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Wong Discusses Strength of Regulatory Actions


Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York, discusses recent regulatory actions to promote biosimilars.

In the first quarter of this year, key changes occurred that indicated new commitment among federal regulators to encourage biosimilar development.

The Center for Biosimilars® spoke about these developments with Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York. Wong has an extensive background on patent litigation, transactions, and contract negotiations in the pharmaceutical industry. He gave us his take on how these initiatives are likely to succeed.

Will manufacturers be motivated to bring products to market under the newly established biologics approval pathway under the Biologics Price Competition and Innovation Act?

There’s an important distinction to make. Many biologics that are subject to biosimilars today are older products and their regulatory exclusivity no longer applies. But if it’s a newer product, biosimilar manufacturers are looking at a horizon 12 years away for bringing their product to market based on regulatory exclusivity, so they might have less incentive to develop a biosimilar, even if it’s the same amount of work as making a small molecule generic. That’s 1 reason why we see so many companies making generic medications. In the generic industry, pursuing multiple potential generic products may be beneficial, even if you only succeed in bringing 1 to the market. It’s potentially worthwhile from a return on investment analysis, because you have the potential for 180 days of marketing exclusivity and have automatic substitutability at the pharmacy for the reference product. On top of that, the generic small molecule process is likely less resource intensive than developing a biosimilar.

With small molecule drugs, the intellectual property (listed in the Orange Book) that surrounds the product may be less extensive than what one might see for biologics. One reason for that may be the importance of manufacturing processes to certain biologics. Because of this, among other reasons concerning the general increased complexity of biologics, there’s potential to have more intellectual property surrounding the Biologics License Application product.

Whether there is incentive to pursue a biosimilar, as compared to small molecule generics, is likely to be a highly fact-dependent analysis.

Over the past 2 years, we’ve had multiple launches of biosimilars, so we’ll get a lot more information very soon on the biosimilars market. We’ll have a much more informed view of whether this is something people would want to be involved in or not, at least from the economics perspective.

Is it possible that the newly announced FDA/Federal Trade Commission (FTC) collaboration to fight anticompetitive practices will improve the marketplace for biosimilars?

It’s interesting that they are affirmatively looking out for and looking to address any potential anticompetitive practices. The FDA and the FTC can significantly impact the promotion and uptake of biosimilar products, and it’s important to see that they’re proactively seeking to understand and address them with concrete steps.

What may be concerning is that many of the steps they’ve identified so far are very broad or do not significantly add to their current purview. The points that they identified in their joint statement indicated that they want to promote a coordination between these administrations in order to promote competition in the biologic market by educating consumers and providers. That’s important, and they did come out with draft guidance on promotional labeling and advertising in the biologic space, but they generally don’t do more than they normally would have done. For instance, they essentially say that you need to be truthful and nonmisleading when advertising in the biologics space. That’s true for anything that you have in advertising. Just because they explicitly identify that a rule applies to biologics products doesn’t make it more stringent. They’ve provided no additional penalties for not being truthful or misleading with biologics advertising.

One of the examples they give of misleading content is suggesting that a biosimilar is less safe or less effective because it hasn’t been licensed as interchangeable. But a company doesn’t have to be that explicit. What if a company were to simply state that no clinical studies had been conducted to demonstrate that the biosimilar can be switched with the branded product? That’s just a factual statement. Is that suggesting that the product is less safe or less effective?

What the average consumer might understand from that representation is unclear. For this to be helpful, the FDA and FTC will have to address the hard questions, and not simply address the easy questions that we already know the answers to.

It certainly may be helpful, though, that the FDA and FTC did say that companies can request an explicit review of draft promotional materials through the current process for submitting an application. That isn’t necessarily significantly different than just submitting it, because you’re going to get their comments anyway, but it may be helpful to request an explicit review of draft materials to ensure that one gets specific guidance on materials that may be concerning.

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