Eye on Pharma: New Partnerships; Samsung Adalimumab Updates; Phase 3 Ustekinumab Results

Alteogen and Alvotech announce updates for their respective license partnerships; Samsung Bioepis speeds up interchangeability study for its adalimumab biosimilar; Dong-A ST shares positive phase 3 results for its ustekinumab biosimilar.

New Licensing Agreements for Alteogen, Alvotech

Daejeon, Republic of Korea–based Alteogen entered into an exclusive license agreement with Sandoz to develop and commercialize a subcutaneous version of a Sandoz biosimilar products using Alteogen’s Hybrozyme Technology. The agreement also includes an option to license the technology for 2 further products.

Alteogen will receive upfront payments and milestone payments as Sandoz meets specified development, regulatory, and sales milestones. Alteogen will also receive tiered royalty payments for sales of the commercialized product. The products included in the deal were not disclosed publicly.

Additionally, Alvotech expanded its partnership with Fuji Pharma, granting the latter the commercialization rights to an undisclosed biosimilar candidate in Japan. The companies have been in an exclusive partnership agreement since November 2018.

Samsung Bioepis Provides Updates on Adalimumab Biosimilar

Samsung Bioepis disclosed that it received domestic product licensing for its adalimumab biosimilar referencing Humira in the Republic of Korea, according to Korea Biomedical Review. The biosimilar was approved as a prefilled syringe (40 mg/0.4 mL) and an auto-injector pen (40 mg/0.4 mL) and will be marketed under the name Adalloce. The product is a high-concentration, citrate-free formulation.

Adalloce will be used to treat patients with rheumatoid arthritis, psoriatic arthritis, axial spinal arthritis, Crohn disease, psoriasis, ulcerative colitis, Becchett enteritis, purulent hives, and nephritis in adults, and Crohn disease, idiopathic arthritis, and plate dryness in pediatric patients.

In addition, the Korea Herald reported that Samsung Bioepis is speeding up the processes for obtaining an interchangeability designation for Adalloce in the United States, where it will be marketed as Hadlima when it enters the US market in July 2023.

The company originally planned to complete the study needed to obtain the designation by September 2023. However, it will now aim to finish the study in May 2023. When Hadlima launches, the biosimilar will not have an interchangeable label and it will be marketed by Samsung Bioepis’ US licensing partner Organon.

Dong-A ST Shares Phase 3 Ustekinumab Results

Dong-A ST, a company based in the Republic of Korea, announced that a phase 3 therapeutic equivalence study demonstrated that the company’s ustekinumab biosimilar (DMB-3115) has similar safety and efficacy profiles to the reference product (Stelara), according to a report from Korea Biomedical Review.

Ustekinumab products are used to treat inflammatory diseases, including Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Stelara is one of the highest-grossing biologic drugs in the world, accumulating $16.8 billion in global sales during the third quarter of 2022.

The phase 3 study conducted in 2021 in the United States and 9 other countries, such as Poland, Estonia, and Latvia. The study included 605 participants with moderate to severe chronic plaque psoriasis and evaluated the safety, efficacy, and immunogenicity of DMB-3115 over 52 weeks.

DMB-3115 has been jointly developed by Dong-A Socio Holding and Meiji Seika Pharma since 2013. Dong-A ST received the commercialization and development rights to the biosimilar in July 2020.