On September 20th, the Adalimumab injection biosimilar developed by Bioray Pharmaceutical (Hangzhou) Co., Ltd., a subsidiary of Zhejiang BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as “BioRay”), successfully passed the GMP inspection by Colombia’s National Institution for Medications and  Food Surveillance (INVIMA). This marks another solid step for BioRay on its path to globalization with the company's quality management system once again receiving international recognition for its compliance and standardization.

No critical deficiencies were identified during the audit, and all corrective actions for any other issues were promptly conducted which led to the 'Compliance' conclusion on the last day of the audit.

Colombia is a major country in South America with growing medical needs. Adalimumab injection, a fully human monoclonal antibody against tumor necrosis factor-α (TNF-α), is widely used globally to treat various autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, and psoriasis.

Passing INVIMA’s GMP on-site inspection not only proves the reliability of the adalimumab injection’s quality but also provides an important pass for the product to enter the Colombian market. This will also promote the product’s access to other major markets in South America.