India Market Entry Strategy 3 Elizaria (Generium) Immediate Revenue via Named Patient Import + Full Biosimilar Registration

STRATEGIC CONTEXT Product & Regulatory Context Product Profile Elizaria is a biosimilar biologic manufactured by Generium (Russia), currently unregistered in India. The Central Drugs Standard Control Organisation (CDSCO) serves as the regulatory authority governing market access. India permits Named Patient Import under Form 12B for life-saving and unmet-need therapies prior to full marketing authorisation, creating a unique opportunity for immediate market entry whilst pursuing comprehensive registration.

CORE STRATEGY Dual-Track Market Entry Strategy We recommend executing two parallel pathways to maximise both immediate revenue opportunity and long-term market positioning. This approach enables near-term cash flow whilst building sustainable regulatory infrastructure. Track 1: Immediate Access Named Patient Import (Form 12B) 4 physician-driven, patient- specific imports with no local clinical trials required. Commercially viable for oncology and biologics with rapid approval. Track 2: Long-Term Presence Full Biosimilar Registration with CDSCO 4 comprehensive marketing authorisation and import licence enabling broad commercial distribution across India's healthcare system. Both tracks can run in parallel, with Form 12B generating revenue whilst registration proceeds through CDSCO review.

Track 1

Named Patient Import (Form 12B) Regulatory Basis Governed by Rule 36 of the Drugs & Cosmetics Rules, enabling import for individual patient use with case-by-case approval from CDSCO or State FDA authorities. Approval Timeline: Typically 234 weeks from application submission Key Regulatory Features No product registration required with CDSCO No CDSCO GMP facility inspection necessary No Indian clinical trial data mandated Physician prescription and patient medical justification sufficient Suitable for compassionate use and early access programmes Medical Justification Patient clinical rationale and records Regulatory Approval CDSCO or State FDA case-by-case review Physician Prescription Treating doctor issues prescription Import & Delivery Import clearance, ship to patient Form 12B Application Submit application under Rule 36 This streamlined pathway enables immediate physician engagement and revenue generation whilst demonstrating product demand to support future commercial planning.

COMMERCIAL IMPACT Track 1

Revenue & Market Intelligence Immediate Revenue Visibility Generate cash flow from day one through physician-driven demand, eliminating the 24336 month wait for full registration approval. Key Opinion Leader Engagement Build relationships with leading oncologists and specialists who will become advocates for broader adoption post-registration. Demand Validation Collect real-world usage data to support pricing assumptions, volume forecasts, and distribution strategy for full market launch. Compassionate Access Address urgent patient needs whilst demonstrating corporate commitment to Indian healthcare, strengthening stakeholder relationships.

Track 2

Full Biosimilar Registration Regulatory Framework Full market authorisation requires compliance with the New Drugs and Clinical Trials Rules (NDCTR) 2019 and CDSCO Guidelines on Similar Biologics (2016), submitted via the SUGAM portal. Expected Timeline: 24336 months from initial submission to approval Core Requirements Comparative quality and analytical characterisation data Indian pharmacokinetic/pharmacodynamic bridging study (mandatory) Comparative clinical efficacy study (highly likely) CDSCO Good Manufacturing Practice facility inspection Pharmacovigilance plan and post-marketing surveillance commitments

TECHNICAL REQUIREMENTS Clinical & GMP Compliance Summary CDSCO maintains rigorous standards for biosimilar approval, requiring India-specific clinical evidence alongside manufacturing quality verification. Requirement Area CDSCO Expectation Indian Clinical Study PK/PD bridging study mandatory; comparative efficacy study highly likely required CDSCO GMP Inspection Manufacturing facility inspecti on highly probable; site readiness essential PIC/S / EU / WHO GMP Accepted as supportive document ation only; does not replace CDSCO inspection Russian GMP Certification Insufficient as standalone evidence; India-specific compliance verification required Generium's Russian manufacturing facility will require CDSCO inspection and likely facility upgrades to meet Indian regulatory expectations.

Risk Separation & Compliance Integrity Regulatory Independence Form 12B imports operate under a completely separate regulatory framework from full biosimilar registration. Named patient access does not prejudge or influence the CDSCO registration outcome. No data collected through Form 12B imports is treated as pivotal clinical evidence for registration purposes. CDSCO explicitly permits parallel early access programmes alongside formal regulatory evaluation. This separation protects the integrity of both pathways whilst enabling commercial activity during the registration timeline.

STRATEGIC ADVANTAGES Why the Dual-Track Approach Wins Early Physician Familiarity Build prescriber confidence and product experience before full launch, creating demand pull when registration completes. Real-World Safety Visibility Accumulate post-market safety data demonstrating product performance in Indian patient population. Revenue During Regulatory Wait Generate immediate cash flow and validate commercial model whilst registration proceeds through CDSCO. Stakeholder Confidence Demonstrate market commitment to distributors, hospitals, and payers, facilitating partnerships for full launch. Stronger CDSCO Engagement Evidence of physician demand and patient benefit strengthens regulatory discussions and demonstrates market need.

EXECUTIVE DECISION Recommendation

Execute Dual-Track Strategy 1 Immediate Named Patient Import (Form 12B) Launch within 234 weeks Begin revenue generation 2 0318 Months Revenue Ramp via Form 12B Build physician network Validate commercial assumptions 3 24336 Months Full CDSCO Registration Complete clinical trials Obtain marketing authorisation CEO Decision Frame India entry for Elizaria should not wait for registration. Form 12B provides immediate, lawful revenue access, whilst full registration builds long-term scale and sustainable market presence. Dual-Track Benefits Short-term monetisation via Named Patient Import Long-term value via CDSCO biosimilar approval Risk mitigation through parallel pathway execution Enhanced stakeholder confidence and market positioning