Biosimilars are a lifeline for patients in need of affordable, life-changing biologic therapies for conditions such as cancer, autoimmune diseases, and diabetes—especially in countries like India, where the high cost of original biologics puts them out of reach for many. While the biosimilar industry is growing rapidly, significant barriers remain that prevent patients from receiving timely and affordable treatment. Unlike generic medicines, biosimilars often lead to only modest price reductions due to complex regulatory and market dynamics, meaning many patients still struggle to access the therapies they need.
Recent breakthroughs in analytical science now allow for more precise and comprehensive characterization of biosimilars, reducing the reliance on lengthy and costly animal and clinical studies. This scientific progress increases confidence in the safety and effectiveness of biosimilars, paving the way for faster development and approval. By embracing these modern, science-driven approaches, India has the opportunity to accelerate the production of high-quality biosimilars, streamline regulatory pathways, and ultimately deliver more affordable and accessible treatments to patients who need them most.
This public talk aims to bring patient advocates, civil society organizations working on access to medicines, academia and experts together to discuss how innovation and collaboration can transform access to biosimilars in India. In response to these global advancements, the Indian Regulatory body – (CDSCO) has brought out a new draft biosimilar guideline. The forum will focus on how the new guidelines will help to overcome local challenges—ensuring that patients benefit from the most up-to-date, safe, and affordable therapies.
Through collaborative efforts, access to safe, effective, and affordable biologic treatments can be ensured—turning scientific progress into real- world health benefits for all.
Date: Monday, June 23, 2025
Time: 3:30 PM – 5:00 PM
Venue: Conference Hall No 2, India International Centre, Lodhi Road, New Delhi
To attend the event virtually, please register using the link below: https://us02web.zoom.us/meeting/register/ThrWCAxsRjO_74uayjCIVg
Jyotsna Singh, Co-Convenor, Working Group on Access to Medicines and Treatments
This conversation will bring together civil society organisations, academia, and scientific experts to explore how innovation and regulatory reform can help transform access to biosimilars in India, which are used in the treatments of serious or chronic diseases, such as Cancers, Autoimmune disorders, etc.
The meeting will be followed by tea, coffee, and light refreshments. We encourage all participants to stay back and join us.