Shots: The CHMP’s positive opinion is based on P-III DISCOVER-1 & -2 studies assessing guselkumab (100 mg, q4w/q8w) vs PBO in 381 & 739 patients with active PsA & patients […]readmore
Tags : PsA
Biosimilars
Biotech
Sandoz’s Erelzi (etanercept, biosimilar) Receives Health Canada Approval for Psoriatic
Shots: The approval is based on P-III EGALITY study results assessing Erelzi (etanercept) vs Enbrel, evaluating its PK, safety and efficacy On 17 Jan, 2019 Sandoz received NOC from Health […]readmore
Biosimilars
Regulatory
Sandoz’s Hymiroz (adalimumab-adaz) Receives the US FDA Approval for Treatment
Shots: The approval is based on the non-inferiority data demonstrating its biosimilarity in terms of PK, immunogenicity and safety meeting all 1Eps & results of ADACCESS study confirming its safety […]readmore