Campaign for Affordable Trastuzumab: Bio-similar of breast cancer drug launched but still out of reach for most

Updated Statement, 20 January, 2014

The Campaign for Affordable Trastuzumab welcomes the announcement that the Indian pharmaceutical company Biocon will now market in India the world’s first bio-similar of the breast cancer drug  trastuzumab.

The marketing of the bio-similar so soon after the removal of patent barriers vindicates our stand in challenging and opposing the secondary patents and divisional patents on trastuzumab sought by Roche in India. We urge patient organisations and civil society groups in other countries to remain vigilant and resist similar attempts by pharma majors to reap unethical profits at the cost of millions of lives.

The bio-similar to be marketed under the brand name of CANMAb is expected to be available in the Indian market from 1 February 2014 and will be sold in 150 milligram or 440 milligram vials.

Announcing the launch of the biosimilar, Ms. Kiran Majumdar-Shaw, CEO Biocon, reiterated her commitment to affordable treatment for Indian women with HER2+ breast cancer.

However, a quick back-of-the-envelope calculation reveals that the introduction of the bio-similar will have little or no impact in terms of expanded access. Many Roche dealers already offer discounts to “steady customers” – patients needing long-term treatment – such that the “street price” of trastuzumab (Herclon[1]) ranges from Rs.55,000/- to Rs.57,000/- for a vial of 440 mg. Biocon’s price for the bio-similar is not significantly lower than what is available from Roche today.

The Roche product (Herceptin) was first marketed in India at Rs.1,20,000/ with the price being reduced to Rs.92,000/- per 440 mg vial soon after the launch of our campaign. The product was later rebranded as Herclon and is currently priced at Rs.75,000/- per 440 mg vial. The price announced by Biocon is approximately Rs. 56,000 per vial of 440 mg according to the company press release which says that the drug will be priced at 25% less than the current reference price charged by Roche[2].

In developed countries, the Roche product is sold in vial sizes of 60 mg, 150 mg, and 440 mg. In India, Roche markets only the 440 mg/vial. Since dosage depends on body weight, a patient weighing say 60 kgs[3] and needing 480 mg per dose, was forced to buy two vials at a time. Biocon’s marketing of the 150 mg will increase the ability of a patient to buy the drug in the amount needed for each dose, rather than raise the money needed for an additional vial of 440 mg.

However, the introduction of the bio-similar will make little or no difference to women whose income is less than Rs.30,000/- per month. For these women – who constitute 75% of the population[4] and include not only the very poor but also the aspiring middle class – CANMAb is as much out of reach as Roche’s Herceptin and Herclon.

Realistically, only families with an income of Rs 75,000/- or more can afford a monthly dose of CANMAb. Such families constitute less than 10% of the population. Biocon’s expectation that the introduction of CANMAb will “expand the patient pool” is therefore unlikely to become reality.

We urge Biocon and its commercial partner – the US pharmaceutical company Mylan Laboratories[5] – to demonstrate their commitment to affordable treatment by bringing the price of CANMAb to below Rs. 1000/- for the 150 mg vial and Rs.5000/- for the 440 mg vial. This will not only give Indian women with HER2+ breast cancer a chance for a healthy and productive life, but will expand the patient pool far beyond the borders of the country and bring relief to the millions of women in developing countries who are battling this disease.

We should not forget that so-called “voluntary price reductions” by pharma companies, couched though they may be in the language of social responsibility, have more to do with securing market dominance than with any concern for patients or their rights. We therefore reiterate our call to the Government of India to take decisive steps to regulate the prices of biologicals (whether originators or biosimilars) like trastuzumab and pegylated interferon that are currently priced out of reach of the majority of those whose lives these drugs can save.

(signed) Kalyani Menon-Sen, Campaign Coordinator

For more information, please contact: Kalyani Menon-Sen +91-9910306382; Leena Menghaney +91-9811365412

[1]Trastuzumab 440 mg from Roche is marketed in India under the brand names Herceptin and Herclon

[2]Biocon Press Release is available at https://donttradeourlivesaway.wordpress.com/2014/01/18/biosimilar-of-breast-cancer-drug-trastuzumab-launched-in-india/#more-6897

[3]In India, the usual protocol for patients with HER+ breast cancer involves intravenous trastuzumab at three-weekly intervals for 12 months (approximately 17 cycles), at an initial loading dose of trastuzumab is 8 mg/kg body weight, followed up with the maintenance dose at 6 mg/kg body weight. A patient weighing 60 kgs will need 480 mg as the loading dose and then 360 mg for the maintenance doses every three weeks.   A patient weighing 65 kgs will need 520 mg as the loaded dose and then 390 mg for the maintenance doses every three weeks.

[4]  Income distribution figures based on NCAER data for 2010

[5]Biocon has a partnership agreement with Mylan for global development & commercialization of trastuzumab

Background documents and updates from the Campaign for Affordable Trastuzumab: 

August 2013: Press Release, Campaign for Affordable Trastuzumab welcomes the dismissal of Trastuzumab’s divisional patent applications, http://infojustice.org/archives/30408

August 2013: Statement, Roche relinquishes Trastuzumab patent in India, Campaign urges approval of bio-similars, http://infojustice.org/archives/30478

January 2013: Compulsory License for Anti-Cancer Drugs – Update from Campaign for Affordable Trastuzumab, http://infojustice.org/archives/28247

March 2013:  Letter to Indian Minister of Commerce, http://kafila.org/2013/03/08/campaign-for-affordable-trastuzumab/

November 2012: Letter to Indian Prime Minister,

https://donttradeourlivesaway.files.wordpress.com/2013/01/letter-to-pm-on-herceptin_final.pdf

 

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4 Responses to Campaign for Affordable Trastuzumab: Bio-similar of breast cancer drug launched but still out of reach for most

  1. b n biswal says:

    india is the population of lower middle class people whose earning is 10,000 to 15,000. Most of the lpwer middle class people are not getting any help from govt or others. it is very difficult to say he/she can afford the medicine.I suggest its availability in janaushid can make easily to purchase lower middle class people.

  2. Virendra Oberoi says:

    Thank you for the campaign. Such collective movements do help. However I would like to make few important points. (1) During little research I did , as I need this injection for my wife , I found that the medicine is available at little lower price, but the attending doctors do not allow one to buy medicine from outside. This forces patient to pay at MRP. (2) Doctors do not share the information about the dose. Depending on the body weight, It may be possible to use use two injections of 150 mg( to get 300 mg dose) . But doctors may not inform & charge patient for 440 mg injection.(3) Focus of such movement should not be limited to talking about poor. Even a middle class person will be financially hard hid by the treatment costs. One should remember that this is a follow on treatment, which means that patient has already undergone Chemotherapy, Surgery & radiation etc which all are quite expensive ( About 7~8 lakhs).Add 12~13 Lakhs for Herclon / CANMAB treatment, total cost of treatment is about 20 Lakhs. What to say about poor, even middle class people find it hard to bear. So total Cancer treatment cost could be focussed.

  3. Nazima Hasan says:

    Sir/Madam,

    My mother also a patient of breast cancer we are a middle class family we can unable to purchase trastuzumab 17 injections for my mothers treatment we purchased 5 injection by very difficulty from mylan company , we got first injection (440+150 mg) others whole injection 400mg precribe by Doctor, we thankful to our Government after by PM fund (released Rs. 300,ooo) the hospital gave only 8 injections by that fund so total 13 injection my mother have but 4 injection left to complete her course, we arrange hardly one injection but now 3 injection left next circle Date is 19 October 2016 please do something for us can you provide us as soon as possible a cheap rate that Trastuzumab injection we need only 3 injection.

    Thanks

  4. Haroon says:

    MRP of Herclon 440 mg is reduced from 75000/- to 50000/-. If the patient does not require 440 mg at a time the balance medicine can be used within 28 days if kept refrigerated.

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