Biosimilar switching: Indiana condones but no big biotech gloom

By Gareth Macdonald

- Last updated on GMT

Indiana set for BIO backed biosimilars substitution laws
Indiana set for BIO backed biosimilars substitution laws

Related tags Federal trade commission Food and drug administration

Big Biopharma has backed passage of Indiana substitution laws that require doctors to grant pharmacists permission to switch a biologic for a biosimilar.

The proposed law – SB 262​ – permits pharmacists to switch a biologic drug for another deemed interchangeable by the US Food and Drug Administration (FDA) if the prescribing physicians has given explicit consent to do so.

Passage of the Bill – which is yet to be signed into law by Indiana Governor Mike Pense - was welcomed by the biopharmaceutical sector with the Biotechnology Industry Organiszation (BIO) being one of the most vocal supporters. 

SB 262 enjoys the support of a broad coalition of both biologic and biosimilar manufacturing companies. This bill includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record​.” 

The Indiana bill is markedly different from substitution laws in place in other states – Virginia for example​ – where pharmacists are allowed to switch unless directed not to by the prescribing physician.

Similarly, in Massachusetts pharmacists cannot switch if the doctor has specified that the prescription must be the innovator biologic, while in Washington State physicians have to indicate either “dispense as written​” or “substitution permitted​.”

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 Indiana vote 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 earlier this month 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​.”

Mark McCamish, global head of biopharma development at Sandoz, put forward a similar opinion. He suggested that the State laws coupled with the ongoing debate about how biosimilar products should be named are being used by innovator firms​ to dissuade doctors from prescribing alternatives.

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