Tags : Etanercept

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 patients aged 4-17yrs. with JIA The clinical efficacy and safety studies conducted in patients with RA demonstrate clinical comparability between Brenzys and the reference product. […]Read More

Mylan and Lupin Receive EC’s MAA for Nepexto (biosimilar, etanercept)

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 psoriasis and pediatric plaque psoriasis The EC’s approval follows the CHMP’s positive opinion which is based on a biosimilarity assessment including preclinical and clinical studies […]Read More

Mylan and Lupin Receive CHMP’s Positive Opinion for Nepexton (biosimilar,

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, axSpA (including AS and nr-axSpA), PsO and pediatric PsO The positive opinion is based on bio similarity assessment which included pre/ clinical studies demonstrating bioequivalence […]Read More

Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial

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 for injection and can be self-administered by the patients, thus overwhelming the current Enbrel biosimilar which are available in lyophilized powder formulation in China Clover […]Read More