Over 60 civil society organisations from across the world have written to the Director General of World Health Organisation (WHO) demanding revision of the global health body's 'Guidelines for Evaluation of Similar Biotherapeutic Product (SBPs),' which were adopted in 2009.
Biotherapeutic medicines, also known as biologics, are produced through biological processes and differ from the older generation small-molecule medicines that are derived through chemical synthesis.
"Unfortunately, both accessibility and affordability of this new class of medicines in developing countries is abysmally poor, owing largely to their high prices,’’ noted the group.
Civil Society groups claim that even though a Resolution of the World Health Assembly in 2014 mandates the Director General to convene the WHO expert committee on biological standardization to update the 2009 guidelines, “till date, the secretariat has neither updated the SBP guidelines nor has the WHO given any scientific reasons for the decision,” the group added.
The groups including the Cancer Patients Aid Association (India), Section 27 (South Africa), Third World Network (Malaysia), and Treatment Action Group (USA) have demanded that WHO, in its capacity as the directing and coordinating authority on international health, promptly make public the scientific reasons for insisting on comparative clinical trials for the approval of SBP and urgently take measures to update the SBP Guidelines.
They also sought public consultations to review the scientific evidence with respect to the need for comparative clinical trials, among other things.