This symposium will devote two days to discuss: 1. Discussion with expert for the guideline of mAb biosimilars and Chinese Pharmacopoeia; 2. key technical challenges for biosimilar and novel biologics development in China; 3. clinical and regulatory considerations and case studies for biosimilar development.
The global biopharmaceutical industry continues to expand rapidly in recent years, which has created unprecedented development opportunities for the biopharmaceutical industry in China. As multiple blockbuster biologics soon lose patent protection, the Chinese biopharmaceutical industry is taking advantage of the low hanging fruits of the “patent cliff” by joining forces in R&D to develop and commercialize high quality, low cost bio-similars for the Chinese market. Upon establishing the core platform technologies for biopharmaceutical development in China, the biopharmaceutical industry is also strategically transform from biosimilar development to innovative biologics by moving into novel molecules and new targets. Due to the immense market potential for biologics in China, many global biopharmaceutical companies have already taken China as a key future market for biologics through steady growth of co-development and technology transfer. The regulatory authorities in China are also catching up on biosimilar development guidelines with international regulations. However, how to capitalize on this unprecendented opportunity in China remains a unique challenge from both regulatory and technical perspectives.
Who Should Attend:
The decision makers at senior and middle management levels, the technical leaders and scientific staff responsible for biologics development in R&D, Regulatory Affairs, Clinical Development, Process Development, Analytical Development, Biologics Manufacturing, and QA&QC.