WHO Pre-qualification is an internationally accepted certification standard for drugs (including vaccines). It provides technical support for the procurement of quality-assured medicines by international public health organizations such as United Nations agencies. For pharmaceutical companies, obtaining pre-certification is equivalent to obtaining market access passes for multiple public purchasers at one… Continue Reading WHO pre-certification is open for the first time on biopharmaceuticals and biosimilars

The Financial Times issued a statement last week saying that thanks to the Chinese government’s regulatory support and growing interest in the investment community, China BioPharma has ushered in a booming era and has attracted many global pharmaceutical industry executives, especially multinationals. Pharmaceutical company talents. On a global scale, many… Continue Reading Localization of six heavy biologic drugs in China

On June 4, the FDA approved the marketing of Mylan Fulphila (pegfilgrastim-jmdb) to reduce the risk of neutropenia infection and fever. Fulphila is the 10th biosimilar approved by the FDA and the first biosimilar of Amgen Neulasta (pegfilgrastim).   Amgen launched the world’s first recombinant human granulocyte colony-stimulating factor, Neupogen… Continue Reading The first bioanalogue of Amgen’s $4.5 billion product

According to IMS database statistics, the global generic pharmaceutical market reached 193 billion U.S. dollars in 2015, of which the total sales of generic drugs in the U.S. market was 71.9 billion U.S. dollars. It is estimated that in the next five years, the compound annual growth rate of the… Continue Reading Global generic drugs giant inventory (1) | Teva: Israeli Giant