Business Plan
Business Development Plan

  • Operation Model "Execution"
    1. R&D: Accelerate development and reduce costs: Tailored development strategy

    UNDBIO is adopting lean models of Insulin, Insulin Analogs and other biosimilars development and rapidly evolving technologies such as data platforms and data analytics to help reduce the residual uncertainties that require new biosimilars to be subjected to human trials. This will accelerate development and reduce costs.

  • Operation Model "Execution"
    2. Regulatory and market access considerations fuel our biosimilar

    UNBIO follows a logical step wise progression to ensure that a global development plan can be leveraged to satisfy regulators in each potential market.

    If a single development plan not appear feasible, we decide whether to undertake a “bridging program” (or separate program) for the concerned market; or, alternatively, improve the product and develop it as a biobetter.

    This creates a clear Regulatory Strategic Road Map, appropriate Clinical strategy and trial design, and commercial, market access considerations

  • Operation Model "Execution"
    3. State of Art Manufacturing Facility

    Our facility shall comply Global GMP standards focusing on Korean, European and USA filings.

    UNDBIO Plans to construct the facilities in various phases

    Phase-1: Drug Substance and Drug Product facility for Insulin, Insulin Analogs and other Biosimilars

    Phase-2: Dedicated facility for SVP, LVP (Contrast media) and Extended release injectable formulations

  • Business Model "Growth Strategy"
    4. Partnership with Drug Device Manufacturing Companies to create synergy and market reach.

    Insulin Pump

    Pen devices

    Smart Blood Glucose Monitoring systems

  • Business Model "Growth Strategy"
    5. Commercialization and Optimization of market Access

    Comprehensive market assessment

    Anticipate competitive scenarios

    Effective market entry strategy

    provide value dossier and value pricing

  • Business Model "Growth Strategy"
    5. Value-chain Partnerships : Commercial model

    We believe that effective commercial approaches strike a balance between different imperatives: making the product more affordable for patients and building tender capabilities to secure volume gains; generating further savings for payers and providers through incentives; and tailoring pricing and channel strategies to individual products and countries to achieve traction at physician level.

    In Korea UNDBIO shall market the product and we shall develop strong local marketing partnerships in the respective geographies.