Clinical Trials
8
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1978
Completed
6
75.0%
Recruiting
2
25.0%
No approval data available
- Biocon Biologics received marketing approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for its pegfilgrastim biosimilar, a cancer supportive care medicine. - The product, a biosimilar to Neulasta, is designed to prevent infections following chemotherapy and will be exclusively promoted, sold, and distributed in Japan by Sandoz KK. - Global Regulatory Partners Japan serves as the marketing authorization holder on behalf of Biocon, with the product developed and manufactured by Biocon Biologics Ltd. - The approval strengthens Biocon's biosimilar portfolio in Japan and reaffirms its commitment to increasing global patient access to high-quality, affordable medications.
- Karnataka's 64th Vision Group on Biotechnology meeting, chaired by Kiran Mazumdar-Shaw, focused on embedding AI across the biotechnology value chain including drug discovery, diagnostics, and precision medicine. - Members emphasized the need for dedicated biotechnology investment mechanisms and stronger pathways for startups to access growth capital and scale globally. - The group identified AI-enabled biotechnology applications, biomanufacturing infrastructure expansion, and synthetic biology as key focus areas for the coming year. - Discussions highlighted Karnataka's potential to emerge as a global hub for AI-enabled biotechnology innovation, leveraging its strong research institutions and startup ecosystem.
- Biocon Biologics has launched Nepexto, a biosimilar to Enbrel (etanercept), in Australia through partnership with Generic Health to expand patient access. - Nepexto targets multiple autoimmune diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis. - The biosimilar has demonstrated broad adoption across Europe since receiving EU marketing authorization in 2020. - This launch represents part of Biocon Biologics' strategic global expansion following their 2022 acquisition and vertical integration of the biosimilars business.
- Biocon Biologics has received U.S. FDA approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Avastin, expanding its oncology portfolio to include a seventh FDA-approved biosimilar. - JOBEVNE, a VEGF inhibitor that restricts tumor blood supply, is indicated for multiple cancer types including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and several others. - The approval follows comprehensive comparative studies confirming JOBEVNE's similarity to Avastin, with U.S. bevacizumab sales reaching approximately $2 billion in 2023, representing a significant market opportunity.
