Today, Pfizer reported that their trastuzumab biosimilar to Roche’s Herceptin® has shown equivalence in a Phase 3 clinical trial measuring objective response rate (ORR) when taken in combination with paclitaxel to treat HER-positive metastatic breast cancer patients. Pfizer also reported success in a separate study, REFLECTIONS B3271004, evaluating this biosimilar in early…
According to The Korea Herald, the South Korean biopharma company Celltrion submitted their Herceptin biosimilar, Herzuma, to the European Medicine Agency for approval. Herzuma, a biosimilar to Roche’s breast cancer drug Herceptin (trastuzumab), was approved in Korea two years ago for the treatment of metastatic breast cancer, early stage breast…
A recent court ruling and a new publication on guidelines for biosimilars in India may offer further guidance on what biosimilar and biologic stakeholders can expect from Indian regulatory authorities. In late March, India’s Central Drugs Standard Control Organization (CDSCO) published Proposed Revised Guidelines on Similar Biologics (2016), offering guidance…