As we inch closer to the January 2023 date for the launch of the first US adalimumab biosimilar, industry watchers are more closely scrutinizing which company, if any, will have a competitive advantage in this lucrative marketplace.
Just to reset, the series of settlements signed by AbbVie currently puts Amgen’s Amjevita® first to be released, followed by several others according to the schedule we first published in May 2019.
WHICH COMPANIES HAVE SIGNED LICENSING DEALS WITH ABBVIE?
|Company/Partner||Drug Name||Launch Date|
|Samsung Bioepis/Merck||Hadlima*||June 2023|
|Boehringer Ingelheim||Cytelzo*||July 2023|
|Mylan/Fujifilm Kyowa Kirin Biologics||Hulio*||August 2023|
|Fresenius Kabi||MSB11022||September 2023|
|*Received FDA Approval.|
A few developments have occurred since then, primarily the subsequent FDA approval of Hulio®, Hadlima®, and Abrilada®. Momenta was acquired by Johnson & Johnson in October 2020 and is no longer a separate entity or operating in the biosimilar business. But Coherus filed for approval in December 2020, and Alvotech and its partner Teva filed in November 2020. Celltrion, which completed its phase 3 trial, is on the verge of filing for approval, and Fresenius Kabi may join the crowd in filing this year as well.
The more interesting question is how these products might be differentiated. First, there are two concentrations: Two agents (Celltrion’s CT-P17 and Alvotech’s) will be available at the 100-mg/mL dose (which is a dosage offered by AbbVie’s Humira®), while the others will be dispensed at the 50-mg/mL dose.
Second is the availability or importance of a citrate-free formulation. The citrate-free formulation of Humira® is supposed to be associated with less injection-site pain, at least according to anecdotal evidence, but the value of this formulation has not been proven in clinical trials. Some of the planned biosimilars, such as Amjevita and Hulio, are citrate free. Other biosimilar manufacturers may roll out citrate-free adalimumabs, but this may not have a strong effect on payer coverage decision-making. Jeffrey Casberg, MS, RPh, Vice President, Pharmacy, IPD Analytics, believes that payers could ask patients to make a trade-off based on cost sharing: Would they pay more for a citrate-free version, if the preferred product is at a lower copay?
Third is the issue that has been looming for a couple of years now—the potential for Boehringer Ingelheim to score interchangeability status for Cyltezo®, which would be unique among adalimumab biosimilars. Boehringer Ingelheim cannot launch until July 2023, making it the third scheduled biosimilar to market. This will hurt whatever leverage Boehringer may have as the sole adalimumab interchangeable biosimilar. For example, should Amgen seal its payer contracts prior to January 2023, Boehringer will have to offer serious discounts just to get its foot in the door for the 2024 contract year. Mr. Casberg suspects that, in the end, Cytelzo won’t be the first biosimilar to be dubbed interchangeable; he thinks one of the insulins may be more likely to earn that distinction.
At this point, neither Celltrion nor Alvotech/Teva has signed licensing agreements with AbbVie. This raises an intriguing scenario. According to Mr. Casberg and the IPD Analytics team, “There is a possibility that these two agents could launch as early as late summer or fall of 2022.” Mr. Casberg told BR&R, “This is based on an assessment of publicly available information by IPD’s intellectual property group.”
Mr. Casberg emphasized, “I’m not saying that a 2022 launch is likely to occur, but that it could occur.” If this should occur, it could seriously upset the adalimumab settlement apple cart. If Celltrion or Alvotech decided to start marketing early, it may be launching at risk—but that’s a risk that might yield riches for a biosimilar maker emboldened by the prospect of a major cut of $16 billion in sales. If we have learned anything about the biosimilar market, it is that the first to launch has a big advantage over the others.