Pre-emptive state legislation may hinder biosimilar adoption in US

In Massachusetts, recent legislation seeks to allow pharmacists to substitute biosimilars for biologics if the FDA deems them “interchangeable​,” but pharmacists cannot make that substitution if the doctor or prescriber calls specifically for the biologic.

Florida legislation lays out what seem to be onerous specifics for when a pharmacist can substitute a biosimilar. For instance, the pharmacist has to notify patients of the substitution and retain a written or electronic record of the substitution for at least two years.

Similarly, in North Dakota, pharmacists must notify physicians within 24 hours if a substitution is made, and they also must keep records of the substitution for no less than five years.

Jessica Mazer, assistant VP of state affairs at the Pharmaceutical Care Management Association, called North Dakota’s legislation the “most onerous​” for pharmacists.

But the state of Washington’s legislation seems to go the furthest in laying out the boundaries for biosimilar substitution. Physicians in Washington will have to indicate “dispense as written​” or “substitution permitted​” when writing prescriptions. In addition, pharmacists will be liable in cases where a biologic is substituted.

“The prescribing practitioner is not liable for a pharmacist’s act or omission in selecting, preparing or dispensing an interchangeable biological product​,” the Washington legislation says.

Bills enacted in Oregon, Utah and Virginia also require pharmacists to inform prescribers if there's a biosimilar substitution.

Backlash​

Despite the moves by states, which appear at face value to be industry driven, experts seem weary of these preemptive laws.

Bruce Leicher, SVP and general counsel at Momenta Pharmaceuticals mentioned at the FTC (Federal Trade Commission) hearing​ on biosimilars how in California, such legislation was vetoed by the governor.

"To summarize, the state laws conflict with federal law. It's a real burden on statutory provisions​," Leicher said.

The basic purpose of some of these laws was to prevent prescription error, but with electronic prescribing that point is basically moot, Leicher says. "States are being asked, in effect, to join in a commercial campaign to disparage interchangeable biologics​.”

But some seem to believe these additional precautions will help to keep the biosimilar market safe.

Sumant Ramachandra, SVP and chief scientific officer of Hospira, made it clear at the FTC workshop that biosimilars should not be treated like generics as any biologic or biosimilar differs from batch to batch.

“People who use this generic paradigm are not right​,” he said.

The battle over allowing or preventing the substitution of biosimilars also comes as disagreements over how biosimilars should be named brews. On the one hand, Amgen and other industry leaders argue that biosimilars should have distinguishable proprietary names, whereas others believe this will only cause confusion.

Mark McCamish, global head of biopharma development at Sandoz, said at the FTC workshop that identity is not the issue and the naming controversy is being used to cast fear over the safety of biosimilars.

"It's easy to convince a knowledgeable physician that a biosimilar connotes some risk​," McCamish said.