Dr Rakesh Bhasin, Head R&D (Formulations), Biocon, gave a presentation on ‘The R&D playbook for complex generics’. He offered an in-depth perspective on how pharma companies can approach the development of complex generics, a space that is rapidly gaining importance as the industry looks to expand access to advanced therapies at affordable costs. Dr Bhasin began by underlining the complexities in these products ranging from challenging active ingredients to sophisticated formulations, advanced delivery mechanisms and intricate drug-device combinations. Each of these categories presents unique technical, regulatory and commercial challenges, making the development pathway very different from that of conventional generics.
He outlined the importance of strategic product selection. Here, the focus was on mapping patent expiries, analysing competitive landscapes and assessing value through market dynamics such as price erosion, reimbursement potential and patient volume. He also highlighted the role of market intelligence and early planning. Dr Bhasin spoke about complexity assessment where the scientific challenges of formulation, device integration, and analytical characterisation were explored. He stressed that analytical comparability is often the biggest hurdle, with no single test being sufficient to prove sameness between a reference and a proposed complex generic. He spoke on device-related issues as well, including the need to carefully evaluate pens, auto-injectors, and other platforms for functionality and user interface similarities with reference products.
He also focussed on patent and regulatory pathways. Freedom to Operate (FTO) analyses and patent landscaping were described as essential steps in shaping development strategy, with design-around solutions offering a way to overcome intellectual property barriers. The presentation also covered regulatory expectations in both the US and Europe, particularly the role of design controls, human factor studies and threshold analyses in demonstrating device equivalence.
The session reinforced that developing complex generics requires far more than scientific expertise. It demands a holistic playbook that integrates market intelligence, IP strategy, analytical rigour and regulatory foresight.