It seems that AbbVie has won the battle and the war. The last remaining holdout in the fight to bring a biosimilar adalimumab to market before 2023 has capitulated, as AbbVie announced May 14 that Boehringer Ingelheim agreed to the terms of a licensing arrangement. This agreement allows Boehringer Ingelheim to enter the marketplace July 1, 2023, getting a slight jump on some other licensees, but it effectively ends the protracted patent litigation that Boehringer hoped to win.
In an interview with BR&R, Molly Burich, Boehringer Ingelheim’s Director, Public Policy, Biosimilars and Pipeline, told us in October 2018, “We are committed to making Cyltezo® available to US patients as soon as possible and certainly before 2023.”
WHICH COMPANIES HAVE SIGNED LICENSING DEALS WITH ABBVIE?
|Company/Partner||Drug Name||Launch Date|
|Samsung Bioepis/Merck||SB5||June 2023|
|Boehringer Ingelheim||Cytelzo*||July 2023|
|Mylan/Fujifilm Kyowa Kirin Biologics||Hulio||August 2023|
|Fresenius Kabi||MSB11022||September 2023|
|*Received FDA Approval.|
However, at that time, Ms. Burich also disclosed that Cyltezo would not be commercialized in Europe; in October, the stampede of biosimilar manufacturers had just left the starting gate. In addition, Boehringer had earlier decided to drop plans to develop other biosimilars in the pipeline and focus solely on Cyltezo. That would seem to leave Boehringer out in the cold until July 2023.
In response to BR&R’s query, Susan Holz, Boehringer’s Director of Communications, Specialty Care, provided the following statement: “As we previously shared, at this point in time, our focus remains on providing patient access to our biosimilar Cyltezo in the US, and future biosimilars activities will be driven out of this market. Boehringer Ingelheim continuously evaluates our business portfolio, and we assess potential strategic partnerships to help enhance our pipeline and development capabilities. As you know, we have stopped development activities for the rest of the world, and I am not able to comment on specifics regarding our biosimilar in- or out-licensing strategy.”
Boehringer Ingelheim had reported that it is seeking the interchangeability designation for its adalimumab biosimilar. In the possible scenario where Cyltezo won its patent challenge, and gained the interchangeability designation from the FDA (note that FDA only issued its final interchangeability guidelines draft this week), the marketing potential was rosy indeed. However, suppose the FDA approves the interchangeability label for Cyltezo. It cannot leverage it until after Amgen’s and Samsung Bioepis’ adalimumab biosimilars have launched. Will it have the same advantage? That’s difficult to say. Payers will be anxious to grab immediate savings on this product, and interchangeability may not be considered such a great benefit. That is, in four years, will payers routinely switch available biosimilar agents anyway? My guess is that health plans and insurers will be leaning in that direction.
On the other hand, it will be easier to automatically switch patients in nearly every state. That lever will only be used if Boehringer gives payers a real reason to use it—a significantly better deal than the existing options. AbbVie offered huge discounts (on the order of 80% in some countries) in an effort to hang on to some marketshare once biosimilars were available in the EU. After all, why worry about interchangeability and switching when you can continue to use Humira® at a 75% discount?
Ms. Holz told BR&R, “In regards to interchangeability, this is a very important issue for many stakeholders, as it is the catalyst for automatic substitution at the pharmacy level, which in turn may help drive efficient use of biosimilars and maximize the cost-saving potential of these important medicines.” She added, “We were very pleased to see the Agency finalized interchangeability guidance that retained the appropriate balance between a high-bar to prove interchangeability and product-specific flexibility to make such a status attainable.”
In the next four years, the price of Humira will undoubtedly rise. This will mean that savings gained in 2023 will be little more than money lost to the system over the previous 48 months. As significantly, it represents tens of billions of dollars into AbbVie’s bottom line from a product that was approved in the US 17 years ago.