Finally, a firm date to fix on for Humira biosimilars in the US: January 31, 2023. This is when Amgen will launch Amjevita, its adalimumab biosimilar that the FDA approved last September, according to a deal hammered out between Amgen and Abbvie today.
The date is slightly later than many had expected – 2022 was thought to be on the cards – hence the 7% jump in Abbvie’s share price this morning, adding almost $10bn in market value. With Humira forecast to be raking in $15bn in revenues that year, even an extra month of sales will be hugely profitable for the US pharma giant.
A greater degree of certainty is also no doubt comforting investors. Despite Abbvie’s very successful defence of its patent suite, there was always a chance that biosimilar makers would reach the market sooner.
In Europe a launch date of October 16, 2018, has been set; Amgen is already expected to be one of at least six manufacturers launching on the continent at this time, when the main patent expires.
|Late-stage Humira biosimilars|
|Product||Company||US status||Europe status||Global 2022 sales ($m)|
|FKB327||Fujifilm Kyowa Kirin Biologics||Phase III||Filed||-|
|ONS-3010||Oncobiologics||Phase III||Phase III||222|
|PF-06410293||Pfizer||Phase III||Phase III||188|
|Adalimumab||Mylan/Biocon||Phase III||Phase III||134|
|M923||Momenta Pharmaceuticals||Phase III||Phase III||63|
|CHS-1420||Coherus Biosciences||Phase III||Phase III||-|
|MSB11022||Merck KGaA||Phase III||Phase III||-|
The deal comes at a cost to Amgen that is currently unclear. The group has agreed to pay undisclosed royalties on sales of its Humira version, and though further terms were undisclosed an up-front payment was surely involved.
Umer Raffat at Evercore ISI notes that it is also unclear whether Amgen has ensured certain volume share upon launch, or whether it has bought itself any lead time over additional settlements.
These are surely down the road, and will help determine how valuable this move is to Amgen. The huge commercial success of Humira has made it an equally huge target for biosimilars makers. There are 11 projects in late-stage development or in front of regulators, more than against any other biological.
Boehringher Ingelheim remains one to watch – not only is it close behind with US approval for Cyltezo in the bag, it is also running an interchangeability trial in psoriasis. The study should be completed in early 2019 – Bernstein analysts commented recently that this is the first bona-fide interchangeability trial on a MAb that they are aware of.
It is highly unlikely that any of these competitors will be willing to launch at risk, or be able to negotiate an even better deal. This means that Amgen has just secured itself the biosimilar launch that all have been chasing.