Insulins(Halozyme)

By Vishal Kumar Singh Mumbai: India’s biosimilar ecosystem is expanding fast, but navigating the regulatory maze remains a major hurdle—especially for stakeholders trying to bring affordable innovation to market. At the panel discussion titled "Easing Biosimilar Trials: The Role of Regional Cooperation," under the second edition of ETPharma Clinical Research and Excellence Conference (CREC) moderated by Viraj Suvarna, Independent Healthcare Consultant, industry leaders explored how regulatory clarity, cross-border collaboration, and trust-building could unlock biosimilars ’ potential especially for chronic and rare diseases. The panel featured Dr. Khokan Debnath, Senior GM of Clinical Operations, Regulatory Affairs, and Pharmacovigilance Compliance , QA (India & ROW), Wockhardt Ltd and Dr. Dipanjana Datta, Genetic Counselor and State Coordinator for the Organization for Rare Diseases India, whose frontline experiences with rare disease challenges added a critical patient-centric lens. India’s updated biosimilar guidelines propose waivers for animal studies and, in select cases, Phase III clinical trials when robust structural and functional similarity is demonstrated. While this aligns with global trends toward reducing redundancy, panelists emphasized unresolved ambiguities. Aligning Policy with Practice: India’s Regulatory Landscape Opening the session, Dr. Viraj Suvarna invited Dr. Khokan Debnath to share his views on the revised biosimilar guidelines issued by the Central Drugs Standard Control Organization ( CDSCO ). Dr. Debnath noted the inclusion of modern scientific tools, like in vitro and orthogonal similarity studies, which now have the potential to replace in vivo trials. However, he flagged serious concerns about procedural clarity. “Suppose I give my dossier on day one—whether on day 30 they will say that your dossier is complete and you will get a waiver, or whether questions will keep coming—that remains unclear,” he said, pointing out the absence of timelines and predictability that could delay patient access. Beyond timelines, he called for regulatory nuance in differentiating simple and complex biosimilars. Drawing on examples like insulin, he noted that “we cannot really do an immunity study on insulins,” emphasizing the difficulty of applying generic trial protocols across diverse biologics . The call was not just for policy updates—but for better interpretation and implementation by industry and regulators alike. To improve efficiency, Dr. Debnath recommended a “deemed approval” system—where applications proceed automatically if left unanswered within a defined period—and a feedback mechanism with stage-wise guidance from DCGI. He concluded by bringing the focus back to the patient. “We need to come up with a solution which is compatible with patients , something they can use on a regular basis and not lose compliance,” he said. Gaps in the Draft: Clarity, Biomarkers, and Surveillance Dr. Deepanjana Datta added to the discourse by spotlighting two specific gaps in the current framework: insufficient guidance on trial waivers and inadequate provisions for post-approval surveillance. Dr. Datta echoed concerns around the ambiguity in defining residual uncertainty and selecting robust biomarkers—critical elements for determining whether a Phase III trial waiver is justified. She emphasized that while the guidelines reference these criteria, they fall short of offering clear direction on how such studies should be structured or evaluated. Her concern centered on the absence of definitions for core scientific parameters—making it difficult for manufacturers to align their studies with regulatory expectations. Dr. Datta also raised concerns about the lack of clarity in the draft guidelines regarding pharmacovigilance protocols and standards for establishing interchangeability with reference biologics. She pointed out that the framework does not sufficiently address how comparability with the original product should be demonstrated. Yet, she expressed hope that future iterations of the draft would bring more precision, helping shape a robust, transparent biosimilar ecosystem. Scientific Rigor vs Speed: Finding the Balance Dr. Viraj Suvarna acknowledged the intent behind regulatory updates while underscoring the need for scientific rigour. “The first step of that triangle, right at the bottom, is the biggest, which is the structural and functional characterization. If that you do well… then only the next steps come in,” he explained, reiterating the foundation of biosimilar evaluation. While he supported efforts to speed up approvals, he cautioned against bypassing clinical validation. “People want to do away with clinical trials so that you can come faster to market… but we’re dealing with a biologic. Even that biosimilar is a biologic,” he said. He also highlighted sourcing issues: “Are you purchasing that original reference biologic from the innovator, or are you purchasing it from elsewhere? That is also important.” Rare Diseases and Equity: Bridging Access Gaps The conversation then shifted to rare diseases, with Dr. Suvarna asking how biosimilars could make treatments more accessible in high-cost conditions like hemophilia and Pompe disease. Dr. Datta was candid. “The cost, whatever therapies we have, are huge,” she said. “Either the government is bleeding, or the family of the patients are bleeding.” She acknowledged R&D costs but pointed to existing biosimilars for molecules like rituximab that had made a real difference in patient access. Still, she flagged the ongoing reluctance among clinicians. “Are clinicians comfortable prescribing biosimilars? They are not,” she observed. She proposed involving patient advocacy groups to build trust and promote adoption. Interestingly, she saw biosimilars not as competition, but as catalysts for innovation. “If biosimilars come in, then it’s an innovation which will be disruptive… but will also pave more ways for innovation,” she said. Market Challenges: ROI, Logistics, and Awareness Dr. Debnath brought attention to the unique constraints of developing biosimilars for rare diseases. “For a pharma company, also making a biosimilar for rare disease is a challenge… they don't see a market,” he noted. Lack of government support and perceived low ROI often discourages investment in this area. To address this, he stressed global logistics and collaboration. “We have to make the pharma companies aware that there's a market available… biosimilars increase competition,” he said, asserting that competition from biosimilars forces innovators to lower prices—benefitting patients. Toward Regulatory Harmony: Cross-Border Approvals Dr. Suvarna proposed regional harmonization as a possible solution. “Can we have some kind of regulatory harmonization… so it’s much faster to market?” he asked. Dr. Debnath stated that, “I have very good examples where trials of insulins are being used in Malaysia or Philippines,” he said. He emphasized that robust safety systems are increasingly valued over replication of local trials. Trust and Data: Building Acceptance Among Patients and Clinicians Dr. Suvarna raised another crucial issue: adoption. Despite growing availability, only a small fraction of doctors prescribe biosimilars. “What about the inclusion of patient-reported outcomes and experiences?” he asked. Dr. Datta highlighted how advocacy groups could fill this trust gap. “If we have data on patient outcomes or experiences, that is a very positive point,” she said, adding that patient advocacy and support groups are often better positioned to track long-term data and report adverse events—roles clinicians may struggle to fulfill consistently. Dr. Debnath echoed the need to build both “confidence for the doctors and trust for the patients.” He emphasized the importance of post-marketing studies and continuous real-world data collection to demonstrate a sustained commitment to safety, efficacy, and patient well-being. Final Points: Identification, Interchangeability, and Education Dr. Suvarna closed with two technical aspects. he emphasized that every biologic and biosimilar has a four-letter unique suffix, which should be reported along with the brand name, so that it is clear whether an event is associated with a particular biosimilar, or another biosimilar. Second, he discussed interchangeability studies, citing FDA’s “three-switch” requirement. This, he explained, is essential to show that patients can switch between reference and biosimilar products safely. Panelists agreed that India’s biosimilar ecosystem holds immense promise—but realizing it will require regulatory clarity, patient trust, and industry-wide collaboration. With the right structures in place, biosimilars could truly democratize access to complex therapies—across price points, across geographies, and across generations. By Online Bureau ,