On 11 May 2022, Thailand FDA has approved Rituxikal (Rituximab Biosimilar). By this milestone, Innnogene Kalbiotech spread the wing not only to local market, but also to South East Asia market. Rituxikal has 2 strengths: Rituxikal 100 mg / 10 mL and Rituxikal 500 mg / 50 mL. Rituxikal is currently undergo technology transfer process to be produced in PT Kalbio Global Medika, Cikarang, Indonesia. PT Kalbio Global Medika (KGM) is a contract GMP biomanufacturing company specialized in the use of mammalian cells. KGM is also a part of Kalbe Group and subsidiary company of PT Kalbe Genexine Biologics (KGbio).
KGbio at a Glance
KGbio is a clinical-stage biotechnology company established in 2016, focused on bringing biologics medical innovation to markets outside the US/Canada, Western Europe and China. The business model revolves around in-licensing novel biologics and select biosimilars in oncology and high-specialty therapeutic areas (typically pre-IND or early clinical stage), with the objective to out-license them in target geographies after finishing clinical development as well as regulatory and reimbursement approvals.
Kalbio at a Glance
Kalbio Global Medika (KGM) is one of the first and the pioneer of biopharmaceuticals in Indonesia, established in 2014 and inaugurated officially in 2018 by the President of the Republic of Indonesia, Ir. Joko Widodo. KGM is part of PT Kalbe-Genexine Biologics (KGbio) Group, subsidiary of PT Kalbe Farma Tbk, which is a clinical-stage biotechnology company focused on bringing biologics medical innovation to markets outside US/Canada, Western Europe, and China. KGM is an Innovative CDMO, equipped with CMC and scale-up capabilities plugged into Boston biotech ecosystem and state-of-the-art facility to enhance efficiency and productivity. With API manufacturing, formulation, fill and finish capabilities of biosimilar and novel biologics, averaging 10 million units of syringes, cartridges, and vials, KGM supplies local and international markets.