$10 Copy of Gilead Blockbuster Sovaldi Appears in Bangladesh
Jaded said
Mar 29, 2015
Tig56 wrote:
Hi Jaded,
I agree with Malcolm that caution with these unregulated generics is warranted. I see in your article that these particular copies are being studied for efficacy and quality by the WHO and others, so that will tell us a lot. Thanks for the information. It's always good to stay up to date on all of this.
Have you heard anything from your doctor regarding your chance to receive the new treatment this year? I hope you get a favorable response soon. That would be great news indeed!
Tig
I will be seeing him tomorrow but exchanged a few emails since. He was quite reassuring that I would receive treatment...the word he used was "imminently". It seems that figure of 1500 people (which btw only was in reference to my Province...not all of Canada) was an estimate but in fact there is no cap of the amount to be treated and according to him 1500 is more people treated than in previous years. So all looks well...thx for asking.
Yes I think it would be better to wait as the Generic from India is supposed to be available in a few months but WHO is already involved with Incepta ...it wont be some underground drug made in someones basement.
Tig said
Mar 29, 2015
Hi Jaded,
I agree with Malcolm that caution with these unregulated generics is warranted. I see in your article that these particular copies are being studied for efficacy and quality by the WHO and others, so that will tell us a lot. Thanks for the information. It's always good to stay up to date on all of this.
Have you heard anything from your doctor regarding your chance to receive the new treatment this year? I hope you get a favorable response soon. That would be great news indeed!
Tig
Jaded said
Mar 29, 2015
In the not to distant future a relatively inexpensive generic will be available in so many countries. If need be I would go to Thailand where one can live relatively cheap for 3 months and take my chances rather than wait until it's too late to be treated here.
I wonder what effect if any this will have on the price of these drugs in the future. Many people still won't be able to afford to travel but many people who can't get reimbursed for the the drug or can't afford to pay out of pocket for it CAN afford say $1200 round-trip airfare and the $500 a month cost of living in Thailand plus $900 for the treatment.
-- Edited by Jaded on Sunday 29th of March 2015 06:53:33 AM
mallani said
Mar 28, 2015
Thanks, Jaded.
I would be wary of a non-regulated generic Sovaldi from Bangladesh. I'd wait for an approved generic from a reputable company like Cipla.
Good to see this drug becoming available in the poorer countries. Cheers.
Jaded said
Mar 28, 2015
(Bloomberg) -- A $10 version of Sovaldi, the Gilead Sciences Inc. hepatitis C treatment that sells for $1,000 a pill in the U.S., is now available in Bangladesh and could make its way to other parts of the world where the U.S. company doesnt have patents.
Incepta Pharmaceuticals Ltd. doesnt have a license from Gilead and its version was launched last month, said Managing Director Abdul Muktadir. The company also aims to sell the drug overseas, including to parts of Southeast Asia and Africa.
The generic drugmaker has beaten to the market a number of larger Indian competitors that were licensed by Gilead to produce low-cost versions of Sovaldi for 91 countries that are mostly poor. Nations not covered by Gileads license, including Thailand, Malaysia and Morocco, and countries where Sovaldi isnt patented could benefit from the new source of cheap copies.
Inceptas price of about $900 for 12 weeks is the same price at which Gilead will offer its branded version of the drug in India. Even so, the Bangladeshi version shows the challenge facing Gilead from companies it doesnt have agreements with in countries where the drug isnt patented.
The World Health Organization said it is in talks with Incepta for its prequalification programme, which assesses drug quality. International aid agencies and countries look to this WHO certification as a reference when picking drugs for bulk purchases.
Gilead is aware of unauthorized generic versions of sofosbuvir being offered in the marketplace, the company said in an e-mail. Were focused on enabling our eleven Indian generic partners to launch their authorized generic versions as soon as possible.
Marketplace
Under a World Trade Organization agreement, Bangladesh, as one of the worlds least developed countries, doesnt have to protect pharmaceutical patents.
In the U.S., Sovaldi has sparked a backlash from commercial health insurers because of its cost of $84,000 for a 12-week course of treatment. In the rest of the world, the price of the drug is already set to plunge as Gileads licensees start selling.
Hyderabad-based Natco Pharma Ltd., one of Gileads licensees, launched its generic sofosbuvir in Nepal this month. Natco in a statement Monday said it had priced its generic medicine at 19,900 rupees ($318) for a bottle of 28 tablets in Nepal.
A number of other Sovaldi generics besides Inceptas, also not authorized by Gilead, are in the works in Egypt, according to the Egyptian Initiative for Personal Rights.
The WHO is in talks with Incepta along with a handful of companies in India and Egypt on pre-qualification of Sovaldi generics, said Peter Beyer, senior advisor in WHOs department of essential medicines and health products in Geneva.
Dhaka-based Incepta is currently preparing quality and dissolution studies on its version of sofosbuvir to submit in support of its international applications, Muktadir said.
We are just a little ahead of them, said Muktadir of his Indian competitors. So, maybe we should be able to launch these products wherever it is required. In some countries in Africa, and some of the Southeast Asian countries where the burden is very high -- these are the countries we are looking at.
Inceptas sofosbuvir is approved for sale by the Bangladeshi drug regulator, said Mohammad Salahuddin, assistant director at the Directorate General of Drug Administration.
Generic Competitors
Gileads hepatitis drugs, including Sovaldi and the related pill Harvoni which combines Sovaldi with another drug, have transformed the way liver infection is treated, with most patients being cured after a 12-week course.
Nearly a dozen Indian manufacturers are part of Gileads licensing pact for low-income countries, including Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd. and Natco.
I think everybody is very excited about this product because it offers such a wonderful treatment option, Muktadir said. But the price is going to come down, and the treatment regimen is only for three months. So, I dont think its going to be a big money-earner.
Sovaldi was Gileads top-selling product last year, bringing in $10.3 billion in sales for the Foster City, California-based company.
Inceptas copy of Sovaldi, called Hopetavir, is aimed more for international markets than Bangladesh, where hepatitis C prevalence is low, though there is no reliable nationwide data, Muktadir said.
Founded in 1999, Incepta has more than 600 products approved for sale in Bangladesh, ranging from oral solid pills to injectable human insulin, according to the companys website. The company exports products to more than 40 countries, mostly less regulated markets like Mongolia, Kenya, Somalia, Ethiopia, Mauritania, Democratic Republic of Congo and Afghanistan. It also sells to more regulated markets such as Finland, the U.K., Ukraine and Turkey, according to the site.
Affordable Sources
Doctors Without Borders is searching for affordable, quality assured sources of sofosbuvir, said Rohit Malpani, director of policy and analysis at the Access Campaign in Paris. The aid agency can purchase products approved by stringent country regulators or by the WHO, he said.
The majority of the worlds hepatitis C sufferers live in middle-income countries, which carry approximately 73 percent of the world burden, according to Doctors Without Borders.
Brazil, home to 2.6 million people with hepatitis C, Thailand, with 1.5 million patients, and Morocco, with 625,000 patients, are all nations not included in Gileads agreement with the Indian generics companies.
I'm not sure what the ruling is in various countries about bringing med's home but this may be worth the price of 3 month stay for those without affordable alternatives.
-- Edited by Jaded on Sunday 29th of March 2015 06:15:31 AM
I will be seeing him tomorrow but exchanged a few emails since. He was quite reassuring that I would receive treatment...the word he used was "imminently". It seems that figure of 1500 people (which btw only was in reference to my Province...not all of Canada) was an estimate but in fact there is no cap of the amount to be treated and according to him 1500 is more people treated than in previous years. So all looks well...thx for asking.
Yes I think it would be better to wait as the Generic from India is supposed to be available in a few months but WHO is already involved with Incepta ...it wont be some underground drug made in someones basement.
Hi Jaded,
I agree with Malcolm that caution with these unregulated generics is warranted. I see in your article that these particular copies are being studied for efficacy and quality by the WHO and others, so that will tell us a lot. Thanks for the information. It's always good to stay up to date on all of this.
Have you heard anything from your doctor regarding your chance to receive the new treatment this year? I hope you get a favorable response soon. That would be great news indeed!
Tig
In the not to distant future a relatively inexpensive generic will be available in so many countries. If need be I would go to Thailand where one can live relatively cheap for 3 months and take my chances rather than wait until it's too late to be treated here.
I wonder what effect if any this will have on the price of these drugs in the future. Many people still won't be able to afford to travel but many people who can't get reimbursed for the the drug or can't afford to pay out of pocket for it CAN afford say $1200 round-trip airfare and the $500 a month cost of living in Thailand plus $900 for the treatment.
-- Edited by Jaded on Sunday 29th of March 2015 06:53:33 AM
Thanks, Jaded.
I would be wary of a non-regulated generic Sovaldi from Bangladesh. I'd wait for an approved generic from a reputable company like Cipla.
Good to see this drug becoming available in the poorer countries. Cheers.
(Bloomberg) -- A $10 version of Sovaldi, the Gilead Sciences Inc. hepatitis C treatment that sells for $1,000 a pill in the U.S., is now available in Bangladesh and could make its way to other parts of the world where the U.S. company doesnt have patents.
Incepta Pharmaceuticals Ltd. doesnt have a license from Gilead and its version was launched last month, said Managing Director Abdul Muktadir. The company also aims to sell the drug overseas, including to parts of Southeast Asia and Africa.
The generic drugmaker has beaten to the market a number of larger Indian competitors that were licensed by Gilead to produce low-cost versions of Sovaldi for 91 countries that are mostly poor. Nations not covered by Gileads license, including Thailand, Malaysia and Morocco, and countries where Sovaldi isnt patented could benefit from the new source of cheap copies.
Inceptas price of about $900 for 12 weeks is the same price at which Gilead will offer its branded version of the drug in India. Even so, the Bangladeshi version shows the challenge facing Gilead from companies it doesnt have agreements with in countries where the drug isnt patented.
The World Health Organization said it is in talks with Incepta for its prequalification programme, which assesses drug quality. International aid agencies and countries look to this WHO certification as a reference when picking drugs for bulk purchases.
Gilead is aware of unauthorized generic versions of sofosbuvir being offered in the marketplace, the company said in an e-mail. Were focused on enabling our eleven Indian generic partners to launch their authorized generic versions as soon as possible.
Marketplace
Under a World Trade Organization agreement, Bangladesh, as one of the worlds least developed countries, doesnt have to protect pharmaceutical patents.
In the U.S., Sovaldi has sparked a backlash from commercial health insurers because of its cost of $84,000 for a 12-week course of treatment. In the rest of the world, the price of the drug is already set to plunge as Gileads licensees start selling.
Hyderabad-based Natco Pharma Ltd., one of Gileads licensees, launched its generic sofosbuvir in Nepal this month. Natco in a statement Monday said it had priced its generic medicine at 19,900 rupees ($318) for a bottle of 28 tablets in Nepal.
A number of other Sovaldi generics besides Inceptas, also not authorized by Gilead, are in the works in Egypt, according to the Egyptian Initiative for Personal Rights.
The WHO is in talks with Incepta along with a handful of companies in India and Egypt on pre-qualification of Sovaldi generics, said Peter Beyer, senior advisor in WHOs department of essential medicines and health products in Geneva.
Dhaka-based Incepta is currently preparing quality and dissolution studies on its version of sofosbuvir to submit in support of its international applications, Muktadir said.
We are just a little ahead of them, said Muktadir of his Indian competitors. So, maybe we should be able to launch these products wherever it is required. In some countries in Africa, and some of the Southeast Asian countries where the burden is very high -- these are the countries we are looking at.
Inceptas sofosbuvir is approved for sale by the Bangladeshi drug regulator, said Mohammad Salahuddin, assistant director at the Directorate General of Drug Administration.
Generic Competitors
Gileads hepatitis drugs, including Sovaldi and the related pill Harvoni which combines Sovaldi with another drug, have transformed the way liver infection is treated, with most patients being cured after a 12-week course.
Nearly a dozen Indian manufacturers are part of Gileads licensing pact for low-income countries, including Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd. and Natco.
I think everybody is very excited about this product because it offers such a wonderful treatment option, Muktadir said. But the price is going to come down, and the treatment regimen is only for three months. So, I dont think its going to be a big money-earner.
Sovaldi was Gileads top-selling product last year, bringing in $10.3 billion in sales for the Foster City, California-based company.
Inceptas copy of Sovaldi, called Hopetavir, is aimed more for international markets than Bangladesh, where hepatitis C prevalence is low, though there is no reliable nationwide data, Muktadir said.
Founded in 1999, Incepta has more than 600 products approved for sale in Bangladesh, ranging from oral solid pills to injectable human insulin, according to the companys website. The company exports products to more than 40 countries, mostly less regulated markets like Mongolia, Kenya, Somalia, Ethiopia, Mauritania, Democratic Republic of Congo and Afghanistan. It also sells to more regulated markets such as Finland, the U.K., Ukraine and Turkey, according to the site.
Affordable Sources
Doctors Without Borders is searching for affordable, quality assured sources of sofosbuvir, said Rohit Malpani, director of policy and analysis at the Access Campaign in Paris. The aid agency can purchase products approved by stringent country regulators or by the WHO, he said.
The majority of the worlds hepatitis C sufferers live in middle-income countries, which carry approximately 73 percent of the world burden, according to Doctors Without Borders.
Brazil, home to 2.6 million people with hepatitis C, Thailand, with 1.5 million patients, and Morocco, with 625,000 patients, are all nations not included in Gileads agreement with the Indian generics companies.
http://www.bloomberg.com/news/articles/2015-03-08/-10-copy-of-gilead-s-blockbuster-sovaldi-appears-in-bangladesh
I'm not sure what the ruling is in various countries about bringing med's home but this may be worth the price of 3 month stay for those without affordable alternatives.
-- Edited by Jaded on Sunday 29th of March 2015 06:15:31 AM