Tuesday, January 21, 2014

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

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 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 of the drug 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[1] 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) 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]  Income distribution figures based on NCAER data for 2010
*Roche does not market the 150 mg/vial in India
* Trastuzumab 440 mg from Roche is marketed in India under the brand names Herceptin and Herclon 
* Biocon has a partnership agreement with Mylan for global development & commercialization of trastuzumab

* 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.  

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,