Coherus retracts AbbVie restraining order in Humira biosimilar dispute

Biosimilars/General | Posted 11/08/2023 post-comment0 Post your comment

Coherus BioSciences agreed to retract its restraining order against AbbVie in June 2023, an action taken to prevent AbbVie from terminating its Humira licence deal [1].

Adalimumab V13F21

In 2019, the two companies signed a settlement that would give Coherus the global non-exclusive licence rights to commercialize its Humira (adalimumab) biosimilar (CHS-1420/Yusimry) and pay royalties to AbbVie, the producer of the originator/reference product.

However, AbbVie alleged a breach of this agreement as Coherus announced it would launch its biosimilar version of AbbVie's Humira, at an 85% discount to the list price of about US$6,922 and will sell it at US$569.27 (plus shipping and fees). Coherus has partnered with Mark Cuban Cost Plus Drug Company to facilitate the low-price sales. Following US approval in 2021 [2], the biosimilar is set to launch in July 2023 and will be the lowest priced adalimumab product available in the US with a list price of US$995 per carton (2 x 40 mg/0.8 mL autoinjectors) [3]. 

In response, Coherus filed a restraining order against AbbVie to keep it from terminating the 2019 licensing deal. This was followed by a preliminary injunction against Coherus, which remains in place. However, the companies have now agreed that AbbVie would not terminate its licensing deal based on the notice and as such, the restraining order has been retracted.

Adalimumab, sold under the brand name Humira, is the monoclonal antibody used to treat a range of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis and inflammatory bowel disease (IBD) [4, 5]. Since first launching in the US in 2003, Humira® as a product has evolved in many ways including new concentrations, citrate-free versions, latex-free delivery devices, and smaller needle gauges [6]. 

Coherus’ biosimilar, Yusimry has a state-of-the-art autoinjector presentation and includes Coherus’ proprietary non-stinging, citrate-free formulation and a 29-gauge needle. It is also proposed that Yusimry will be included in the Team Cuban Card prescription benefit programme through participating pharmacies. This card provides patients the flexibility to get prescriptions filled at a local independent pharmacy at the same low prices they expect from Cost Plus Drugs. It also supports the independent pharmacy community with fair dispensing fees and a transparent pricing structure.

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References
1. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Coherus sign licensing deal for Humira biosimilar  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 11]. Available from: www.gabionline.net/pharma-news/AbbVie-and-Coherus-sign-licensing-deal-for-Humira-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 11]. Available from:
www.gabionline.net/biosimilars/news/fda-approves-adalimumab-and-insulin-glargine-biosimilars-yusimry-and-rezvoglar
3. GaBI Online - Generics and Biosimilars Initiative. Coherus: lowest price adalimumab biosimilars announced  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 11]. Available from: www.gabionline.net/biosimilars/news/coherus-lowest-price-adalimumab-biosimilars-announced
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 11]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
5. GaBI Online - Generics and Biosimilars Initiative. Switching from adalimumab originator and ABP501 to SB5 in arthritis patients  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 11]. Available from:
www.gabionline.net/biosimilars/research/switching-from-adalimumab-originator-and-abp501-to-sb5-in-arthritis-patients
6. GaBI Online - Generics and Biosimilars Initiative. Humira (adalimumab) biosimilars pipeline  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 11]. Available from:
www.gabionline.net/reports/humira-adalimumab-biosimilars-pipeline

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