Our original article said Mark McCamish, global head of biopharma development at Sandoz, had been against the Indiana bill.
In fact Sandoz welcomes the passage of the Indiana bill and sent us a statement saying itself and parent company Novartis: "Are supporting an approach that will help to ensure equitable, consistent and procompetitive state-level legislation.
"Under this approach, state pharmacy laws across the US would be updated in a consistent manner to enable pharmacy level substitution of all biologics determined by the FDA to be interchangeable."
