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Selection of comparator. Drs. Jan Welink. Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009. Introduction. Quality of generics:. Introduction.

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Selection of comparator

Drs. Jan Welink

Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009


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Introduction

Quality of generics:


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Introduction

Multi-source (generic) drug products must satisfy the same standards as those applicable to the originator’s product. In addition, reasonable assurance must be provided that they are, as intended, clinically interchangeable with nominally equivalent market products.


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Comparator

Introducing the comparator:

* a pharmaceutical product with which the multi-source product is intended to be interchangeable in clinical practice.

* the selection of the comparator product is usually made at the national level by the drug regulatory authority.


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Comparator

Quality

Clinical

Pre-clinical

Introducing the comparator:

innovator product, approved on full documentation:

- established safety and efficacy



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BE

WHAT IS THE RELATION BETWEEN INNOVATOR AND GENERIC?

Scientifically:

INNOVATOR

GENERIC



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Comparator

Selection by the DRA:

  • choose national granted innovator for which quality, safety and efficacy has been established (nationally authorised innovator)

  • choose WHO comparator product from the comparator list (WHO comparator product)

  • choose innovator product from well-regulated country (ICH et al. innovator)

  • if no innovator can be identified, choice must be justified


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Comparator

Justification if no innovator can be identified:

  • approval in ICH- and associated countries

  • pre-qualified by WHO

  • extensive documented use in clinical trials (reports)

  • long and unproblematic post-market surveillance


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List A and B

WHO provides a list with comparator products

- information DRA/pharmaceutical companies

List A: WHO model list of Essential Drugs

- ‘best’ innovator products on national markets

List B: Products for which no innovator product could be identified

- no equivalence test can be performed

- quality, safety and efficacy based upon local, national, or regional pharmacopoeia

- innovator products with insufficient information

No innovator, but market leader available!

………………………………

………………………………


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Decision tree

Choosing comparator complex

WHO provides criteria decision tree

NO

YES

?

?

YES

NO

NO

?


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Decision tree

Innovator product known?

Consider innovator product as comparator

Consider obtaining innovator: List A

Innovator product available?

Available on local market?

Consider innovator product as comparator

Consider market leader product

Comparator pharmaceutical product of known quality, safety and efficacy

+

+

-

+

-


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Decision tree

Comparator pharmaceutical product of known quality, safety and efficacy

Innovator product known?

Present on List B?

Follow compendial standard approach

Acceptable results?

Quality market leader known?

Consider market leader product as comparator

Consider market leader product

Conduct comparative compendial tests on multisource and market leader products

Consider second market leader product

Consider market leader product as comparator

-

-

+

-

+

+

-


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Bio-creep

Annex 11 also written for a single market

WHO:

cannot be translated in case other countries are at stake

national comparator may be the national market leader

no problem in that market

but others!?


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Bio-creep

Interchangeable

Not interchangeable


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EMEA (Europe)

Differentiate between use for single market or many countries!

EMEA:

For an abridged application claiming essential similarity to a reference product, application to numerous Member States based on bioequivalence with a reference product from one Member State can be made.


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Prequalification project

List of acceptable reference products for the prequalification project for reproductive health

List of acceptable reference products for the prequalification project for reproductive health


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Conclusion

- Let quality rules

- Comparators helps you into quality

- Do not fall in the bio-creep


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End

Thank you for your attention


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