K.M. Gopakumar kumargopakm at gmail.com
Fri May 17 02:23:49 PDT 2019


16th May 2019

Dr. Tedros Adhanom Ghebreyesus

Director General

World Health Organisation

*Re: Revision of the WHO Guideline on the Evaluation of Similar
Biotherapeutic Products (SBPs) *

Dear Dr. Tedros,

We, the undersigned Civil Society Organisations (CSOs) are writing to
request the updating of *WHO Guideline on the Evaluation of Similar
Biotherapeutic Products (SBPs)* (SBP Guideline) as mandated by the World
Health Assembly (WHA) resolution.

In 2014 WHA adopted resolution titled "Access to biotherapeutic products
including similar biotherapeutic products and ensuring their quality,
safety and efficacy" (WHA 67.21). It requests the Director-General: "*to
convene the WHO Expert Committee on Biological Standardization to
update the 2009 guidelines, taking into account the technological advances
for the characterization of biotherapeutic products and considering
national regulatory needs and capacities and to report on the update to the
Executive Board*”. However, till date, the Secretariat has not updated the
SBP Guideline.

Instead of updating the SBP Guideline the Expert Committee on Biologic
Standardisation (ECBS) decided to publish questions and answers (Q&A) on
SBPs to complement the SBP Guidelines. The Q&A states: *"In April 2015, an
informal consultation was organized during which participants from NRAs of
both developing and developed countries, as well as from industry,
recognized and agreed that the evaluation principles described in the
Guidelines were still valid, valuable and applicable in facilitating the
harmonization of SBP regulatory requirements globally. It was therefore
concluded that there was no need to revise the main body of the existing
Guidelines.” *We would like to point out that this statement goes against
WHA67.21, which explicitly requests the Director General to convene ECBS *“to
update”* the SBP Guideline. It did not require the ECBS to assess whether
to update it. In addition, neither the ECBS nor the WHO has given any
scientific reasons for the decision to not update the SBP Guideline.

The current SBP Guidelines insists on head to head comparison of
non-originator biotherapeutic product with the originator product with the
goal of establishing similarity in quality, safety, and efficacy. This
insistence of comparative clinical trials makes development of
non-originator biotherapeutic products expensive and time consuming. In
addition, increasingly there is robust scientific evidence that calls into
question the need for comparative clinical trials for the approval of
non-originator biotherapeutic products (biosimilar). The Q&A approved by
the ECBS merely restates the content of SBP Guideline in the form of a Q&A
form. It does not take into consideration the currently available
scientific evidence. Apart from insisting on comparative clinical trials,
the Q&A also does not adequately address extrapolation and

We would like to draw your attention to a Memo signed by 8 scientists
calling for Revision of the SBP Guidelines.[1] We request you to initiate
the revision of the SBP Guidelines as required by WHA67.21, based on the
following principles mentioned in the Memo:

   - Demonstration of similarity in quality is sufficient to assure the
   safety and efficacy of most products.
   - Emphasis on quality testing should focus on impurity profiles and
   - Well-designed pharmacokinetic/pharmacodynamic (PK/PD) studies will be
   sufficient if clinical studies are needed.
   - Immunogenicity studies are only needed if SBP does not match the
   critical quality attributes related to manufacturing.
   - Interchangeability and extrapolation to all indications should be the
   default unless there are scientific reasons to deny extrapolation.

Failure of the ECBS and WHO Secretariat to update the SBP Guidelines to
reflect current scientific evidence and technological advancements,
compromises access to affordable biotherapeutic products, as the
unnecessary requirements of the SBP Guidelines hinders the prompt
availability and accessibility of affordable SBPs with grave consequences
for the realization of the right to health and the right to enjoy
scientific progress and its applications (right to science).

*In the light of the above-mentioned concerns, we request WHO as the
directing and coordinating authority on international health work in the
interest of public health:*

·     *To promptly publish in verbatim records of the informal meeting of
national regulatory authorities which decided not to update the Guideline
mandated by WHA 67.21; *

·     *To promptly make public the scientific reasons for insisting on
comparative clinical trials for the approval of SBP;*

·     *To urgently take measures to update the SBP Guidelines in light of
new scientific evidence as mandated by WHA 67.21 with a focus on clinical
trials requirements for marketing approval, default extrapolation as well
as requirements regarding interchangeability to facilitate switching to

·     *To urgently hold public consultations to review the scientific
evidence with respect to the need for comparative clinical trials and the
possibility of default extrapolation and interchangeability issues.*


1.   Affordable Trastuzumab Campaign, India

2.   Alianza LAC - Global por el Acceso a Medicamentos (Global)

3.   Acción Internacional para la Salud – Perú (Health Action International
- Perú)

4.   Act Up-Basel, Switzerland

5.   Access, France

6.   Agora Society Malaysia

7.   All India Drug Action Network, India

8.   Asia Pacific Council of AIDS Service Organizations (Regional)

9.   Asia Pacific Network of People Living with HIV/AIDS (Regional)

10.           Associação Brasileira Interdisciplinar de AIDS (ABIA), Brazil

11.           Asociación por un Acceso Justo al Medicamento, Spain

12.           Canadian HIV/AIDS Legal Network, Canada

13.           Cancer Alliance, South Africa

14.           Cancer Patients Aid Association, India

15.           Caritas Latinoamerica y el Caribe (Regional)

16.           Centro de Pensamiento Medicamentos, Información y Poder,
Universidad Nacional de Colombia

17.           CIMUN, Universidad Nacional del Colombia

18.           Comité de Veeduría y Cooperación en Salud (Committee of
Oversight and Cooperation in Health), Colombia

19.           Conferencia Episcopal de Colombia (Colombian Council of
Bishops), Colombia

20.           Consumer Association Penang, Malaysia

21.           CureSMA Foundation of India

22.           Delhi Network of Positive People (DNP+), India

23.           Federación Médica Colombiana (Colombian Medical Federation),

24.           Fundación IFARMA, Colombia

25.           Foundation for Research in Science Technology and Ecology,

26.           Fundación Grupo Efecto Positivo (GEP), Argentina

27.           Global Humanitarian Progress Corporation, Colombia

28.           Grupo de Trabalho sobre Propiedade Intelectual (GTPI), Brazil

29.           Hemophilia Society Mumbai Chapter, India

30.           Health GAP (Global Access Project)

31.           Health Innovation in Practice (HIP)

32.           Initiative for Health and Equity in Society, India

33.           International Treatment Preparedness Coalition South Asia

34.           International Treatment Preparedness Coalition - Latin
America and The Caribbean (Regional)

35.           Just Treatment, UK

36.           Kenya Legal and Ethical Issues Network, (KELIN), Kenya

37.           Kenyan Network of Cancer Organizations, Kenya

38.           Knowledge Ecology International, USA

39.           Labor Education and Research Network (LEARN), Philippines

40.           Lawyers Collective, India

41.           Misión Salud, Colombia

42.           OBSERVAMED, Colombia

43.           NO GRACIAS, Spain

44.           People’s Alternative Study Center for Research & Education in
Social Development (PASCRES), Philippines

45.           Pan-African Treatment Access Movement (PATAM), Zimbabwe

46.           Peoples’ Health Movement (Global)

47.           Políticas Farmacéuticas, Chile

48.           Positive Malaysian Treatment Access & Advocacy Group
(MTAAG+), Malaysia

49.           PT Foundation, Malaysia

50.           Public Eye, Switzerland

51.           Red Latinoamericana por el Acceso a Medicamentos (RedLAM)

52.           Salud y Farmacos, USA

53.           Salud Por Derecho (right to health foundation), Spain

54.           Salud Visible, Universidad de los Andes, Colombia

55.           SDG Center for Latin America and the Caribbean (Regional)

56.           SECTION 27, South Africa

57.           Sentro (Sentro ng mga Nagkakaisa at Progresibong Manggagawa),

58.           Treatment Action Group, USA

59.           Third World Network, Malaysia

60.           Treatment Action Campaign, South Africa

61.           Vietnam Network of People living with HIV (VNP+), Vietnam

62.           Women's Coalition Against Cancer (WOCACA), Malawi

63.           WomanHealth, Philippines

64.           Yolse, Switzerland

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