Meet the Editor – September

Q&A With September’s Featured Editor: Josh Whitehill

Josh Whitehill is an associate in Goodwin’s New York office.

BMW: Where would we find you on a Saturday afternoon?

Josh: On a Saturday afternoon, you’d find me trying to convince my twin 7-year-old boys, through reverse psychology, bribery or other trickery, to go play outside or to come with me on a walk in Brookdale Park with our puppy Argus. In the afternoon, you might find me with them down the street at Holsten’s getting their world-class ice cream, while European tourists flood the place on their Sopranos tour of northern New Jersey. Later in the day, you’d probably find me in our backyard or at a neighbor’s grilling or watching a game.

BMW: If you could make one rule that everyone must follow, what rule would you make?

Josh: Now this might be a little bit contentious, but under no circumstances other than medical reasons, a leaky window, or a dirty seat should anyone be permitted to sit in the aisle seat of a bus or train while the window seat is empty and people are still boarding. This is a society, people!

BMW: What do you see as the most important issue facing biosimilar applicants today?

Josh: An issue that has drawn considerable attention recently—perhaps most notably from FDA Commissioner Scott Gottlieb—is the relatively few biosimilar launches and slow biosimilar market uptake in the U.S., particularly in comparison to Europe.  Although the FDA has approved twelve biosimilars under the BPCIA framework, only four are currently on the U.S. market, with only one new launch per year since 2015.  While it is true that many more biosimilars are on the market in Europe than here in the U.S. and uptake in Europe has been stronger, the U.S. biosimilar market is also several years younger than the European market, and many other factors influence this rather complex and unique market. Commissioner Gottlieb recently labeled the U.S. biosimilar market “anemic,” which he attributed primarily to the relationships between branded drug makers and payors through rebate strategies and long-dated contracts, as well as so-called patent thickets—all issues not really within the FDA’s purview. Still, I think Dr. Gottlieb’s comments rightly addressed concerns that he and many others are having in these early days of the U.S. biosimilar market and were intended to bring these issues to the forefront of discussions among industry and government to implement changes wherever necessary to get the ball rolling for U.S. biosimilars and produce cost-savings for consumers.

There does seem to be a lot of misinformation or misconceptions in comparing the European and U.S. biosimilar markets.  For example, many have particularly called out the disparity in how the adalimumab biosimilar markets are shaping up in these jurisdictions.  While multiple adalimumab biosimilar launches have been announced for Europe starting as soon as October 2018, no one seems to be planning to launch an adalimumab biosimilar in the U.S. in the immediate future, and AbbVie has entered into agreements that authorize sales of adalimumab biosimilars in the U.S. starting in 2023.  The main reason for this discrepancy seems to be the starkly different patent landscapes in Europe and the U.S., which also of course have different patent law regimes. The focus often seems to be on the European and U.S. market formation dates themselves, instead of on the possible reasons for the disparity.

With regard to the perception that biosimilar uptake in the U.S. is slow, it is difficult at this point, with so few data points, to say with any certainty that biosimilar uptake will generally be slow in the U.S. going forward and across the board.  Uptake has been slow so far in the U.S. for infliximab biosimilars, but this is the subject of a major lawsuit, and it does not mean that uptake will necessarily be slow for biosimilars across the board or for other biosimilar products.  Still, I think the FDA is right to call attention to this potential problem and to do whatever it can, in conjunction with other agencies, regulators and, potentially, legislators, to assure that the U.S. develops a robust biosimilars market as soon as possible.  There are complex legal and economic factors at play here, and with companies investing hundreds of millions of dollars into developing biosimilar pipelines and with drug prices being what they are, we shouldn’t be willing to take the risk that biosimilars will be a bust in the U.S. healthcare system.

To learn more about Josh Whitehill, click here to view his full biography.