BY INVITATION. Competition is the key to making drugs affordable

Over the past decade, generic drug manufacturers from India have ventured into developing and registering biological medicines, creating an opportunity to use competition as a tool to bring down prices on the most expensively priced treatments in the world.

Among them are two monoclonal antibodies (mAbs), now listed in the World Health Organisation’s (WHO) essential drug list to treat cancer. Breast cancer drug trastuzumab is one of them.

In 2014, an Indian pharmaceutical company was the first to receive approval to market a biosimilar of trastuzumab. Almost immediately, the Swiss pharmaceutical originator of the drug stepped in to protect its market and keep out a similar version.

The move whipped up quite a stir. The exorbitant price of trastuzumab marketed as Herceptin by Roche drew a visceral reaction from affected women, cancer groups and treatment activists around the world. In South Africa, Tobeka Daki, a woman diagnosed with breast cancer. died; she had been denied a chance of survival — not for medical reasons but because the drug cost $38,365.

In India, women diagnosed with HER+ breast cancer face a similar fate; families are now selling their assets and eating into their savings and seeking support from the Prime Minister’s National Relief Fund inorder to procure the drug for the 17 cycles that are routinely prescribed. While the biosimilar version, too, is not affordable, it has at least led to competition that has started to lower prices dramatically, bringing some relief to women who are desperately seeking access to the drug.

Roche’s attempt to prevent competition to its exorbitantly priced trastuzumab also elicited a strong response from the Competition Commission of India (CCI). The CCI ordered an investigation into Roche’s attempts to create a negative impression about the “propriety” of the regulatory approvals and the safety and efficacy of biosimilars in the medical fraternity, including doctors, hospitals and tender authorities. Taken together, these appear to be aimed at undermining competition in the market.

Access to biological cancer drugs is already complicated by the complex regulatory process for approval by national regulatory authorities. The term “biosimilars” is a misnomer: most national regulatory authorities insist that competitors not only conduct Phase 1 and 2 trials, but also comparative studies in the final phase, before they receive final regulatory approval. Often, this dual requirement of treating each biological medicine from a non-originator source as a new drug, with the additional requirement of proving biosimilarity, takes so much time and investment that barely a handful of companies compete with giants like Roche.

When biosimilars make it to the market, they face stiff resistance from pharma corporations, who try and prevent competition by using unethical tactics to create doubts about their safety and efficacy in the medical fraternity, including doctors, hospitals and procurers.

But the CCI has stepped in and ordered one of the first investigations into the biological medicines market and strategies that pharmaceutical corporations use to block competition. Its actions highlight the need to protect and promote competition in the area of biological medicines. The progress of the investigation will be followed globally.

In parallel, the WHO has invited manufacturers to submit applications for quality assurance of biosimilar versions of two products on its list: rituximab (used to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia), and trastuzumab (for breast cancer). The decision came after a two-day meeting in Geneva of the WHO, national regulators, pharmaceutical industry groups, patient and civil society groups, payers and policymakers to discuss ways to increase access to biological medicines.

This move is timely, since there is an urgent need to address the deliberate confusion created by pharmaceutical corporations over approvals, prescription and sale of more affordable biosimilars that compete with their biological products in the developing world.

The writer is a lawyer working on public health and access to medicines in India. Views expressed are personal.

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