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Civil society groups seek revision of WHO guidelines on Similar Biotherapeutic Products evaluation

Press Trust of India  |  New Delhi 

Over 60 organisations from across the world have written to the of WHO demanding revision of the global health body's 'Guidelines on Evaluation of Similar (SBPs)' which were adopted in 2009.

The regulatory framework for approval of SPBs, put in place by many countries, including India, is in accordance with the WHO guidelines, which the groups claim are "unnecessarily cumbersome".

They allege that the "failure" of the WHO secretariat to update the guidelines in line with current scientific evidence and technological advances, "compromises access to affordable biotherapeutic products" and has "grave consequences for the realization of the right to health and the right to enjoy scientific progress."

Biotherapeutic medicines, also known as biologics, are produced through biological processes and differ from the older generation small-molecule medicines that are derived through

They have advantages over small molecule medicines as they can be designed to hit specific 'targets' in the body and currently dominate treatments for and

Biotherapeutics such as Humira (adalimumab), Keytruda (pembrolizumab), Enbrel (etanercept), Herceptin (trastuzumab) and Avastin (bevacizumab) and Rituxan (rituximab) are among the top selling medicines globally in 2018 in terms of revenue.

Just as generics are non-innovator versions of small molecule medicines, or "biosimilars" are follow-on versions of

"Unfortunately, both accessibility and affordability of this new class of medicines in developing countries is abysmally poor, owing largely due to their high prices.

"Unlike small molecules, where generic uptake is high, the road to uptake of similar is paved with many obstacles, including but not limited to technology, intellectual property and regulatory requirements," said Chetali Rao, an working on law and policy related to biotherapeutics.

groups claim that even though a Resolution of the in 2014 mandates the to convene the 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.

In particular, the groups have raised concerns that the "current SBP guidelines insists on head to head comparison of with the with the goal of establishing similarity in quality, safety, and efficacy".

Citing a memorandum signed by eight scientists calling for revision of the SBP guidelines, they claim that "this insistence of comparative clinical trials makes development of expensive and time consuming.

In addition, there is increasing robust scientific evidence that calls into question the need for comparative clinical trials for the approval of

The groups including (India), (South Africa), (Malaysia), (Colombia) and (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, urgently take measures to update the SBP Guidelines.

They also sought public consultations be held to review the scientific evidence with respect to the need for comparative clinical trials, among other things.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Fri, May 17 2019. 20:06 IST