Roche vs Indian Pharma: The battle for a cheaper cancer drug

Let’s hark back to the Nineties. The HIV-AIDS epidemic was spreading across Africa, leaving thousands dead, in spite of the existence of anti-retroviral drugs (ARVs). 

The cost of the treatment, around $10,000, was prohibitive. Africa, with 7 million patients, was a market none of the top multinational pharmaceutical majors with patented drugs, wanted to address. This stranglehold was broken at the turn of the millennium — by generic players like Indian pharma major CiplaBSE -0.47 %, .. 
, led by its fiery promoter Yusuf Hamied, who decided to supply generic versions of ARVs at $1 a day to the African market. That was 2001. Retaliation from Big Pharma (a term used to describe the world’s top 20 pharmaceutical companies) came through patent litigations in Indian and international trade courts, and branding Indian drug companies as thieves who stole intellectual property to make profits. Seeds of doubt on the quality of India-made drugs were sown among doctors, discouraging them from prescribing generic medications. There is no doubt who won the battle, though. Today India supplies 90% of the ARV drugs across the world. 
And now, it is time for a Nineties re-run. This time the disease is cancer and the drugs are biologics (essentially proteins synthesised or created out of living sources that could be human, bacterial or other) and biosimilars (products that are close to the original biologic product). The battleground this time is India. The companies in the thick of it are Roche, a $51 billion Swiss pharma major, and Biocon, the Bengaluru-based company led by India’s first woman pharma-billionaire, Kiran Mazumdar Shaw. The drug is Trastuzumab, a biologic that impedes the growth of breast cancer cells by blocking the effects of HER-2 protein that sends growth signals to these cells, originally launched in 2002. 
“Biologics and biosimilars areas are fiercely competitive, and the biologic innovators (like Roche) are doing everything to protect their markets; using multipronged strategies like dropping prices, offering patient assistance programmes, extending patents and coming up with bio-betters, newer indications and formulations for their biologics,” says Charu Manaktala, head, Asia Pacific Biosimilars Centre of Excellence at Quintiles, a global clinical research organisation. 
Tussle over Trastuzumab 
The battle over Trastuzumab has been on for a while (see The Trastuzumab Timeline). But last month it took a new, possibly decisive turn, with longterm implications on biosimilars and their sales in India. On April 25, the Competition Commission of India, the antimonopoly watchdog, released its order opening an investigation against Roche for blocking the entry of biosimilar versions of Trastuzumab globally sold under the brand name Herceptin. The director-general of CCI has been asked to investigate and submit his report within a month. 

The CCI’s 36-page order notes that prima facie it appears that Roche used its dominant position to influence regulators and medical professionals against prescribing the biosimilar versions of Trastuzumab manufactured by several Indian drug makers, including Biocon and Mylan. The two companies had complained to the CCI in end-2016 about Roche using anti-competitive measures — from suing the Indian drug regulator for granting approval to manufacture biosimilars to selectively using court’s observations to “intimidate” doctors, chemists and state hospitals.

The Swiss drug maker also wrote letters to government agencies and hospitals to influence tender conditions in its favour, the two companies alleged. 
Devendra Kumar Sikri, chairperson of CCI, wrote in his order: “The Commission is conscious that competitors, in normal business parlance, indulge in tactics to belittle competitors’ products. However, there is a difference between puffery aimed at promoting one’s own product and adopting practices which disparage or malign the image of competitors, thereby causing competitive disadvantages to them.” 

“The line of difference between these two business strategies is very thin, however, when crossed by a dominant enterprise to its own illegal advantage, it warrants intervention by the competition authority,” the order added. 

In an email response to ET Magazine, Roche said that it adheres to all applicable laws and regulations in countries where it operates. 

“All representations to authorities have been based on fair means and in compliance with local laws and regulation.We are fully committed to cooperating with the authorities in India. At Roche, patient safety is our highest priority. As a responsible company, it is necessary for us to communicate to public and private authorities in matters which concern drug and patient safety,” a Roche spokesperson said. 

Biocon, for its part, says its biosimilar has gone through exhaustive development process and is already making a difference to thousands of patients in India. “This key cancer drug has undergone an extensive development process in compliance with the regulatory guidelines for biosimilars. 

When introduced in India in 2014, it became the first biosimilar Trastuzumab to be approved for sale anywhere in the world. The product has demonstrated its safety and efficacy and is being prescribed to breast cancer patients in India by doctors who believe in providing affordable access to their patients”, said Suresh Subramanian, senior vice-president and head, Branded Formulations, India, Biocon

Roche, one of the largest spenders when it comes to new drug developments, can surprise the market with its strategy too. In 2013, for example, when faced with the question of compulsory licencing, it withdrew its patent from India. Earlier this year, Roche reached a settlement with US drug maker Mylan, granting the company a licence for biosimilar Herceptin. 
Mylan holds the rights for developed markets like EU, Japan and Canada; Biocon has rights for the rest of the developed world where the product is yet to be launched. However for India, no one is in a mood to compromise. In fact, the battle is beginning. 

For those in the pharma business, disputes like this are the beginning of several such litigations in biologic drugs which are nearing the patent cliff. In 2015, seven of the top ten selling drugs were biologics, with combined sales worth nearly $50 billion. For Roche, Trastuzumab accounted for $6.7 billion in sales in 2016, around 13% of its total revenues.
Big Pharma companies like Roche also have supporters in India. A day after the April order of CCI came out, a patient group sent out a press note expressing concerns regarding the regulations for biosimilars in India.
The statement referred to a month-old news story on a recall by Indian drug maker Intas of biosimilar drug Rituximab. “Safety for biosimilars has to be monitored judiciously on a drug-by-drug basis and across all disease indications addressed by a particular drug to ensure patient safety,” said Bejon Misra, founder of Patient Safety and Access Initiative of India Foundation. “Owing to the complex nature of biosimilars, pharmacovigilance is an extremely important tool at every level — regulators, drug companies, medical practitioners as well as patients,” he added.
Misra’s organisation has in the past received funding from the Pharmaceutical Research and Manufacturers of America (PhRMA). 

KV Subramaniam, CEO of Reliance Life Sciences, said: “We continue to face roadblocks created by incumbent competitors in institutional tenders. They resort to tactics, like influencing tender specifications, getting patient interest groups to make unsubstantiated complaints to regulators, filing frivolous patent cases and delaying market entry through legal cases.” 

Manaktala of Quintiles, however, feels Indian regulations have enough going to ensure safety of biosimilars. “Though the Indian biosimilars guidelines are not very detailed, if the guidelines were to be interpreted and applied appropriately, the clinical development programmes would be no different from those seen for other markets such as the EU and US,” Manaktala said. 
“This is the same strategy that MNCs used to block the access of HIV medicines in late ’90s, they are repeating the same strategy with biosimilars,” said Leena Menghaney from Doctors without Borders, an aid organisation. Roche says the regulations should promote innovative research and there is a need for more information to be shared publicly. 

“While we are supportive of making innovative biologics accessible to Indian patients, the safety of patients should remain the primary concern when developing, assessing and approving a biosimilar. Additionally, the sample size in the clinical trials of similar biologics needs to be statistically derived based on strong scientific rationale,” a spokesperson of the Basel-headquartered company told ET Magazine. 



Popular posts from this blog

EMA Recommends Extension of Indications for Ramucirumab

Dr. Hootie Warren takes helm of Fred Hutch Global Oncology

Merck announces positive event-free survival data from phase 3 KEYNOTE-522 study of Keytruda to treat triple-negative breast cancer