Shots: The P-I study assesses the PK, safety, tolerability and immunogenicity of SB17 vs Stelara (US & EU sourced) in 201 healthy males in a ratio (1:1:1) aged 18-55yrs. All […]readmore
Tags : Proposed
Shots: The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. The anticipated […]readmore
Shots: Genentech filed a complaint in the Eastern District of Texas alleging that the proposed biosimilar to Avastin (bevacizumab) product infringes 10 US patents Genentech alleges that Centus and partners […]readmore
Shots: The P-III study involves assessing SB11 vs reference ranibizumab in monthly injections (0.5 mg) in 705 patients in a ratio (1:1) with nAMD while only 634 patients continued to […]readmore
The submission of the application and labelling for proposed biosimilar or proposed interchangeable biosimilar for fewer than all the reference product’s licensed condition of use The submission of supplement to […]readmore