US biosimilars in 2016: Where we're at following Zarxio's breakthrough

By Dan Stanton contact

- Last updated on GMT

Image: Muralinath/iStock
Image: Muralinath/iStock

Related tags: Fda

The coming year could see a spate of biosimilar approvals in the US following Sandoz’s success in 2015, according to an IP lawyer, but questions surrounding FDA’s requirements still remain.

The US launch of Zarxio - Sandoz’s copycat version of Amgen’s Neupogen - in September last year​ was a historic milestone, being a breakthrough in a market which was almost ten years behind Europe when it comes to biosimilars.

But while Zarxio is now available, questions surrounding its naming, pricing and interchangeability still remain unanswered, as do the regulatory requirements for a second wave of biosimilar poised to enter the market.

Biopharma-Reporter.com spoke with Andrew Williams, an expert on biopharma IP and a partner with McDonnell Boehnen Hulbert & Berghoff LLP, to find out how 2016 is shaping up on the biosimilars front:

Do you see a spate of biosimilars breaking through in 2016?

There has already been increased activity in biosimilar clinical trials in the past year, as well as an increase in the number of biosimilar applications filed with the FDA.  It would not be surprising to see this trend continue. 

What is unclear is what level of scrutiny the FDA will apply to more complex follow-on biologics.  For example, the next wave of applications will likely involve biosimilar versions of therapeutic antibodies.  Indeed, Amgen itself at the end of 2015​ filed its own application to market a biosimilar version of AbbVie’s adalimumab product, Humira.  If the FDA approves these applications with the speed at which it approved Zarxio, we certainly could see a spate of approvals in the upcoming year.

So are reference biologic makers in for a difficult 2016?

Logically, the major losers in this field will be the innovator companies that developed the original biologic drugs, many of which have claimed blockbuster status.  However, the acceptance of biosimilar drugs by the U.S. medical community is still unclear. 

Some physicians simply may be unwilling to take the chance at prescribing them. Moreover, if such drugs are only sold at a 15% discount (as was Zarxio when it was first marketed), the associated saving may not be deemed as sufficient to offset the perceived risk. 

This hesitancy should subside as biosimilar drugs become more commonplace, or as the price of such drugs fall.  In addition, the losses to these companies will be somewhat tempered by the fact that innovator companies are also filing 351(k) biosimilar applications.  For example, while Amgen stands to lose on follow-on versions of its products like Neupogen, it could also gain if its adalimumab biosimilar is approved.

What questions remain for biosimilar developers following the FDA’s approval of Zarxio?

Before Sandoz announced that the FDA has accepted its biosimilar application in 2014, the community began to wonder if any one company would take advantage of this abbreviated approval pathway.

One of the concerns was how much data the FDA would require to establish the “no clinically meaningful difference”​ standard for 351(k) biosimilar applications.  Sandoz had already had extensive experience with this product because it received approval to market this drug in Europe in 2009.

However, it is currently unclear to what extent this experience expedited review of the US application.  It remains to be seen what level of scrutiny the FDA will apply to biosimilar applications that do not have the data that a corresponding approval in another jurisdiction provides. 

Sandoz certainly had an advantage with Zarxio™ in regards to the amount of data it had already generated based on years of marketing a comparable version of the product in Europe.  It is unclear if the FDA will require more rigorous clinical trials for biosimilars without the same track record.

What about the interchangeability issue surrounding biosimilar products?

It is unclear if the FDA will ever find a biosimilar that meets the exacting requirement of the statute.  Specifically, the BPCIA requires for a biosimilar to be considered “interchangeable,”​ it must “be expected to produce the same clinical result as the reference product in any given patient,”​ and the risk “of alternating or switching between use of the biologic product and the reference product is not greater that the risk of using the reference product”​ alone.  It may prove to be easier to obtain approval of a new BLA than to meet this standard.

Andrew Williams' practice primarily consists of patent litigation, prosecution and opinion work in the biotechnology, pharmaceuticals and chemistry sectors. He is also a regular contributor on patent related issues to the Patent Docs​ blog. ​ 

Related topics: Markets & Regulations, Biosimilars

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