- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Bio-Thera Solutions' Biosimilar Adalimumab Launches in China
It is the first adalimumab biosimilar approved by the China National Medical Products Administration.
Bio-Thera Solutions said Friday that Qleti, a biosimilar adalimumab referencing Humira, is now available in China.
It is the first adalimumab biosimilar approved by the China National Medical Products Administration (NMPA) and is authorized for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.
Bio-Thera's said it is the first of its biosimilars to receive regulatory approval and is the second biosimilar approved in China by the NMPA.
Bio-Thera announced in July 2019 that the biosimilar, BAT1406, had met its primary end point of equivalent efficacy to reference adalimumab in a phase 3 trial conducted in patients with active ankylosing spondylitis.
The application submitted to the regulatory authorities included a comprehensive data package that consists of analytical, preclinical, and clinical data. The clinical studies included a trial that investigated pharmacokinetic and pharmacodynamic data, as well as the phase 3 study in AS.
The drug maker is also developing biosimilar candidates of bevacizumab, tocilizumab, ustekinumab, and golimumab.
“The commercial launch of Bio-Thera’s first approved product is an enormous milestone for the company," said Shengfeng Li, PhD, chief executive officer of Bio-Thera Solutions, in a statement. "It demonstrates that Bio-Thera Solutions is a fully-integrated pharmaceutical company, able to take a product developed in our labs, through the clinic, through regulatory approval and now to the market. Bio-Thera is committed to bringing additional biosimilar and innovative products to the market in China and around the world."
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.
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?
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.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.
