Biosimilar State Pathway Battle

Currently there is a state by state battle happening all over the country. And for once I am not talking about gm labeling. The battle is over establishing state biosimilar pathway. Because this is a very complicated issue and highly polarized I am going to borrow heavily from BIO’s “Principles on Patient Safety in the Substitution of Biologic Products”.

Before we get started, my disclaimer: This blog does not represent iBIO’s position on this issue and I am in no way attempting to take my own position.


What are Biologics? Biologics are complex medicines manufactured from living organisms. Unlike traditional “small molecule” drugs, biologics are not chemically synthesized but rather are manufactured from living cells by programming a particular cell line to produce a desired therapeutic substance in a highly controlled sterile environment. Each individual biologic therapy is a complex, heterogeneous mixture, which in many cases cannot be well characterized by current science. Because of this complexity, even minor differences in manufacturing processes can cause variations in the end product. Consequently, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same.

What are Follow-on biologics or “biosimilars”? They are biologic products manufactured using different cell lines and manufacturing processes with the goal of closely mirroring the composition and treatment profile of an innovator product produced by another company. Due to the innate complexity of biologics in general, however, the production of biosimilar products will invariably lead to some differences between the composition of a biosimilar and the original innovator product, and these differences could potentially lead to clinical differences in a patient’s experience or reaction. In other words, unlike generic copies of traditional small molecule drugs, biosimilar biologic products will be therapies that are similar to, but not the same as, an innovator therapy.

Whats going on right now?

Currently, the FDA is developing guidance regarding the regulatory pathway for the approval of biosimilar and interchangeable biologic products. This approval pathway was established by federal law, and distinguishes clearly between biologic products that are “biosimilar” to an innovator biologic – meaning they are “highly similar” to an innovator product – and biologic products that meet a heightened standard to be deemed “interchangeable.” The standard for interchangeability in the law is a stringent one; one that is consistent with the FDA’s role in protecting patient safety. In order to deem a biologic product interchangeable with an innovator product, FDA must determine that a biologic is not only “biosimilar,” but also that it “can be expected to produce the same clinical result as the [innovator] product in any given patient.” Further, if a patient might be switched back and forth between two products, the FDA must determine that there is no additional risk in such switching compared to using the innovator product alone.

Why are the State’s involved?

While FDA’s role in the approval of biologic and biosimilar medicines includes the designation of an interchangeable status, the policy on whether one biologic product may be substituted by dispensers when a different biologic product was prescribed is governed by state law. As such, the introduction of biosimilar and interchangeable biologics into clinical practice will present some new challenges that have not historically been present with small molecule generic medicines. In considering patient safety and pharmacovigilance monitoring, current state rules on substitution will very likely need to be updated or completely re-written in the context of biosimilar and interchangeable biologic medicines.


Once again this is a very highly contencious issue. There have been a growing number of news stories and opeds in the Wall Street Journal and in Chicago Crains about the State implementation of a biosimilar pathway.

Virginia was the first state to pass a Biosimilar Pathway. Illinois has a bill in the house, but there is a lot of confusion and discussion about the bill. This is a very complicated issue, and it is important that a proper pathway is established without creating barriers to access for patients and barriers for biosmiliar manufacturers.

The discussion is focused on should biosimilar pathway just be a copy of the current generics pathway. The sticking point is doctor notification. Should the pharmacist notify the doctor that a substitution has taken place. The argument on one side is that since biologics are more complex than a chemical drug, you can not have a perfect copy of the therapeutic. Biosimilars can have different effects from the branded drugs and it is important that the prescribing doctor have a record of exactly what drug their patient is on in case complications arise. The other side of the argument is that if the FDA has determined that the therapy is a biosimilar and safe for the treatment, then there is no reason for concern, and provision will just make the public leary about biosimilars.

This pathway needs to be set before biosimilars hit the market here in the US, and it would be easier to work this out if the FDA issued final guidance, which they are expected to do at some point this year. The draft guidance issued last year provided some insight but still did not answer some major questions.

How similar should the biosimilar copies be to their innovator drugs?

How should biosimilar drug makers demonstrate the safety of their products?

How should interchangeability of biosimilars to innovator products be determined?

How should biosimilars be named and labeled?

Companies are eager for the final guidance since 12 blockbuster biologics making $67 billion in sales are coming off patent in the next 8 years. The biosimilar segment is an attracting market for many drug makers because it is expected to grow from $172 million in 2010 to $3.927 billion by 2017.

Click here to see a list of the Top 10 biosimilars either being sold somewhere in the world or is in clinical development. You will notice one of our community members is a leader in the biosimilar market, Hospira.

Click Here to read BIO’s “Principles on Patient Safety in the Substitution of Biologic Products.”

As this legislation continues I will provide updates, I’ll also do some features on the biosimilar market and the major players, especially those here in our community.

This is a conversation, not an editorial. Did I forget something, get it wrong or do you agree? Please Comment, Like, Re-Tweet and Share

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