Michigan Bill to allow substitution for interchangeable biosimilars

House Bill No. 4812, printed and filed last month, amends several sections of the Public Health Code and would allow a pharmacist in Michigan to substitute a biologic drug for a cheaper biosimilar.

“Biosimilars are the next big thing in the biotechnology industry and the expected savings to consumers, the state of Michigan and insurance companies could be tremendous,”​ the Bill’s primary sponsor and member of the Michigan House of Representatives told Biopharma-Reporter.com.

“My legislation would establish a regulatory pathway for pharmacists to dispense these new medicines while keeping the patient and prescribing physician informed of what was dispensed.”​

Interchangeability​

Zarxio (filgastrim-sndz) is the only approved – and, as of yesterday, launched​ - biosimilar in the US but Novartis offshoot Sandoz did not seek approval of interchangeability in its Biologics License Application (BLA).

As such, Zarxio could not be substituted for Amgen’s Neupogen under the Michigan legislation as Bizon’s Bill only deals with interchangeable biosimilars, which must prove interchangeability as well as biosimiliarity in clinical trials, according to US FDA draft guidance published in May​.

The specifics differ from that of House Bill 5598 - introduced in Michigan in May 2014​ - condoning the switching of products based on biosimilarity alone.

But “last year's bill did not get enacted, so nothing is currently on the books,” ​Bizon told us. “Only interchangeable biosimilar drugs could be substituted with my proposal.”​

Inter-State​

The Patient Protection and Affordable Care Act of 2010​ – also known as Obamacare – set the wheels of motion for biosimilars in the US with the Biologics Price Competition and Innovation Act establishing a specific development pathway.

However, the Act left decisions surrounding the substitution of a biologic in the hands of individual State, a number of which have spent the last couple of years preparing for the introduction of biosimilars.

Fifteen months ago​, just six States – Florida, North Dakota, Utah, Virginia, and Indiana – had introduced specific rules, but since then a number of other States have introduced legislation to address the interchangeability of biologic products, including Georgia​, Utah​, California, Illinois​, Colorado​ and New Jersey​.