Civil society groups red-flag access concerns as WHO committee meets on biological products

As an expert committee of the WHO deliberates in Geneva on biological products, international civil society groups and scientists are sounding a note of caution on the evolving guidelines that could affect access to these critical products.

In a joint letter, 34 international civil society organisations and 11 individuals from India have urged the WHO’s Expert Committee on Biological Standardisation to revise and update its “Guidelines for the Evaluation of Similar Biotherapeutic Products” in a manner that is scientific, does not compromise on safety, or push up the cost of the drugs. A decision is expected by the end of this week, an expert familiar with the issue told BusinessLine .

Explaining the core concern, the expert pointed out that the 2009 guidelines required a head-to-head comparison of the originator product with the one that claimed to be a therapeutic equivalent. This increases the cost of trials for the manufacturer of the equivalent product and thereby decreases the number of players in the segment, the expert said.

In fact, some experts at the WHO meet are said to have submitted to the committee that scientific methods are available to prove that the comparative product is just as effective as the original one and these can be done without having to undertake a full-fledged trial.

Cost factor

Biological drugs or biotherapeutics therapies (BTPs) are made from living organisms and are complex to manufacture. While these are critical in treating autoimmune and degenerative diseases and cancer, they are also very expensive. A bio-similar product that claims to be therapeutic equivalent is relatively less expensive.

Revising the rules is critical “to expedite access to the biologic medicines included in the WHO Model List of Essential Medicines,” the civil society representatives said in their letter. “BTPs are extremely expensive and, consequently, not accessible to patients, especially in low and middle-income countries,” the letter pointed out.

“The cost of one vial of adalimumab (for the originator product Humira from AbbVie) would be about $1,000 — 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,” it added.

Beyond technological or IP barriers, regulatory challenges are the main reason for the lack of competition and high prices, the letter further said. “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),” it added.

Failure to update the guidelines according to the latest scientific evidence, it said, will compromise “access to affordable essential biotherapeutic products and therefore it is a limitation to the full realisation of the right to health.”

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