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.
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.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.