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 : CHMP Positive Opinion
Biosimilars
Mundipharma’s Pegfilgrastim Mundipharma (biosimilar, pegfilgrastim) Receives CHMP Positive Opinion for
Shots: The Mundipharma biosimilar Pegfilgrastim Mundipharma (6mg solution injection) will be authorized for sales in the EU to reduce the duration of neutropenia and the incidence of febrile neutropenia in […]readmore
Shots: The EMA’s CHMP has adopted the positive opinion for CT-P13 SC for its MAA which is based on P-I/III study assessing PK, safety & efficacy of CT-P13 SC vs […]readmore