Biosimilar Business News Recap: Mepolizumab Study; New Licensing Deal; Hukyndra Launches in Switzerland

Bio-Thera Solutions began a phase 1 trial for its mepolizumab biosimilar candidate; Biocon Biologics licenses out 2 biosimilars to Yoshindo; and Alvotech and STADA Arzneimittel launch Hukyndra, an adalimumab biosimilar, in Switzerland.

Testing for Mepolizumab Biosimilar Begins

Bio-Thera Solutions began a phase 1 study for a biosimilar candidate referencing Nucala (mepolizumab). The study would assess the pharmacokinetics and safety of the biosimilar (BAT2606) in healthy participants.

The randomized, double-blind, parallel group, single-dose study will include 207 healthy volunteers. Mepolizumab is an interleukin 5 antagonist monoclonal antibody that can be administered subcutaneously with a syringe or autoinjector device. Nucala is used to treat:

• Adult and pediatric patients 6 years and older with severe asthma or an eosinophilic phenotype as an add-on maintenance therapy
• Adult patients with chronic rhinosinusitis with nasal polyps as an add-on maintenance therapy
• Adult patients with eosinophilic granulomatosis with polyangiitis
• Adult and pediatric patients 12 years and older with hypereosinophilic syndrome for at least 6 months without a nonhematologic secondary cause

After the study is completed, Bio-Thera will conduct a global phase 3 study. The company said that it plans to apply for regulatory approval in the United States, China, the European Union, and other markets around the world.

Biocon Biologics Licenses Out to Yoshindo

Biocon Biologics entered into a licensing agreement with Yoshindo for the Japanese commercialization of 2 biosimilar candidates: an ustekinumab biosimilar and a denosumab biosimilar.

Under the deal’s terms, Yoshindo would have exclusive commercialization rights for the biosimilars in Japan in exchange for $700 million. Biocon Biologics would receive an upfront license fee along with additional payments dependent on the achievement of development milestones over the next few years. The companies did not disclose the exact financial terms of the deal.

The ustekinumab biosimilar references Stelara and will be used to treat autoimmune conditions including, psoriasis, Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The denosumab candidate references Prolia and is used to treat patients with osteoporosis and patients undergoing cancer treatments who are at a high risk of fracture. Phase 1 and phase 3 clinical trials for the biosimilars began in 2022.

“Once approved, these products will expand our offering of affordable, high quality biosimilars in the Japanese market and help address unmet patient needs in bone health and immunology therapy areas,” said Shreehas Tambe, deputy CEO of Biocon Biologics, in a statement.

Hukyndra Launches in Switzerland

Alvotech and STADA Arzneimittel announced that they launched Hukyndra, an adalimumab biosimilar referencing Humira, in Switzerland. Hukyndra launched as a high-concentration, low-volume, citrate-free formulation.

“Significant unmet needs for access to biologics exist for patients across Europe…. Our partnership with Alvotech enables STADA to deliver a broad range of high-quality biosimilars to European patients. Launches of Hukyndra in multiple markets is evidence of our commitment to broader access to critical therapies,” said Bryan Kim, head of global specialty and executive vice president of STADA.

STADA and Alvotech entered into their partnership in November 2019. The agreement includes 7 biosimilars, including Hukyndra. Alvotech is responsible for development and manufacturing and STADA is in charge of commercialization. In Switzerland, Hukyndra is being marketed by Spirig HealthCare, a subsidiary of STADA. The biosimilar will be made available in 80 mg/0.8mL and 40 mg/0.4 mL syringes for self-administration and 40 mg/0.4 mL prefilled autoinjector pens.

The European Medicines Agency granted Hukyndra marketing authorization in November 2021. In addition to Switzerland, Hukyndra is available in Austria, Estonia, France, Finland, Germany, Lithuania, Slovakia, and Sweden. The biosimilar has also been approved in the United Kingdom and is under review in the United States.