CDSCO Panel Approves Zydus Biosimilar for Breast Cancer
In News
What Happened
Why It Matters
Background
History & Context
What Changed
- ▶
BEFORE: Pertuzumab treatment relied exclusively on Roche's high-cost biologic drug, Perjeta. NOW: The regulatory progression of Zydus's biosimilar, Sigrima, paves the way for a significantly more affordable, domestically manufactured alternative.
- ▶
BEFORE: Sigrima faced clinical integrity accusations and a legal gridlock from Roche regarding patent infringement and reference drug sourcing. NOW: The December 2024 SEC approval allows Zydus to formally gather robust, long-term safety data through a Phase IV study, strengthening its clinical profile.
- ▶
BEFORE: High drug costs restricted many Indian patients from accessing the synergistic combination of pertuzumab and trastuzumab. NOW: An affordable biosimilar will eventually make this highly effective dual-antibody targeted therapy accessible to a broader demographic.
Prelims Angle
NCERT Connection
Practice Questions
Q1
Correct Statement(s)With reference to 'Sigrima' and targeted cancer therapies, which of the following statements is/are correct? 1. Sigrima is a recombinant humanized monoclonal antibody designed as an indigenous biosimilar to pertuzumab. 2. It specifically targets the HER2 receptor, a protein that is overexpressed in a significant proportion of breast cancer patients.