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Bio-Thera Solutions Gets Clearance to Start Phase 1 Trial of Ustekinumab Biosimilar
Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, said this week that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a phase 1 clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar, to the reference Stelara in healthy volunteers.
Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, said this week that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a phase 1 clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar, to the reference Stelara in healthy volunteers.
The clinical study will be a randomized, double-blind, parallel group, single-dose study that is expected to enroll approximately 270 people. The study will use US-sourced and EU-sourced reference products.
Bio-Thera joins other companies seeking to develop ustekinumab biosimilars, including Formycon (which is developing FYB202) and NeuClone.
“This IND approval represents an important milestone for our biosimilar pipeline,” said Shengfeng Li, chief executive office of Bio-Thera Solutions, in a statement. “BAT2206 will be the fifth biosimilar that Bio-Thera will advance into clinical development. It signifies Bio-Thera’s continued commitment to developing and commercializing biosimilar products for patients in China and around the world.”
In the United States, ustekinumab, a human interleukin-12 and -23 antagonist, is approved by the FDA to treat plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.
Bio-Thera Solutions is developing several additional biosimilar products, including Qleti, a biosimilar to reference adalimumab (Humira) that was recently approved in China; it is also evaluating BAT1706, a bevacizumab biosimilar to Avastin, in a global phase 3 clinical trial.
Bio-Thera Solutions is also pursuing biosimilar versions of tocilizumab (Actemra), secukinumab (Cosentyx), and golimumab (Simponi).
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
Ocrelizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment
November 26th 2024The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.
