Shots: The P-III study evaluate the efficacy, safety & immunogenicity of BCD-021 (q3w for 6 cycles) vs Avastin + paclitaxel & carboplatin in 357 patients with stage IIIB or IV […]readmore
Shots: Pharmapark to get exclusive rights to commercialize the therapy with a status of a local product & will be responsible for filing the report in Russia and other CIS […]readmore
Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases The study showed […]readmore
Shots: The COLUMBUS-AMD trial evaluates the clinical efficacy, safety & immunogenicity of CHS-201 (q4w for up to 48wks.) vs Lucentis in a ratio (1:1) in 477 patients with newly diagnosed […]readmore
Shots: The US FDA has issued a notification to Polpharma Biologics for the acceptance of BQ201’s (biosimilar, ranibizumab) BLA to treat wet AMD with an anticipated PDUFA date in Aug’22 […]readmore
Shots: The US FDA has accepted the BLA for FYB201, a biosimilar referencing Lucentis for review and assigned a target action date for the application for Aug’2022 Following the approval, […]readmore
Shots: The US FDA has accepted the BLA under the 351(k) for CHS-201 (biosimilar, ranibizumab) with an anticipated BsUFA date is Aug 02, 2022 If approved, the company plans to […]readmore
Shots: Apobiologix expands its footprints in Canada with the approval of Bambevi + CT to treat colorectal, lung, brain and ovarian cancer The approval is coupled with well-established Apobiologix supportive […]readmore
Shots: The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study evaluates the efficacy, safety, PK & immunogenicity of SB11 (0.5mg) vs Lucentis […]readmore
Shots: The P-III study evaluates TX05 (biosimilar, trastuzumab) vs Herceptin in 809 patients with HER2-positive early-stage breast cancer The results showed that the proportions of patients that meet pCR criteria […]readmore
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