Tags : (ustekinumab)

Bio-Thera Initiates P-I Study of BAT2206 Proposed Biosimilar to Stelara

Shots: The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206, a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product in healthy volunteers The company is expected to enroll 270 healthy volunteers. BAT2206 represents the fifth biosimilar of Bio-Thera’s portfolio that has advanced into clinical […]Read More

Janssen Receives EC’s Approval for the Expanded Use of Stelara

Shots: The EC’s approval is based on P-III CADMUS Jr study assessing Stelara (SC) in 44 pediatric patients with mod. to sev. PsO aged 6–11 yrs. from 9 countries. The study follows its prior P-III CADMUS study The P-III CADMUS Jr study results: @12wks. improvement in psoriasis and HrQOL; patients achieved PGA 0/1 (77.3%); PASI […]Read More

Meiji and Dong-A Socio Initiate P-I Trial for DMB-3115 (biosimilar,

Shots: The P-I trial involves assessing of DMB-3115 vs reference products (US- and EU-marketed products under the name of Stelara) in healthy volunteers to evaluate its safety, PK and tolerability in Europe In 2011, Meiji and Dong-A signed a joint venture agreement on biosimilars to build DM Bio Limited in Incheon Free Economic Zone and […]Read More

Bio-Thera Reports NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar

Shots: Bio-Thera to initiate P-I study to evaluate the PK and safety study of BAT2206 (proposed biosimilar) vs Janssen’s Stelara (ustekinumab) US & EU-sourced in normal healthy candidates The clinical study will enroll ~ 270 healthy volunteers. The initiation of the study implies Bio-Thera’s commitment to develop & commercialize biosimilars for patients across the globe […]Read More

NeuClone Reports Dosing of NeuLara (proposed biosimilar, ustekinumab) in P-I

Shots: Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme is responsible for conducting the NeuLara P-I trial and is being conducted across 200 healthy volunteers assessing PK and safety of US- and EU-sourced Stelara NeuClone’s NeuLara is the second biosimilar in pipeline to enter in clinical development and is developed in partnership with […]Read More

Janssen’s Stelara (ustekinumab) Receives EC’s Approval for its Expanded Use

Shots: The EC approval is based on P-III UNIFI program [induction study (8wks. IV) & maintenance study (44wks., SC, q8w & q12w)] assessing Stelara vs PBO in patients with mod. to sev. active UC with inadequate response to conventional (corticosteroids, immunomodulators) or biologic (one or more TNF-alpha antagonists/vedolizumab) therapies Induction study results: Clinical response achievement […]Read More