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Eye on Pharma: Biosimilar Ozempic; Celltrion Omalizumab Biosimilar Submission
A Chinese company has expressed interest in developing a biosimilar to Ozempic (semaglutide); Celltrion completed its biologic license application for its omalizumab biosimilar candidate.
A Chinese company has expressed interest in developing a biosimilar to Ozempic (semaglutide), a popular drug used for diabetes and weight loss; Biocon and Mylan are in talks to merge their biosimilar businesses; Celltrion completed its biologic license application (BLA) for its omalizumab biosimilar candidate.
Biosimilar Ozempic on the Horizon?
A report from Reuters found that Chinese drugmaker Hangzhou Jiuyuan Gene Engineering is working on a biosimilar to Novo Nordisk’s semaglutide (Ozempic and Wegovy). Semaglutide has gained a lot of traction around the world in the past couple years, particularly in the US, as a popular treatment for type 2 diabetes and obesity.
The move could pose challenges to the originator manufacturer’s planned expansion into China as patents for Ozempic are not set to expire until 2026. Chinese sales of drug soared in 2023, reaching nearly $700 million; however, the demand is largely driven by people seeking weight loss.
Approval for Hangzhou Jiuyuan Gene Engineering's biosimilar, named Jiyoutai, would make it China's first locally developed biosimilar semaglutide drug. However, Novo Nordisk has expressed concerns about the impact of cheap copies of Ozempic on its business in China, emphasizing the importance of innovation protection to encourage the development of new medicines.
Hangzhou Jiuyuan Gene Engineering conducted a late-stage clinical trial comparing its semaglutide injection with Ozempic. Despite the potential launch of Jiyoutai, the company acknowledged that commercialization would depend on the outcome of Novo Nordisk's patent status on Ozempic.
In related news, Novo also faced challenges with Ozempic supply shortages in Europe, with starter kits unavailable in Germany during the second quarter.
Celltrion Omalizumab Biosimilar Submission
Celltrion USA announced the submission of a BLA for CT-P39, a biosimilar candidate to Xolair (omalizumab). The company is hoping to gain approval for the biosimilar as a treatment for moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU), IgE-mediated food allergy, and chronic rhinosinusitis with nasal polyps as well as an interchangeability designation.
The submission included data from a global phase 3 clinical trial assessing CT-P39's efficacy, safety, and pharmacokinetics compared with the reference product in patients with chronic spontaneous urticaria up to week 40.
According to Celltrion, Xolair achieved global market sales of $3.89 billion in 2022. In the US, the compound patent for the product has expired and patents protecting Xolair’s formulation are set to expire in November 2025.
The news comes after Celltrion launched Zymfentra (infliximab-dyyb) in the US as the first and only subcutaneous infliximab product.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
