1. Era Of Bio Therapuetics
  2. Reverse Planning
  3. Significance Of Source Markets
  4. Effects On Registration, Costs And Time To Market
  5. Key points in sourcing Bio-similar
  6. Comparator Souring Organisation – Roles and Services.
  • Conventional Medication has been used and abused by Humanity for over a century now
  • Human body has started becoming immune to conventional medication
  • Antibiotic resistance is at it’s all time high
  • The next frontier in medicines is Bio-Therapeutics Targeting of Cells at DNA and Gene level
  • What is Reverse planning ?
  • Conventional RnD approach do not work for Bio-similars development
  • Bio-similars are expensive to develop, clinical studies are more complex and Stability even more so.
  • Top down approach of planning the full RnD process, Trials, Studies and then looking for Comparators has led to looses of Millions of Dollors in:
    • Excess stock
    • Expired Stock
    • Wrong Packs
  • Reverse Planning:
    • Start by identifying your Destination Markets
    • For Example a Bio-similar to be registered in EU needs a EU sourced comparator from Innovator with EU number of the pack.
    • While a Bio-similar for registration in RoW markets will accept comparator from any markets as long as it’s from the innovator.
    • This reverse planning can SAVE millions of Dollars in sourcing by selecting the right source markets.
3. Significance of Source Markets
  • Source Markets should be chosen based on your Destination markets
  • For Example if you plan to Target RoW Markets, there’s no point in souring products from US market
  • US products with NDC numbers are at least 3 time more expensive as compared to same brand in International packs
  • US stocks are difficult to get, highly controlled, traced and the sheer cost makes the development process un-viable.
  • In contrast to this : An International pack from Europe / Eastern Europe is available at 1/3rd the cost, in Large quantities and with Pedigree Documents.
Market Intelligence


4. Effects on Registration
  • Ultimate goal of any development is to SELL the product
  • Sell – Fast and First to Market
  • Sell – At Most competitive price
  • Example : India is a Right Hand Drive Country – Is there any point launching a Left Hand Drive Car here ?
  • Similarly if your destination is RoW – there’s no point in Sourcing of US / EU stock for RnD
  • Lack of reverse planning : Only increase development cost hence the END product COST
  • Lack of product availability from US / EU markets – delays development
  • And off course you are not FAST or First to market
5.Key points in Sourcing Bio-Similars
  • Identify your Destination Markets First
  • Check availability, Pack descriptions, SPC etc… of your comparator in planning stage
  • Call for Pack photos, Pack Scans in planning stage
  • Estimate the Quantity, Frequency etc…. in advance
  • Understand availability issues for Comparators right in the beginning.
  • Tie up your source even before you start development process
6. CSO – Comparator Sourcing Organisation
  • While Development and RnD is the a focus of Manufacturers or CROs
  • Sourcing of Innovators / Comparators can be big challenge
  • An ideal CSO should be :
    • WHO GDP Certified Site
    • With validated Storage and Shipping systems
    • With Global Reach
    • Ability to source and transport products world wide
    • Knowledgable about Global Market place
    • In depth Experience in Sourcing, Imports and Exports
GNH India – 1st CSO in India
  • A WHO GDP certified by SGS India
  • DFGT recognised Export house
  • Over 12 years of Industry Experience
  • Qualified QP on site in Warehouse
  • Fully licensed by State FDA and DGFT to carry imports and Exports of Drugs and related products
  • Over 135,000 products
GNH India – 1st CSO in India
  • Shipping and importing Globally to over 180 countries
  • Validated Storage and Shipping systems
  • Full Traceability and Pedigree for every supply
  • In Depth Market knowledge and Market intelligence
  • Complete Regulatory and compliance support up-till Market launch
Market Intelligence – 1 product – 2 packs ??



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