Biosimilars, bio-differences: Breakdown of US State substitution laws

By Gareth Macdonald and Dan Stanton

- Last updated on GMT

Biosimilars, bio-differences: Breakdown of US State substitution laws

Related tags Food and drug administration

The US biosimilars market is becoming complicated even before the US FDA has issued manufacturers with clear guidance, thanks to a rapidly evolving patchwork of varying State substitution laws.

When the Patient Protection and Affordable Care Act, also known as Obamacare, was signed into law in 2010 it included provisions for an approval pathway for new versions of existing biopharmaceuticals​, defining them as biosimilar to a reference drug if there are “no clinically meaningful difference​s” in safety, purity and potency.

The Act also defined when a biosimilar can be switched for an originator – its interchangability – by the dispensing pharmacist, again insisting on the drug having the same clinical effect as the original​.

The tricky bit – for biosimilars developers – is that it was left up to individual States to decide the precise requirements needed to substitute a biosimilar for a prescribed reference product.

To date Florida, North Dakota, Oregon, Utah, Virginia and – most recently – Indiana​ have introduced rules governing substitution while efforts to introduce legislation have failed in Arizona, Arkansas, Colorado, Delaware, Maryland, Mississippi, Texas and Washington.


But biosimilars firms thinking they can target their marketing efforts towards States that have passed laws should think again as the rules vary significantly.

In North Dakota, for example, pharmacists must tell the prescribing doctor within 24 hours of making a switch, retain a written record of the change for five years and tell the patient involved.

In contrast, in Utah and Virginia pharmacists only have to tell the doctor if they switch a biopharmaceutical for a biosimilar on prescriptions filled before 2015 when the requirement to do so expires. For Oregon pharmacists the same requirement runs out in 2016.

Pharmacists in Florida do not need to tell doctors, but they do have to tell the patient and keep a record of the change.

In California the plan was to require that the pharmacist notified the prescribing doctor within five days, however this was vetoed by Governor Gerald Brown who cited the lack of clear guidelines from the Food and Drug Administration (FDA) as the reason for blocking the law.

The FDA, which has jurisdiction for approving all drugs, has not yet determined what standards will be required for biosimilars to meet the higher threshold for “interchangeability.” Given this fact, to require physician notification at this point strikes me as premature​.” 

Related news

Show more