Biotech Week Boston 2016: Little know facts - Comparator Sourcing from Emerging Market

Little known facts about SourcingComparators from Emerging Markets with Confidence



  1. Facts: Biosimilar Opportunity 2020
  2. Facts: About Biologics
  3. Global Regulatory Pathway
  4. Comparator Examples From Market
  5. Key regulations governing comparator sourcing
  6. Comparator Souring Organisation – Roles and Services.
  1. Facts: Biosimilar Opportunity 2020

    • Biologic drugs with sales over $100 billion set to loose patent by 2020.1
    • Over 3000 companies globally are in the race to develop Biosimilars / Biobetters
    • Over 1300 biosimilars candidates under development
    • The demand for Comparators / RLDs has been estimated at 500,000 units for phase 1 trial through Phase III trials!
  2. Facts: About Biologics
    • If Aspirin’s molecular mass is 180 daltons, that of a Biologic such as mABs is more than 150,000 daltons



    Facts: About Biologics – complex manufacturing process


    Facts : Biologic Manufacturing
    • Every Biologic product displays a certain degree of variability even between different batches of the same product.
    • Even minor changes in production process have to approved by NHAs
    • For example, Genzyme opened a new large plant in an attempt to produce Myozyme (alglucosidase alfa), but the FDA did not consider the product in the new plant to be the same as Myozyme.
    • Instead, Genzyme had to get approval from the FDA through a BLA (Biologic licensing application) for an entirely new biologic, Lumizyme (alglucosidase alfa), which was produced at the new plant. This resulted in a better biologic with new exclusivity.
  3. Facts: Inherent Variability


  4. Global Regulatory Pathway
    How does a Biologic travel from SRA to Emerging Market



    Pathway to Emerging Markets: Product registration Module 1 – CPP and FSC


    What does a CPP look like ?


    Regulatory – Registration
  5. Comparator Examples From Market
    Sourced from USA


    Authorised in USA


    Sourced from France


    Authorised in France




    Taking a product from SRA to Emerging Market


    Is this possible without CPP, eCTD, Registration pathway ?
  6. Key regulations governing comparator sourcing
    Regulatory Senario – USA
    • Important act governing Biologic and Biosimilar Trade:
    • Guidelines on Similar Biological Medicinal product:
    • Section 3.2: Choice of reference product:
    • Restriction: “The reference medicinal product must be a medicinal product authorised in the EEA, on the basis of a complete dossier in accordance with the provisions of Article 8 of Directive 2001/83/EC, as amended”
    • “However, with the aim of facilitating the global development of biosimilars and to avoid unnecessary repetition of clinical trials, it may be possible for an Applicant to compare the biosimilar in certain clinical studies and in in vivo non-clinical studies (where needed) with a non-EEA authorised
  7. Comparator Souring Organisation
    CSO – Comparator Sourcing Organisation
    • Why CSO ?
    • Sourcing of Reference drugs / Comparators has become an “Achilles Heel” of this industry.
    • Ask for 1000 pack – Sorry we offer only 50.
    • Ask for 3 batches – Sorry we have only 1 batch.
    • Ask for CoA – Sorry not provided.
    • Because Sponsors and CROs should be able to focus on trials.
    • CSO such as GNH India a specialised wholesaler of Drugs who understand the complex global regulatory frame work and can help Sponsors and CROs cut cost
    • We navigate the treacherous path of comparator sourcing for you, so you could FOCUS on Development.
    • A 1000 packs – Done
    • 3 Batches – Done
    • CoA, CoC, Pedigree dossier, Temperature record, Recall Agreement –DONE
    • Ship to Timbuktu – Done
    • Cost effective sourcing from Emerging markets can bring this down to 5 – 10%


Other Resources

Biotech Week Boston 2016: Little know facts - Comparator Sourcing from Emerging Market

view & download

Biotech Week Boston 2016: Little know facts - Comparator Sourcing from Emerging Market

Comparators The “Check Nut” of Clinical Trials

view & download

Comparators  The “Check Nut” of Clinical Trials

Our Services

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator Sourcing services from India and RoW markets. Our Service included...
Read More
Name Patient Supply

Name Patient Supply

With rapidly changing lifestyle and ever increasing stress levels, disease patterns have seen a shift towards rarer and more un...
Read More
Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic, proteins etc. temperature maintenance has become as important as the...
Read More
Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE. GNH India brings over 10 years of experience in clinical...
Read More
Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active involvement in Manufacturing and interaction with various laboratories and manufacturers...
Read More
Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following quality levels: US FDA / UK MHRA approved facilities WHO GMP...
Read More


PRICING POLICY Terms of sales are typically prepaid, unless otherwise noted in quotation. The preferred method of payment is wire...
Read More

Copyright © 2021 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.