Californian governor vetoes biosimilars bill

The governor of California, Jerry Brown, has refused to sign legislation seeking to introduce changes to the state’s pharmacy law on biosimilars.

Biosimilars are manufactured to closely mimic biologic products – which are made from living matter.

While biosimilars are yet to be approved by the US Food and Drug Administration (FDA), numerous US states are addressing the standards for substituting them for biologic products.

The Californian bill, known as SB 598, would allow “interchangeable” biosimilar drugs to be substituted for biologic products.

It would also require pharmacists to notify prescribers about which drug was dispensed.

While Brown said he strongly supports the bill’s first provision, the second is “highly controversial”.

“Doctors with whom I have spoken would welcome this information. CalPERS and other large purchases warn that the requirement itself would cast doubt on the safety and desirability of more cost-effective alternatives to biologics,” he said.

“For these reasons, I am returning SB 598 without my signature.”

In California, which is one of several states to address biosimilar legislation, the bill was approved unanimously by both the assembly (in August) and the senate (in September).

After the bill’s rejection, the Biotechnology Industry Organization (BIO), which has supported the draft legislation, said it was “disappointed” by the governor’s decision.

“The vetoed bill ... properly preserved patient access to accurate prescription information, maintained incentives for innovation and promoted a competitive market for biologic therapies. The bill included full transparency in the substitution process – providing patients and their physicians the right to know what biologic medicine the patient receives from the pharmacy.”

In contrast, the Generic Pharmaceutical Association (GPhA) said Brown had “demonstrated compassion for millions of patients” by vetoing a bill that would have “impeded access to new biosimilar medicines”.

It said opposition to this and similar bills remains because the laws would add “unneeded burdens to the dispensing of biosimilar medications that will drive up costs”.

Sheila Swaroop, partner at Knobbe Martens Olson & Bear LLP, said owners of biologic products want to ensure patients know what they are being prescribed, so they are in favour of limiting pharmacists’ ability to substitute biologic products.

But biosimilar applicants want to give pharmacists the freedom to make decisions without putting hurdles in the way, she said.

“There are a lot of companies on both sides of this issue – it’s an interesting dynamic.”

Don Zuhn, partner with McDonnell Boehnen Hulbert & Berghoff LLP, added that companies producing biologics “might be attacked, but you can’t stay out of the mix if there is an opportunity on the other side of the fence”, so many are considering making biosimilars.

"Innovators are learning how to compartmentalise ... There is one biotech company, which I cannot name, that initially opposed biosimilar manufacture, but in the last year or so they are now getting involved."

Asked for his reaction to governor Brown’s decision, Zuhn said he disagreed with it.

“There was nothing in the bill that seems too onerous.”

“But the decision is incomplete, as we don’t know if the legislature will tweak the bill and send it back – keep in mind the overwhelming support beforehand.”

He added: “And when the FDA comes out with the interchangeability standards, I imagine they [the Californian legislature] will tweak the bill to incorporate that.”

According to the GPha, legislation similar to SB 598 has been blocked this year in 10 states, enacted with amendments in three states, and enacted with provisions backed by Amgen and Genentech, which supported the Californian bill, intact in only one state (North Dakota).

“Florida enacted a law that promotes access to biosimilars without burdensome physician notification requirements,” a statement added.

Zuhn said while he doesn’t know when the FDA will finalise its standards for biosimilars, they are “long overdue”.