Michael Werner
The Food and Drug Administration approved the first biosimilar drug, Zarxio, in March 2015, and the second one, Inflectra, this past April. Shortly after the approval of Zarxio, several biosimilar drug manufacturers formed the Biosimilars Forum, an educational and advocacy organization based in Washington, D.C.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Recently, the Biosimilars Forum’s senior policy advisor, Michael Werner — who is also a partner at the law firm of Holland and Knight — talked with MedCity News about what’s going on with biosimilars.
What is the Biosimilars Forum and who are the members?
We are manufacturers of biosimilars in the United States. We have traditional generic-brand companies and companies that do both [generics and branded drugs]. We hope that our membership will expand to include other stakeholder groups such as patients, clinicians and other folks who want approved biosimilars in the United States.
How many biosimilar drugs do you anticipate will be approved soon?
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
We know that there are 70 biosimilar products in the FDA’s biosimilar development program. They are far along enough in development that they are talking with the FDA and paying FDA fees. That is a lot of products in the pipeline.
What sort of educational resources do you have available for physicians?
We are developing and constantly improving our educational program. We are not trying to ask for adoption of any particular product. We provide information of what biosimilars are, what is the science behind them, what is the FDA’s approval pathway, what is the value of biosimilars. We [provide education] through [channels such as] journals, social media and the ASCO meeting.
Are biosimilars the same as generic drugs?
Biologic drugs are complicated biological products and oftentimes the manufacturing process is proprietary. The biosimilar might not be exactly the same. So, instead, what the FDA looks for is if it is similar and provides the same clinical benefit. There is a requirement for the biosimilar manufacturer to do clinical trials and provide clinical data to the FDA. Roughly speaking, it is more than what is required of a generic drug, but not a full data package like a reference product for a new drug. I think it is fair to say that an easy way to think about it is that a biosimilar is to a biological drug like what a generic drug is to a drug, even though it is not exactly the same thing. It is just a little more complex.
What is an interchangeable biosimilar drug?
If your doctor prescribed Lipitor, for example, your pharmacy has the legal right to switch and give you the generic product [because it is an interchangeable drug]. And so it is in the biosimilar space. The pharmacist is allowed to give you the biosimilar [interchangeable drug] even if the physician orders the branded drug.
Not every biosimilar will be interchangeable; it is a subset of biosimilars. In order to get the interchangeable status, the manufacturer has to have additional testing to prove there is no difference. It is meant to be a higher bar. The two approved biosimilars [Zarxio and Inflectra] do not have interchangeable status.
Why does the Biosimilars Forum oppose the Centers for Medicare and Medicaid Services’ proposed rule for reimbursement of biosimilar drugs?
For Medicare purposes, all biosimilar drugs tied to the same reference product are going to get the same payment. They will have the same code for billing. We really believe that Congress had the intention that each biosimilar gets paid under its own formula. Because biosimilars are not the same as each other, it doesn’t make sense that the payment [for each biosimilar tied to a reference product] is the exact same amount.
On average, how much cheaper will biosimilars be compared with branded biologic drugs?
That is a case-by-case discussion about individual products and their reference products. We assume they will be cheaper; how much cheaper they will be I don’t know. The theory behind a biosimilar is that because it doesn’t have to go through the full development process, it will be [less expensive].
Do you have any other comments about the Biosimilars Forum?
Our mission is to promote a vibrant biosimilars market in the United States. We are engaged in virtually every policy issue — reimbursement, regulatory — and I think we’ve made an impact because we are a place where people in this space can come together and work through issues.
Photo: Flickr user bettyx1138
