Drug Profile
Trastuzumab biosimilar - Prestige BioPharma
Alternative Names: HD 201; Hervelous; TuznueLatest Information Update: 22 Oct 2022
Price :
$50
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At a glance
- Originator Hanwha Biologics
- Developer Hanwha Biologics; Prestige BioPharma
- Class Antineoplastics; Immunotherapies; Monoclonal antibodies
- Mechanism of Action Antibody-dependent cell cytotoxicity; ERBB 2 receptor antagonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Preregistration Gastric cancer; HER2 positive breast cancer
- Phase I Breast cancer
- Preregistration Submission Withdrawal Oesophageal cancer
- No development reported Cancer
Most Recent Events
- 13 Oct 2022 Prestige Biopharma announces intention launch Trastuzumab biosimilar for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer in USA
- 13 Oct 2022 Prestige Biopharma announces intention to submit BLA to US FDA for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer in December 2022
- 13 Oct 2022 Prestige Biopharma announces intention to submit new MAA to the European Medicines Agency (EMA)