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
*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
*
Biocon Press Release is available at http://donttradeourlivesaway.wordpress.com/2014/01/18/biosimilar-of-breast-cancer-drug-trastuzumab-launched-in-india/#more-6897
*
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,
No comments:
Post a Comment