- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Bio-Thera Solutions Files for EU Bevacizumab Approval
This marks the first time a Chinese company has filed application for marketing of a biosimilar outside of China. Bio-Thera of Guangzhou, China, said a US application is pending.
Bio-Thera Solutions of Guangzhou, China, has filed a marketing authorization application to the European Medicines Agency for approval of BAT1706, an investigational biosimilar candidate that references Avastin.
The company said it hopes to obtain authorization for all indications of the reference product in the European Union, Iceland, Norway, and Leichtenstein.
The application marks the first "ex-China" application for biosimilar approval, or approval application for a drug developed in China for marketing abroad.
"Bio-Thera intends to bring its pipeline of biosimilars and innovative therapies to patients around the world and this submission is an important step for extending the global reach of BAT1706," said Shengfeng Li, founder and CEO.
Bevacizumab targets vascular endothelial growth factor (VEGF) by blocking the binding of VEGF to its receptor and thereby reducing vascularization that supports the development of tumors.
The reference product is approved in Europe for colon and rectum cancer; metastatic breast cancer; non–small cell lung cancer; renal cell caner; epithelial ovarian, fallopian tube, and primary peritoneal cancer; and cervical cancer.
Bio-Thera also intends to seek regulatory approval in the United States, and a biologics license application filing is anticipated before the end of 2020, the company said.
The company has one already marketed biosimilar, Qletli, an adalimumab biosimilar, which has been authorized for distribution in China.
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.
Review Confirms Clinical Safety of Sandoz Denosumab Biosimilar vs Originator
December 11th 2024Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
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.
Switching to Rituximab Biosimilars Is Safe, Effective for Patients With Oncohematological Diseases
December 5th 2024Patients with oncohematological diseases switching to rituximab biosimilars experienced similar safety and efficacy, highlighting biosimilars' potential for cost-effective treatment across various medical conditions.
