This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
SmartTrack aims to reduce the need for clinical studies in generic drug product approvals
Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara
YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis
Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025
Innovative chronic pain treatment receives IP protection in India's $55 billion pharmaceutical market
Subscribe To Our Newsletter & Stay Updated
