Blogs

China has now stepped into its “golden age” of biopharma; this year regulators approved the country’s first biosimilar product, HLX01.  Developed by Shanghai Henlius Biotech, it will be used primarily for treatment of non-Hodgkin’s lymphoma.  Biologics are sensitive large molecules, so selecting the appropriate packaging and delivery system is critical.  To this end, West Pharmaceutical Services, Inc. (“West”) recently held China BioPharma Summit for Injectable Drug Packaging and Delivery Systems in Suzhou.  Over 200 persons attended.

The new regulation “Bundling Review and Approval of Packaging and Excipients with Drug Products” announced by the China Federal Drug Administration (CFDA) on August 10, 2016, has generated both interest and concern. While the CFDA has published several related guidelines in an effort to address questions, many still persist.