Shots: The US Supreme Court has denied Sandoz’ petition to review Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for the reference product, Enbrel (etanercept) The company […]readmore
Tags : Etanercept
Biosimilars
Regulatory
Merck’s Brenzys (etanercept, biosimilar) Receives Health Canada Approval for Multiple
Shots: Health Canada has approved Brenzys for new indications that include adults & pediatric patients (4-17yrs.) with PsO who are candidates for systemic therapy/ phototherapy, adult patients with PsA, and […]readmore
Shots: The companies launch Nepexto, a biosimilar referencing Amgen’s Enbrel, and is indicated for the mod. to sev. RA, JIA from the age of 2yrs., active and progressive PsA, severe […]readmore
Shots: The EC has granted MAA for Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including axSpA and nr-axSpA), plaque […]readmore
Shots: The EMA’s CHMP has adopted a positive opinion recommending the approval of Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, […]readmore
Shots: The P-III study involves assessing of SCB-808 vs Enbrel in patients with AS (axSpA) via SC administration SCB-808 is being developed in the prefilled syringe formulation which is ready […]readmore
Shots: The study enrolled BADBIR-registered patient treated with Benepali from Jan 01, 2016 to Sept 01, 2018. BADBIR is a UK and Ireland observational study assessing long-term safety of biologic […]readmore
Shots: Samsung Bioepis reports the expansion of its global business with the entry of its first product, Brenzys (etanercept) in Brazil through Brazil’s public health system, Sistema Único de Saúde […]readmore
Shots: The approval is based on global P-III trial results assessing etanercept biosimilar (YLB113) vs Enbrel in 500 patients with RA across 11 countries including Japan, EU and India, evaluating […]readmore
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