Mylan & Biocon Receive CHMP Recommendation to Ogivri (trastuzumab, biosimilar) for HER-2 Breast Cancer

Shots:

• The CHMP recommendation will be reviewed by EU with expected closure in H2’18. In 2017, FDA approved Ogivri a novel biosimilar to Herceptin with additional regulatory approval in 35 countries
• The regulatory approval is based on the non-inferiority data collected from P-III Heritage study results with no difference in safety, efficacy & immunogenicity b/w Herceptin and Ogivri
• Mylan & Biocon globally collaborated to co-develop Ogivri, indicated in patients with HER-2 positive EBC, mBC & mGC. In July 2018, Herceptin had brand sales of ~ $1.9B in EU

Click here to read full press release/ article | Ref: Mylan | Image: Gurumavin