Biopharmaceuticals were the hottest thing this year with a string of new drug launches, trial results and related news that made the concept more than just a futuristic concept and gathered interests from more than only investors.
According to the Ministry of Food and Drug Safety, the biopharmaceutical market was worth around 1.8 trillion won ($1.66 billion) this year, representing an 11.6 percent jump from last year. Biopharmaceutical exports surpassed 1 trillion won, hitting a new high. While the number of clinical trials for synthetic drugs fell by 14 percent, those for biopharmaceutical products rose 12 percent. Data showed 226 out of 628 clinical trials in 2016 were for developing bio-products. The increasing number of clinical trials for biopharmaceuticals is showing no signs of letting up.
Industry-wide changes also signaled a shift from synthetic medicines to biological ones. The food-drug safety ministry set up a bio department to take on related administrative tasks. Members of the Korean Pharmaceuticals Manufacturing Association added the word “Bio” to the association, comprised of various domestic pharma firms.
The Korean biopharmaceutical market is driven forward by Celltrion, Samsung Bioepis, and Samsung Biologics. Samsung Bioepis secured its position as a market leader with the most biosimilar approvals while Celltrion shook up the industry after jumping into biobetters development. Biobetters are altered products of biologics that are deliberately changed to improve the original.
Samsung Bioepis secured its fourth regulatory approval with Samfenet, following getting the go-ahead for SB5 (original: Humira), Renflexis (original: Remicade), and Brensys (original: Enbrel).
Celltrion is developing biosimilars for Roche’s Avastin, MedImmune’s Synagis, AbbVie’s Humira, and Merck & Co’s Erbitux. It gained approval for the world’s first biosimilar Remsima (original: Remicade), along with Herzuma (original: Herceptin), and Truxima (original: Mabthera). Celltrion is now preparing biobetters for influenza, hepatitis B, breast cancer, and rabies.
SillaJen, the developer of immunotherapy PexaVec, came to the forefront of discussion with its market value exceeding 8 trillion won this year. Other up-and-coming developers included Invossa-developer TissueGene and the biopharmaceutical firm CANCER ROP (previously known as MGmed).
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