Biosimilars
Page 1 • 12 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.
Biosimilar Regulation Japan: Aligning PMDA with EMA and FDA Guidelines
This article examines Japan's biosimilar regulations, focusing on how the PMDA aligns with EMA and FDA guidelines to enhance the approval process for drugs like infliximab.
Biosimilar Market in Japan: Growth Trends Post-PMDA Guideline Revisions
The biosimilar market in Japan is experiencing significant growth following PMDA guideline revisions, impacting drugs such as adalimumab for rheumatoid arthritis.
Biosimilars in Japan: Market Growth and PMDA Regulatory Insights 2024
This article delves into the expanding biosimilars market in Japan, focusing on trastuzumab's role in cancer treatment and the latest PMDA regulatory updates for 2024.
Biosimilar Landscape Japan: PMDA Regulatory Updates & Market Access 2024
Stay informed on Japan's biosimilar landscape with the latest PMDA regulatory updates and market access strategies for 2024, focusing on critical therapies like Adalimumab.
Biosimilar Landscape in Japan: Impact of PMDA Guideline Updates 2025
This article delves into the impact of the 2025 PMDA guideline updates on the biosimilar landscape in Japan, highlighting significant drugs and their indications.
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.
Biosimilar Market Growth Japan: Impact of PMDA's 2024 Regulatory Update
The PMDA's 2024 regulatory update is set to significantly influence the growth of the biosimilar market in Japan, particularly for drugs like adalimumab.
Biosimilar Landscape Japan: Impact of PMDA Updates & SAKIGAKE Designations
This article delves into the impact of recent PMDA updates and SAKIGAKE designations on the biosimilar market in Japan, particularly for Trastuzumab in breast cancer treatment.
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.