Busting Myths: Comparator Sourcing from Row Markets

Workshop Busting Myths: Comparator Sourcing from RoW Markets

By

DR. PIYUSH GUPTA (MBBS, MBA)
ASSOCIATE DIRECTOR – BUSINESS DEVELOPMENT
GNH INDIA
MUMBA, INDIA

  1. What’s A Workshop ? And Why This Subject ?
  2. Busting Myths – Common Myths When Sourcing From Row.
  3. Facts From Row Markets
  4. Key regulations governing comparator sourcing
What’s a Workshop ?

What’s A Workshop ?

My Personal Advisor – Mr. Google Says:

A workshop is a single, short (although short may mean anything from 45 minutes to two full days) educational program designed to teach or introduce to participants practical skills, techniques, or ideas which they can then use in their work or their daily lives 

Why this subject now ?
  • We all are interested in Becoming really really Rich and pronto !!!
  • Oops wrong answer…
  • To bring cost effective solution to patients.

Biosimilar-Opportunity

  • Ohh are the products originals or counterfeit ?
  • But even if I agree to buy from RoW, are these equivalent to EU Lines ?
  • Will I get a single batch for 10 packs ?
  • What’s the MA number of the product ?
  • Key regulations governing comparator sourcing
  • Drugs from RoW are counterfeit !!
Ohh are these products originals or counterfeit ?
  • RoW is a Large and Lucrative market for drug marketeers.
  • Indian market is estimated as US $ 20 billion !
  • Component of Branded lines imported into India is approx. 30% i.e. US $
    6 Billion !
  • Every product coming into the country gets registered with local FDA to
    obtain marketing permission.
  • Government of India has implemented Track and trace in collaboration
    with GS1 since 2016: http://dava.gov.in to monitor stocks coming in and
    going out of the country.
Counterfeit ?

Counterfeit

Registration process : eCDT Dossiers

CTD-Triangle

Lets Focus on Module 1

Module-1-CPP

Module 1

Equivalent ?

Equivalent
certificate-of-medicinal-product

Drug Distribution Map for high value lines

drug-distribution

Common Myths When Sourcing from RoW

    • Will I get a single batch for 10 packs ?
      Parameters Belgium India
      Population 11.35 Million 1.25 Billion
      Relapsing MS 0.82% 1.33%
      Patients 93,070 16,62,500
      Product supply ?? ??
  • What’s the MA number of the product ?
  • What is a MA number:Process of reviewing and assessing the dossier to support a medicinal product in view of its
    marketing (also called licensing, registration, approval, etc.), finalised by granting of a
    document also called marketing authorisation (MA) (equivalent: product license)In India Terms MA number is not practised, we have product license system which is linked
    to factory site.For Drugs manufactured in India – ML (Manufacturing license) number is printed on the packFor Drugs imported into India – Import license number is printed on the pack.

    Import license #
  • Key regulations governing comparator sourcing
Regulatory Senario – USA
  • Important act governing Biologic and Biosimilar Development:
  • Biologic price competition and innovation act. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/ ucm216146.pdf
  • Over 110 reference made in this act to “Reference” product (Comparator).
  • Important restriction: (5) General Rules (A) – One reference product per application.
  • No mention of Origin or license status of Reference product!
Regulatory Senario – EU
  • Important Acts governing Biologic and Biosimilar Trade:
  • Guidelines on Similar Biological Medicinal product: http://www.ema.europa.eu/ docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf
  • 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 biosimilar 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 vivo nonclinical studies (where needed) with a “non-EEA authorised”.
White paper

thank-you
global-leader-local-partner

Question time!
  • How Many Of You’ll Are Developing Two Versions Of The Drugs ?
  • One For North America, Europe And Another For Row Markets ?

 

 

 

 

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