While the pembrolizumab copy was eye-catching, the firm’s next big biosimilar launch in Europe is a version of Roche’s Herceptin (trastuzumab). Biosimilar companies are poised to launch ...

Biosimilars offer clinically effective treatment ... the breast cancer biologic Herceptin (trastuzumab) and Avastin (bevacizumab) indicated for non-small cell lung cancer. Though it has sometimes ...

When Merck launched Ontruzant last April, the trastuzumab market became the most competitive to date with five biosimilars competing against the reference product. Pegfilgrastim and Infliximab ...

The primary analysis of KATHERINE, a phase 3, open-label trial, showed that the risk of invasive breast cancer or death was 50% lower with adjuvant trastuzumab emtansine (T-DM1) than with ...

Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for ...

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

Another important thing is biosimilars. So trastuzumab was first approved in 1998. And recently, in over the last five years, biosimilars have been approved. And they're all FDA approved.

In the HER2-low population, treatment with trastuzumab deruxtecan reduced the risk of disease progression or death by 38% compared with chemotherapy. The Food and Drug Administration (FDA ...

In patients with high-risk HER2-positive breast cancer, post-surgery, or adjuvant, treatment with trastuzumab emtansine (T-DM1) reduced the long-term risk of death or invasive disease by 46% and ...