Tags : HER-2 B

Biosimilars Regulatory

Mylan & Biocon Receive CHMP Recommendation to Ogivri (trastuzumab, biosimilar)

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 […]Read More