Roundup: Coherus Resolves AbbVie Dispute; Bio-Thera Solutions and Celltrion Expand Respective Partnerships

Coherus Biosciences and AbbVie agree to resolve a dispute regarding Coherus’ partnership with the Mark Cuban Cost Plus Drug Company regarding its adalimumab biosimilar, and Celltrion Healthcare and Bio-Thera Solutions expand their respective partnerships to include more biosimilar products.

Coherus, AbbVie Dispute

According to a report from Reuters, Coherus Biosciences and AbbVie have agreed to resolve their dispute over Coherus’ new partnership with the Mark Cuban Cost Plus Drug Company to sell its adalimumab biosimilar, Yusimry, which references AbbVie’s Humira (reference adalimumab).

Cost Plus Drugs is an online pharmacy created by SharkTank’s Mark Cuban to offer generic drugs at significant discounts. Earlier in June, the pharmacy announced that it would partner with Coherus Biosciences to bring Yusimry to patients at $569.27 plus dispensing and shipping fees, marking the first time that Cost Plus Drugs has added a biosimilar to its list of prescriptions.

However, AbbVie alleged that the partnership infringed on a previous agreement between the company and Coherus that granted the latter a nonexclusive license to commercialize Yusimry in the United States beginning July 1, 2023. In response, Coherus filed a restraining order against AbbVie to keep it from terminating the licensing deal.

AbbVie followed by filing a preliminary injnction against Coherus. However, the companies have agreed to leave the licensing deal as is.

Adalimumab products are used to treat several immunology conditions, including rheumatoid arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, psoriatic arthritis, idiopathic arthritis, uveitis, and hidradenitis suppurativa.

Expanded Global Partnerships

Celltrion is expanding its partnership with Rani Therapeutics to develop RT-105, an orally administered adalimumab biosimilar. Under the new license and supply agreement, Celltrion will supply its biosimilar CT-P17 (Yuflyma) to develop RT-105 and Rani has the exclusive development and commercialization rights for the oral candidate. Following a phase 1 study, Celltrion will acquire the global rights to RT-105.

“We are pleased to build upon our existing partnership with Rani, a company that is pioneering oral drug delivery across a broad range of injectable therapeutics. The cooperation between our companies allows each of us to pursue our commitment to delivering effective and convenient medicines, which in time could benefit healthcare systems, providers and patients,” said SungHyun Kim, head of Celltrion’s medical science division.

The partnership builds on Rani’s oral delivery technology known as RaniPill capsule and is applying it to a tumor necrosis factor-alpha antibody, such as adalimumab, for the treatment of inflammatory diseases. The California-based company is also working on using the RaniPill capsule with an ustekinumab biosimilar (RT-111). The hope is that the technology can address the unmet need for oral biologic therapies.

Additionally, Bio-Thera Solutions expanded its partnership with Biomm in Brazil for the development and commercialization of BAT2206, an ustekinumab product referencing Stelara. Under the agreement, Biomm will have exclusive distribution and marketing rights to the biosimilar in Brazil.

The partnership was initiated around a licensing and supply agreement for Biomm to commercialize BAT1706, a bevacizumab biosimilar referencing Avastin, in Brazil.

Bio-Thera has completed a phase 1 study assessing the safety of BAT2206 and is currently conducting a phase 3 global trail evaluating the biosimilar compared to the reference product. Bio-Thera said that it intends to file for regulatory approval with the China National Medical Products Administration, the European Medicines Agency, and FDA, but Biomm will be responsible for filing the dossier in Brazil.

“Bio-Thera is pleased to expand our partnership with Biomm to commercialize our ustekinumab biosimilar program in Brazil…. By expanding our partnership with Biomm, Bio-Thera is doubling its commitment to providing Brazilian patients with increased access to important biotherapeutics at affordable prices,” said Shengfeng Li, PhD, CEO of Bio-Thera.