International Nonproprietary Names - who.int · peginterferón beta-1a...

Dr R. Balocco Mattavelli, INN/TSN/RHT

WHO Technical Briefing Seminar on Essential Medicines and Health Products

Geneva, 23-27 November 2015

International Nonproprietary Names




What's in a name?

Safety

Quality

Information

Regulation Rational use use

Procurement

Efficacy




Verba volant scripta manent

"By assigning a single international name to

drugs, WHO helps ensure that a

prescription filled abroad is what doctor

ordered back home."

Dr Margaret Chan, Director General




The WHO International Nonproprietary

Name (INN) Programme

To provide one single name worldwide for active

pharmaceutical substances

Initiated in 1950 by resolution WHA3.11

Operational since 1953

Based on WHO Constitution




INN Programme

Mandated by the Member States in 1953

One of the oldest WHO programmes

To devise a single name for a substance

INNs are recognized in almost all Member States

INNs can be used freely and cannot be registered as

trade names

Not concerned with formulations




Interested parties outside WHO

USAN Program

Pharmacopoeias

(BP, FP, USP, JP….)

European Commission,

WCO, WIPO, …

Research based

industry

National trade-mark

authorities

DRAs

(EMEA, US-FDA….)

INN Programme




Various trade names ®

for one substance, ex. paracetamol




Various generic names





One International Nonproprietary Name





INNs…

Unique name

Distinctive in sound and spelling

Not liable to confusion with other names in

common use

Formally placed by WHO in the public domain

Can be used without any restriction to identify

pharmaceutical substances




The INN System

WHO Secretariat

INN Expert Group

INN Advisory Group on Biological

Publications




The Business Process Model

Broad consultation

Lot of

correspondence

2 INN

meetings/year

"Ad hoc" meetings

……




Reaching the world

INNs Lists are published in WHO Drug Information

All INNs are published in a Cumulative List

On-line INN information: Mednet - INN Extranet

Global Data Hub

http://mednet.who.int/







INN List in practice

peginterferonum beta-1a # (108)

peginterferon beta-1a N2.1-{(2RS)-2-methyl-3-[ω-methoxypoly(oxyethylene)]propyl}human interferon beta

(fibroblast interferon, IFN-beta) glycosylated expressed in mammalian cells

immunomodulator

péginterféron bêta-1a N2.1-{(2RS)-2-méthyl-3-[ω-méthoxypoly(oxyéthylène)]propyl}interféron bêta humain

(interféron fibroblastoïde, IFN-bêta) glycosylé produit par les cellules de mammifères

immunomodulateur

peginterferón beta-1a N2.1-{(2RS)-2-metil-3-[ω-metoxipoli(oxietileno)]propil}interferón beta humano (interferón

fibroblastoide, IFN-beta) glicosilado producido por las células de mamífero

inmunomodulador

C913H1417N246O256PS7 [C2H4O]n 1211327-92-2

H3CO

O NH

CO2H

H

S

CH3

nH CH3

*

and epimer at C*et l'épimère en C*y el epímero al C*

H2N CO2H

H

O P

O

OHOH

Sequence / Séquence / SecuenciaMSYNLLGFLQRSSNFQCQKLLWQLNGRLEYCLKDRMNFDIPEEIKQLQQF50

QKEDAALTIYEMLQNIFAIFRQDSSSTGWNETIVENLLANVYHQINHLKT100

VLEEKLEKEDFTRGKLMSSLHLKRYYGRILHYLKAKEYSHCAWTIVRVEI150

LRNFYFINRLTGYLRN 166

Disulfide bridge location / Position du pont disulfure / Posicion del puente disulfuro31-141

Modified residues / Résidus modifiés / Restos modificados

M1

N-pegMet

S119

O-phosphonoSer

Glycosylation site (N) / Site de glycosylation (N) / Posicion de glicosilación (N)Asn-80




MedNet

communities.net/inn/-https://mednet

https://mednet-communities.net/inn/






INN for a global data hub

Software Company Pharmaceutical Industry

BPh

IMGT

SIB-

University of

Geneva

DRAs

ANSM

WIPO FDA

VIDAL

USP

National Authorities and

various organizations




Use of stems

To indicate chemical and /or pharmacological group relationship

Published for 'established series of related compounds'

INN and stems have protection within trade mark arena

WHO publication "The use of stems in the selection of INN "

Stem book 2013

pre-stems list

Names of "pharmacologically/chemically -related"

substances have a common stem

http://www.who.int/medicines/services/inn/stembook/en/index.html




How long…?

59 names

30% biologicals

12.5 months as an

average

Nearly 95% pub.

after 1 or 2 rounds

of discussion

0

5

10

15

20

25

30

35

40

45

11 m. 12 m. 13 m. 14 m. 15 m. 16 m. 17 m. 18 m. 19 m. 20 m. 21 m. 22 m. 23 m.

Time for publication of a p.INN in List 110




Biologicals are more complex

Interferon beta

MW 19'000D

Aspirin

MW 180D




INN a global name?

epoetin alfa (2x)

epoetin zeta epoetin kappa

(generic recombination)

epoetin alfa biosimilar 1

epoetin lambda




……

This is an issue that does need to be

addressed globally, and soon

The WHO INN Programme has a clear

mandate

The need for a harmonized (global) system

is crucial




History of the Biological Qualifier (BQ)

Some NRA’s requested a global means of identification of

biosimilars

The BQ Proposal developed in consultation with experts

and NRAs and published in Jul 2014

Extensive feedback from all sectors guiding modification

of the Proposal

Feedback to and from NRAs (Mar 2015) & stakeholders

(Jun 2015)




Response from whom?

Academic

Government

Manufact'rs

Industry

Clinical org

Comms org

Funding org

Patient org

Pharm'st org

Personal




Support?

1 - strongly disagree

2 - disagree

3 - partially agree

4 - agree

5 - strongly agree




Whose support?

0

5

10

15

20

25

Negative (1-2)

Neutral (3)

Positive (4-5)




Government support?

0

1

2

3

4

5

6

7

8

9

Asia Canada EMA Europe LatinAmerica

USA

Negative

Neutral

Positive




Summary of current Proposal

BQ Applicants supply:

Name and address of BQ Applicant

INN & form of BQ in all relevant jurisdictions

Trade name(s) of product(s) in all relevant jurisdictions.

Name(s) & address(es) of Marketing Authorisation Holder(s).

Name(s) and address(es) of relevant manufacturing site(s)

Regulatory information: NRA, route & date of marketing

authorisation in each jurisdiction.

Information is stored in a secure WHO database, edited

only by WHO staff, publically available data accessible to

all, manufacturer data accessible only by NRAs.




Format and future

The Proposal had become cumbersome

through the incorporation of feedback and

lengthy explanations of decisions

Separated into concise Proposal and a lengthy

Frequently Asked Questions (FAQ) document

Presented to INN Experts on Fri 17 Oct 2015

and ongoing consultation with NRAs and other

stakeholders.




Conclusion

Majority of stakeholders support BQ, but there

is some opposition.

BQ Proposal modified in response to objections

& suggestions receiving further positive and

negative feedback.

INN will continue to develop &, at the

appropriate time, enhance the concept.




http://blog.gembaacademy.com/wp-content/uploads/2009/04/simplicity.jpg




INN is simple

"Simplicity is the ultimate sophistication"

Leonardo Da Vinci




Thank you

Grazie! Danke! Merci! Obrigado ! Gracias 谢谢！ありがう！ARIGATOU！ Dziękuję! Dank je /

u! Mulţumesc! Teşekkür ederim! Tack!Tack så mycket! Kiitos! תודה לך! Takk! ďakujem,

ďakujem vám ; Hvala! ًشكرا! shokran Ευχαριστώ! 감사합니다 Děkuji! Tak skal du

have! Dankon! Hvala, Hvala lepa, Najlepša hvala Gràcies! Faleminderit Hvala! Ačiū, De’koju,

Labai ačiū ขอบคณุ ; ขอบคณุมาก(khàwp khun) ; (khàwp khun mâak) shukrīya ( )شكريهً) بہت bahut)

Cảm ơn cô ; Cảm ơn cô nhiều; Благодаря!Благодаря! Obrigado!” Gracias Þakka þér! baie

dankie ; Takk fyri! Sipas dekem متشکرم! Благодарам! Hvala Vam! V

Təşəkkür Paldies!Pateicos! / Tencinu! Terima kasih Дуже дякую ;Дякую ; Спасибі! Баярлалаа ; Гялайлаа ; Танд их баярлалаа Terima kasih ধন্যবাদ

(dhonyobād( Salamat! Trugarez ! Mersi !Trugarez Danke!

International Nonproprietary Names - who.int · peginterferón beta-1a...

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