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Bio-Thera, a Guangzhou biotech, was approved by China's National Medical Products Administration to start a Phase I trial that compares its Stelara® biosimilar to the original. Johnson & Johnson's Stelara is indicated to treat immune disorders including Crohn's disease, ulcerative colitis and psoriasis conditions. The China trial, which will test the pharmacokinetics and safety of Bio-Thera's BAT2206, will enroll about 270 healthy volunteers. BAT2206 will be the fifth Bio-Thera biosimilar to begin clinical trials. More details....
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Biotechnology - Biotech
"using living things to create products or to do tasks for humans" About Biotechnology - Biotech Biotechnology is the practice of using plants, animals and micro-organisms such as bacteria, as well as biological processes - such as the ripen...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Products that ar...