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Ha Kung Wong: The Importation of Biologics and Biosimilars


Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, discusses the Trump administration's proposal to allow importation of drugs, including biologics.


Were there elements of the Trump administration’s blueprint on reducing drug prices that caught your eye?

So this document, entitled “American Patients First” and which was released in May of 2018, has a lot of different aspects to it. Although this idea wasn’t specifically delineated in the May 2018 blueprint, which isn’t surprising seeing the lack of detail in that release, the Trump Administration has recently included the idea of importing drugs from other countries as part of meeting some of its stated goals. This is particularly interesting in the context of biosimilars.

My understanding is, pursuant to this plan, that the FDA will form a working group to explore importation in cases where a manufacturer suddenly increases the price of a drug that doesn’t have any competitors. It’s also my understanding that importation would only be allowed for drugs whose patents and exclusivities have already expired.

As an initial matter, this means that this importation is unlikely to impact access of more cutting-edge medications, which significantly limit its impact on drug prices. So it’s unclear whether this plan would significantly address any of the stated goals.

But more specific to biologics, as a practical matter, it may be difficult to determine whether all the patents have expired given there is no current listing of patents covering biologics products like there is in the Orange Book for small-molecule drugs. So it may be difficult to determine whether you apply for this or not.

There are also concerns about how we will determine whether these imported drugs are as safe as those approved by the FDA. This is especially concerning in the biologics context where no 2 drugs are exactly identical in the way that a small-molecule drug can be.

As an example, even if you’re using the exact same process and the exact same machinery, producing a biologic in Seattle will be different from producing one in Phoenix, will be different from Miami, and so on and so on. Based on differences in environmental conditions, ambient temperature, all that—it can completely change the product that you’re going to get.

And then there’s also just normal product drift even in the same manufacturing location with biologics. That’s because most biologics are manufactured from living cells, which may have significant variance from cell culture to cell culture even without considering the surrounding environment. It seems allowing importation of biologic drug products into the United States, without further FDA oversight, could create a loophole for avoiding the costly biosimilar approval process in the United States, which may ultimately also create potential safety concerns.

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