[Ip-health] CSO letter to WHO Demanding Revision of Bio-similar Guideline to Facilitate Access

K.M. Gopakumar kumargopakm at gmail.com
Fri Oct 18 07:01:30 PDT 2019

18 October 2019

Prof. Klaus Cichutek


Expert Committee on Biologic Standardization

World Health Organization

CC:     Dr. Tedros Adhanom Ghebreyesus, Director-General, World Health

Dr. Maria Angela Simao, WHO Assistant Director-General

Dr Ivana Knezevic, Group Lead Norms and Standards/Biologicals, World Health

*Re: Facilitating Access to New Biologic Medicines- call to update the WHO
Guidelines on Similar Biotherapeutic products*

Dear Prof. Cichutek,

We, the undersigned Civil Society Organizations are writing to request to
the ECBS the update of the 2009 Guidelines on Evaluation of Similar
Biotherapeutic Products at its upcoming meeting as mandated under the WHO
resolution WHA67.21. This is a critical step to expedite access to the
biologic medicines included in the WHO Model List of Essential Medicines

As you know, current evidence suggests that biotherapeutics therapies
(BTPs) play an important role in advancing therapeutic outcomes for several
autoimmune and degenerative diseases and in cancer treatment. However, BTPs
are extremely expensive and consequently not accessible to patients,
especially in Low and Middle-Income Countries (LMICs). For example, the
cost of one vial of adalimumab (for the originator product Humira from
AbbVie) would cost about $1000 - almost equivalent to the average annual
wage in a low-income country. The high prices are a reflection of protected
monopolies in the biotech sector. Unlike in the case of generic equivalents
of small molecule originator drugs, there is no effective competition in
the market for BTPs even in situations where the patents of the originator
molecules have expired. Beyond the technological or intellectual property
barriers, regulatory challenges are the main reason for the lack of
competition and therefore high prices.

The current WHO Guidelines on Evaluation of Similar Biotherapeutic
Products’ *requirement of comparative clinical trials does not take into
account the technological advances for the characterization of
biotherapeutic products, *making the development of non-originator
biotherapeutic products unnecessarily expensive and time-consuming. The
guidelines require a head to head comparison of non-originator
biotherapeutic products with the originator product to establish similarity
in quality, safety, and efficacy.

Additionally, there is robust (and growing) scientific evidence that calls
into question the need for comparative clinical trials for the approval of
non-originator biotherapeutic products (bio competitors). We would like to
draw your attention to the Memo signed by 8 scientists calling for Revision
of the SBP guidelines and for the initiation of the revision of those
guidelines as required as well by the WHA 67.21, which explicitly request
the Director-General to convene ECBS “to update” the SBP guidelines.

While access to essential medicines is an integral part of universal
healthcare, the financial hardships associated with high prices for some
health processes and the inequitable access within and among the Member
States impede progress in achieving Universal Healthcare. Failure of the
ECBS and the WHO Secretariat to update the Guidelines according to the
latest scientific evidence compromises access to affordable essential
biotherapeutic products and therefore it is a limitation to the full
realization of the right to health.

Therefore, we would like to reiterate our request to the WHO's Expert
Committee on Biological Standardization to take the opportunity at the
upcoming meeting *to examine the scientific evidence behind the insistence
of comparative head to head clinical trials under WHO’s Guidelines on
Evaluation of Similar Biotherapeutic Products (SBP Guidelines) and update
those accordingly. We also request you to provide reasons backed by
verifiable evidence  for your decision.  *


1.     Access to Medicines, Ireland

2.     All India Drug Action Network, India

3.     Campaign for Affordable Trastuzumab (India)

4.     Cancer Alliance, South Africa

5.     Cancer Patients Aid Association, Mumbai, India

6.     Cáritas Latin America and the Caribbean (SELACC)

7.     Colombian Bishops Conference

8.     Committee for Citizen Oversight and Cooperation in Health (Colombia)

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

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

11.  Drug Action Forum-Karnataka, India

12.  Fundación GEP, Argentina

13.  Health Gap (Global Access Project), USA

14.  Heart to Heart Foundation, Thailand

15.  IFARMA, Colombia

16.  Initiative for  Health & Equity in Society, India

17.  International Treatment Preparedness Coalition (ITPC) -South Asia

18.  Kenyan Network of Cancer Organizations (KENCO)

19.  LAC-Global Alliance for Access to Medicines

20.  Medicines Information Center of the National University of Colombia

21.  Medicines Observatory of the Colombian Medical Federation

22.  Misión Salud, Colombia

23.  NCD Network, South Africa

24.  No Gracias, Spain

25.  People's Health Movement (PHM)

26.  Public Eye, Switzerland

27.  Red Latinoamericana por el acceso a medicamentos

28.  Salud por Derecho, Spain

29.  Salud y Fármacos, USA

30.  South Africa NCDs Alliance

31.  Stop Aids Now, UK

32.  Third World Network, Malaysia

33.  Universities Allied for Essential Medicines

34.  Yolse, Switzerland

       Concerned  individuals:

1.     Achal Prabhala, Coordinator of the AccessIBSA Project, India

2.     Amulya Nidhi, India

3.     Biswajit Dhar, Professor, Centre for Economic Studies and Planning,
School of Social Sciences, Jawaharlal Nehru University, India

4.     Eldred Tellis, Sankalp Rehabilitation Trust, India

5.     Ganesh Acharya, TB survivor-activist, India

6.     Jan Swasthya Abhiyan, India

7.     Kriti Shukla, Independent Consultant, India

8.     Priyam Lizmary Cherian, Patents and Health Policy Advisor, India

9.     Rupal Panchal, Advocacy for Rights for Rare Disease, India

10.  Swasthya Adhikar Manch, India

11.  T.C. James, Visiting Fellow, Research and Information System for
Developing Countries (RIS), India

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