Trastuzumab biosimilar - Hanwha BiologicsAlternative Names: HD 201
Latest Information Update: 13 Jan 2017
At a glance
- Originator Hanwha Biologics
- Class Antineoplastics; Monoclonal antibodies
- Mechanism of Action ERBB 2 receptor antagonists; Immunomodulators
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
On Fast track
Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.
- New Molecular Entity No
Highest Development Phases
- Phase I Cancer
Most Recent Events
- 13 Jan 2017 Prestige Biopharma plans a phase III trial for Breast cancer (Inoperable/unresectable, Combination therapy, Late-stage disease) in Ukraine, Belarus, Bulgaria, Estonia, Hong Kong, Latvia, Lithuania, Malaysia, Philippines, Russia, Singapore, Slovenia, Thailand, Slovakia (NCT03013504)
- 30 May 2013 Biomarkers information updated