[Ip-health] Bio-similar of breast cancer drug launched but still out of reach for most, Statement, 20 January, 2014

leena menghaney leenamenghaney at gmail.com
Tue Jan 21 10:29:05 PST 2014

             Campaign for Affordable Trastuzumab

                                              Biosimilar of breast cancer
drug launched but still out of reach for most, 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[1]. 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

[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

August 2013: Press Release, Campaign for Affordable Trastuzumab welcomes
the dismissal of Trastuzumab’s divisional patent applications,

August 2013: Statement, Roche relinquishes Trastuzumab patent in India,
Campaign urges approval of bio-similars,

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,

November 2012: Letter to Indian Prime Minister,

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