Swiss pharmaceutical company Roche is conducting consistent legal battles against smaller companies to dissuade them from entering the market of breast cancer medication reports The Wire. They claim that this has, in effect, granted Roche a monopoly over the biosimilars market, with an emphasis on the breast cancer medication trastuzumab. As a result, there is no chance of competition in the market driving down prices.
Trastuzumab is a monoclonal antibody, referred to as “targeted therapy” due to its specificity to a binding site located on HER2, a cell-surface protein. Some tumours overexpress this protein and so there will be an abundance of binding sites for the antibody to attach to. The overexpression of HER2 causes cancer cells to grow and replicate at an accelerated pace. In cancer cells the functional effect of the medication is to block these sites and prevent this accelerated growth. This has been shown to increase survival rate (risk reduction of 28 percent) when used during chemotherapy.
“Cutthroat on an international scale”
The biosimilars industry has become cutthroat on an international scale, with lawsuits between companies becoming regular occurrences. This owes itself to the nature of the products, created with the intention of mirroring the original as closely as possible. Lawsuits are currently underway between Roche and Amgen regarding another cancer fighting antibody – Avastin. Roche is also engaged in legal action with fellow Swiss pharmaceutical company Novartis. Russian company Biocad accuses Roche of using illegal tactics to force them out of business such as “deliberately setting the price too low”.
Women’s rights groups, both globally and in particular, India, have been up in arms due to the price of the drug. In a discussion with The Wire, Kalyani Menon-Sen, a women’s rights activist in India has recalled personal accounts of those unable to afford drugs produced by Roche – specifically Trastuzumab.
In the case of Menon-Sen’s friend, who was diagnosed with HER2+ breast cancer, her doctor had not mentioned the potential for using Trastuzumab. As well as a women’s rights activist Menon-Sen is also coordinator for Campaign for Affordable Trastuzumab in India, and so visited the doctor alongside her friend. The doctor simply said that he had not mentioned the medication as it would cost over sixth months’ worth of her friends salary.
Trastuzumab: an essential medicine
Trastuzumab was first approved in India in 2000, initially at a price of Rs 135,200 for a 450mg vial. In 2013, the Ministry of Health insisted on a mandatory license for the medication; Roche at this point reduced the cost to Rs 75,000 per vial. Dependent on the stage of the cancer the dose may be between 2mg and 8mg for the early stages of chemotherapy, applied every 90 minutes. At this rate the vial provides roughly 56 doses, and will last just three and a half days before another vial must be purchased.
In 2015 India added Trastuzumab to the national list of essential medicines, capping the price at Rs 55,812 in the process. Though this is continuing in the right direction, in a country where the average monthly salary is only Rs 18,117 this still amounts to three months of wages for a single vial.
“One company’s greed” – or a more complex situation?
Kalyani Menon-Sen continues to campaign for the affordability of the medication, and summarises the situation thus:
“What was the point of assuring patients that a medicine could save their lives if they couldn’t afford it? It was at this point that the gravity of the situation hit me, where because of one company’s greed, a life-saving drug is kept out of reach for women with cancer. The only motivator for the rapacious pricing policies of Roche and other large pharmaceuticals overseeing the production and distribution of the new cancer drugs is greed,”
The issue however is far more complex, particularly in terms of the legal battles. It revolves around the use of biosimilars, defined as “biotherapeutic products which are similar in terms of quality, safety, and efficacy to already licensed reference biotherapeutic products”. These products, in the case of trastuzumab, will utilise a similar antibody but will be marketed under different names than Roche’s product, sold under the brand name “Herceptin”.
One notable court case in India involves Indian biotech major Biocon in conjunction with US based Mylan. Their brand of trastuzumab, marketed as “CANmab” is the centre of a lawsuit largely centred on the usage of Roche’s clinical data. While Biocon’s product may be cheaper, and thus more accessible in the Indian market, the usage of Roche’s clinical trial data lays out serious questions regarding the drug’s safety and efficacy.
Despite being a biosimilar product, the complexity of an antibody means that even small changes in the manufacturing process can cause changes that may result in the medication being ineffective or unsafe. From a legal point of view, usage of Roche’s clinical data may constitute a breach of copyright laws. More worryingly, the lack of clinical trial data for CANmab may indicate safety testing may be incomplete or entirely absent. If this were the case, the medication would not pass regulations in, for example the EU or US and could be removed from the market.
“Committed to improving access”
Roche have provided a statement regarding the pricing model:
“Roche is committed to improving access to trastuzumab around the world and is working with a number of stakeholders to ensure broad access for cancer patients and to find collaborative solutions to healthcare challenges. Our overall aim is for every person who needs Roche medicines to be able to access and benefit from them.
We have seen this collaborative approach work successfully in many parts of the world for example, Kenya, where Roche and the Kenyan government have collaborated to ensure that breast cancer patients who test positive for the HER2 gene have access to trastuzumab.
Furthermore, to broaden access to our medicines, we have established a number of innovative pricing approaches, such as International Differential Pricing and Personalized Reimbursement Models, to provide more flexibility during pricing negotiations”
In the case of Kenya, a private public partnership between Roche and the Kenya Cancer Association KenCASA have allowed for the creation of the Herceptin Patient Assistance Programme (HPAP). This allows for the purchase of trastuzumab at a subsidised rate for those with HER2+ breast cancer, as well as a third round of treatment provided free for those who purchase the first two.
The approach of private public partnerships may provide a means to reduce the costs in a number of countries. Charity involvement would also be a viable means to reduce costs for patients.
The similarity of the biosimilar products and the often vague laws (varying between countries) surrounding them can cause issues. This topic can be viewed from one of two angles. From the view of the pharmaceutical company, which is protecting its intellectual property, along with the huge investment into the initial work that discovered the drug. Or from a charitable point of view, in which the biosimilars show a potential to bring down prices and so provide better access to the medication.