Biosimilars
Page 1 • 11 itemsTrack global biosimilar approvals, market entry strategies, and regulatory pathways. Gain critical intelligence for your pharmaceutical BD and investment decisions.
Apotex Receives First Canadian Health Canada Approval for Generic Ozempic (Semaglutide) Alternative
Apotex becomes first Canadian pharmaceutical company to receive Health Canada approval for Apo-Semaglutide Injection, a generic equivalent of Ozempic.
EirGenix Expands Japan Biosimilar Strategy at CPHI Japan 2026 Amid Regulatory Support
EirGenix leverages Japan's supportive biosimilar regulatory framework and supply chain transformation to strengthen its strategic presence in the Japanese market.
Samsung Bioepis Begins Phase 1 Trial for Novel ADC SBE303, Expands Sandoz Biosimilar Partnership
Samsung Bioepis launches first-in-human trial for ADC candidate SBE303 and expands Sandoz partnership for five biosimilars including vedolizumab.
Mabwell Bioscience Passes First PIC/S Member GMP Inspection for Denosumab Biosimilars in Jordan
Mabwell Bioscience achieves milestone regulatory approval as Jordan FDA clears GMP inspection for two denosumab biosimilars, expanding global reach.
Mabwell Subsidiary T-mab Passes Jordan GMP Inspection for Denosumab Biosimilars
Mabwell's T-mab subsidiary receives GMP compliance approval from Jordan FDA for two denosumab biosimilars, marking regulatory milestone for bone treatments.
ICH Guidelines Biosimilar Development: Impact on APAC Approval Timelines
This article delves into ICH guidelines for biosimilar development, highlighting their influence on approval timelines in the APAC region for critical therapies.
Biosimilar Market Growth India: Key Drivers, Challenges & Opportunities
The biosimilar market in India is poised for significant growth, driven by increasing demand for affordable biologics like Trastuzumab, alongside various challenges and opportunities.
Adalimumab Biosimilars Uptake: Australia vs Japan Market Analysis
This article analyzes the market dynamics of Adalimumab biosimilars in Australia and Japan, highlighting differences in uptake and patient access for rheumatoid arthritis.
PMDA Biosimilar Framework: Impact on Trastuzumab Biosimilars in Japan
This article delves into the PMDA biosimilar framework and its significant influence on the development and approval of trastuzumab biosimilars in Japan.
NMPA Biosimilar Approval Pathway: What You Need to Know
Explore the NMPA biosimilar approval pathway for adalimumab, focusing on essential steps and requirements for gaining market access in China.
Bevacizumab Biosimilar Approval China: NMPA Greenlights First Biosimilar
The NMPA has approved the first biosimilar of Bevacizumab, a groundbreaking step for cancer treatment accessibility in China.