The panel discussion titled ‘Biologics and Biosimilars: The Next Leap in Patient-Centric Drug Development’ at the FDD Conclave 2025 brought together leading minds in pharma R&D to examine how the next wave of innovation can better serve patients.
The session addressed a crucial question: how can the future of biologics and biosimilars be shaped to prioritise accessibility, efficacy, and ease of use? Moderated by Dr Ashok Omray, Pharma Consultant, the panel featured Dr Shubhadeep D Sinha, Sr VP and Head of Clinical Development & Medical Affairs at Hetero Labs; Dr Kamal Kumar Upadhyay, VP and Head of R&D Pharma SGI at Biological E; Dr Vasanthakumar Ramu, VP and Head of R&D – Peptides & Complex APIs at Alembic Pharmaceuticals; and Dr Murali Jayaraman, Head of Formulation and Drug Product Development at Dr Reddy’s Laboratories.
Together, the experts dissected both the opportunities and challenges surrounding biologics and biosimilars in the context of patient-centric development. The discussion opened with a focus on peptide-based therapeutics, which have witnessed growing interest for their potential in targeted treatment.
The panel stressed that such products must meet rigorous regulatory requirements to ensure consistent safety, efficacy, and quality—an expectation that is non-negotiable in today’s pharma landscape. However, meeting these standards is not without challenges. One of the most significant scientific hurdles highlighted was impurity profiling in peptides, a process that demands highly specialised analytical approaches.
As the complexity of peptide structures increases, so too does the need for innovative and precise methods to detect and control impurities. Shifting focus to biosimilars, the panel emphasised that the goal of development must go beyond replication of originator products. Instead, biosimilars should strive to enhance patient outcomes by being not just clinically effective, but also user-friendly.
This evolution is critical in a healthcare environment that increasingly values the holistic patient experience. To this end, the ability to self-administer medication at home was cited as a transformative feature in future biologics and biosimilars. Such formats not only reduce the burden on healthcare infrastructure but also empower patients, improve adherence, and support better long-term outcomes. Affordability and access emerged as central concerns as the session drew to a close.
The panellists were aligned in their view that widespread adoption of biosimilars hinges on making them economically viable for a broader population. As healthcare systems globally face rising costs and uneven access to therapies, biosimilars hold immense promise in closing these gaps—provided the industry remains committed to their widespread availability.
The panel’s insights reflected a common thread: that the future of drug development must be shaped not just in labs or boardrooms, but with the patient at the centre. With the right balance of scientific rigour, and innovation, biologics and biosimilars are poised to lead the next leap in patient-focused care.