In September 2009, the regulatory reform for the sale and production of biologic and biosimilar medicines was enforced.
The new regulation establishes the requirements to launch ‘biocomparables’, which is the term chosen in Mexico to define off-patent biologics ‘comparable’ with innovative biologics; other terms such as ‘biosimilars’, ‘biogenerics’ or ‘non original biologics’ are rejected. The new regulation also sets out the creation of a Committee of New Molecules and a Subcommittee of Biologic Medicines to determine, on a case-by-case basis, the clinical or in vitro studies necessary for market registration, depending on the medical use of the product. Once marketed, a pharmacovigilance system will assess these products.
The new regulation represents sizeable opportunities for both local and foreign producers. Local producers such as Probiomed, Silanes and Landsteiner Scientific already produce biologic medicines in Mexico. Competition, however, is expected to arise from foreign producers such as Roche, Amgen, GlaxoSmithKline, Sandoz, Teva and Ranbaxy. On a patient level, the new regulation provides more safety and availability, as the sector had grown in the country without any legal framework.
Further reading - A detailed analysis of the Mexican pharmaceutical market is available from Espicom: The Pharmaceutical Market: Mexico (published January 2010)
Showing posts with label Roche. Show all posts
Showing posts with label Roche. Show all posts
Thursday, 28 January 2010
South Korea - What are the prospects like for South Korea’s biologics/biosimilars market?
South Korea remains an attractive prospect for biologics and biosimilars, with investment from both government and multinationals in this field.
South Korea has a long history in manufacturing biologics. The emergence of a number of Korean companies, including SK Chemicals and Chon Kun Dang, manufacturing generic versions of Roche’s Tamiflu (oseltamivir), indicates that some Korean companies are performing strongly. It also indicates that larger companies in the biosimilar sector have made considerable strides in R&D, manufacturing and distribution in recent years. SK Chemicals, for example, believes that it could have its version of oseltamivir for sale in less than a month after marketing approval is given. This is arguably the result of massive investment in this sector from both government agencies and multinational companies.
First of all, in August 2009 the government announced it had selected two provincial cities, Osong and Daegu, to become sites for high-tech medical-industrial clusters, which are expected to cost around US$5 billion in total. Construction began in 2009 and should be completed by 2012. The government hopes the project will make South Korea a regional pharmaceutical hub like the Boston Bio Cluster in the USA and the Kobe-Osaka-Kyoto triangle in Japan. This was followed by the Swiss pharmaceutical giant Novartis announcing in October 2009 that they will be investing US$100 million into its research division for new drugs whilst also bolstering its biologics manufacturing capabilities. In a deal signed with the MIHWAF, Novartis also announced that they will be providing money for investment in local small-scale biologics manufacturers.
Further reading - A detailed analysis of the South Korean pharmaceutical market is available from Espicom: The Pharmaceutical Market: South Korea (published January 2010)
South Korea has a long history in manufacturing biologics. The emergence of a number of Korean companies, including SK Chemicals and Chon Kun Dang, manufacturing generic versions of Roche’s Tamiflu (oseltamivir), indicates that some Korean companies are performing strongly. It also indicates that larger companies in the biosimilar sector have made considerable strides in R&D, manufacturing and distribution in recent years. SK Chemicals, for example, believes that it could have its version of oseltamivir for sale in less than a month after marketing approval is given. This is arguably the result of massive investment in this sector from both government agencies and multinational companies.
First of all, in August 2009 the government announced it had selected two provincial cities, Osong and Daegu, to become sites for high-tech medical-industrial clusters, which are expected to cost around US$5 billion in total. Construction began in 2009 and should be completed by 2012. The government hopes the project will make South Korea a regional pharmaceutical hub like the Boston Bio Cluster in the USA and the Kobe-Osaka-Kyoto triangle in Japan. This was followed by the Swiss pharmaceutical giant Novartis announcing in October 2009 that they will be investing US$100 million into its research division for new drugs whilst also bolstering its biologics manufacturing capabilities. In a deal signed with the MIHWAF, Novartis also announced that they will be providing money for investment in local small-scale biologics manufacturers.
Further reading - A detailed analysis of the South Korean pharmaceutical market is available from Espicom: The Pharmaceutical Market: South Korea (published January 2010)
Friday, 23 October 2009
UK - Summary of NICE Appraisals in October 2009
NICE Rejects RoActemra for Rheumatoid Arthritis on the NHS
The National Institute for Health and Clinical Excellence (NICE) has issued preliminary guidance rejecting the use of RoActemra (tocilizumab) on the NHS to treat rheumatoid arthritis.
The drug, which is produced by Chugai Pharma and distributed by Roche, has demonstrated its potential benefits to patients in clinical trials. In studies including 4,000 patients, RoActemra, alone or in combination with a disease-modifying anti-rheumatic drug (DMARD), such as methotrexate, significantly reduced the symptoms of rheumatoid arthritis compared to DMARDs alone, regardless of previous therapies and the severity of the disease.
However, NICE has concluded that the drug is not cost-effective, costing £9,295 a year for a patient weighing around 70kg.
The National Rheumatoid Arthritis Society said the guidance means that sufferers’ only options now will be to retry therapies that have already failed or palliative care, which involves large doses of steroids which could cause side effects such as osteoporosis in the longer term.
NICE’s final guidance is due to be issued in February 2010.
NICE Approves Hycamtin for Small Cell Lung Cancer
NICE has approved Hycamtin (topotecan) for patients with small cell lung cancer on the NHS, under certain conditions.
The regulator’s Final Appraisal Determination recommends the use of the drug in patients suffering from a relapse of the disease, but only when treatment with the first-line therapy again is not appropriate, or the combination of cyclophosphamide, vincristine and doxorubicin chemotherapies is contraindicated.
In addition, the oral form of GlaxoSmithKline’s Hycamtin should be used, as the intravenous version is considered too expensive. The cost per cycle for the oral form of Hycamtin is £638, which is equal to an average cost per patient of £2,552, whereas the cost for the intravenous version is £1,495 and £5,980, respectively.
Lung cancer is one of the most common cancers in England, with over 33,000 new cases in England and Wales a year, of which between 10% and 20% are of the small cell type.
In September 2009, Hycamtin was approved by NICE to treat cervical cancer on the NHS (See NICE Approves NHS Use of Hycamtin for Cervical Cancer).
Further reading - A detailed review of the UK pharmaceutical market, including more information on NICE and its appraisal procedures, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
The National Institute for Health and Clinical Excellence (NICE) has issued preliminary guidance rejecting the use of RoActemra (tocilizumab) on the NHS to treat rheumatoid arthritis.
The drug, which is produced by Chugai Pharma and distributed by Roche, has demonstrated its potential benefits to patients in clinical trials. In studies including 4,000 patients, RoActemra, alone or in combination with a disease-modifying anti-rheumatic drug (DMARD), such as methotrexate, significantly reduced the symptoms of rheumatoid arthritis compared to DMARDs alone, regardless of previous therapies and the severity of the disease.
However, NICE has concluded that the drug is not cost-effective, costing £9,295 a year for a patient weighing around 70kg.
The National Rheumatoid Arthritis Society said the guidance means that sufferers’ only options now will be to retry therapies that have already failed or palliative care, which involves large doses of steroids which could cause side effects such as osteoporosis in the longer term.
NICE’s final guidance is due to be issued in February 2010.
NICE Approves Hycamtin for Small Cell Lung Cancer
NICE has approved Hycamtin (topotecan) for patients with small cell lung cancer on the NHS, under certain conditions.
The regulator’s Final Appraisal Determination recommends the use of the drug in patients suffering from a relapse of the disease, but only when treatment with the first-line therapy again is not appropriate, or the combination of cyclophosphamide, vincristine and doxorubicin chemotherapies is contraindicated.
In addition, the oral form of GlaxoSmithKline’s Hycamtin should be used, as the intravenous version is considered too expensive. The cost per cycle for the oral form of Hycamtin is £638, which is equal to an average cost per patient of £2,552, whereas the cost for the intravenous version is £1,495 and £5,980, respectively.
Lung cancer is one of the most common cancers in England, with over 33,000 new cases in England and Wales a year, of which between 10% and 20% are of the small cell type.
In September 2009, Hycamtin was approved by NICE to treat cervical cancer on the NHS (See NICE Approves NHS Use of Hycamtin for Cervical Cancer).
Further reading - A detailed review of the UK pharmaceutical market, including more information on NICE and its appraisal procedures, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)
Thursday, 17 September 2009
UK - NICE Rejects Appeal Over Kidney Cancer Drugs
The National Institute for Health and Clinical Excellence (NICE) has rejected an appeal to make Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus) available on the NHS for patients with renal cancer.
NICE issued guidance on 26th August 2009, which does not recommend Roche’s Avastin, Bayer’s Nexavar and Wyeth’s Torisel as a first-line treatment for advanced and/or metastatic renal cell carcinoma. NICE has also refused approval on the NHS for the use of Nexavar and Sutent (sunitinib) as secondary treatment options.
In August 2008, all four drugs were rejected as first-line treatments, but NICE changed its mind about Pfizer’s Sutent in March 2009, approving it for NHS use. However, NICE still rejected the other three drugs because they were not considered to be a cost effective use of NHS resources. An appeal was lodged against the Final Appraisal Determination by Roche, Wyeth, the James Whale Fund for Kidney Cancer and a joint appeal from Rarer Cancer Forum and Macmillan Cancer Support, but these have not been upheld.
NICE said Avastin costs £,5,982 per patient for the first six-week cycle and £6,117 for subsequent six-week cycles (around £53,000 per patient per year). Nexavar is £2,980.47 for 112 tablets while Torisel costs £620 per vial.
The guidance will be considered for review in June 2011.
Further reading - An in-depth review of the UK pharmaceutical market, including more information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
NICE issued guidance on 26th August 2009, which does not recommend Roche’s Avastin, Bayer’s Nexavar and Wyeth’s Torisel as a first-line treatment for advanced and/or metastatic renal cell carcinoma. NICE has also refused approval on the NHS for the use of Nexavar and Sutent (sunitinib) as secondary treatment options.
In August 2008, all four drugs were rejected as first-line treatments, but NICE changed its mind about Pfizer’s Sutent in March 2009, approving it for NHS use. However, NICE still rejected the other three drugs because they were not considered to be a cost effective use of NHS resources. An appeal was lodged against the Final Appraisal Determination by Roche, Wyeth, the James Whale Fund for Kidney Cancer and a joint appeal from Rarer Cancer Forum and Macmillan Cancer Support, but these have not been upheld.
NICE said Avastin costs £,5,982 per patient for the first six-week cycle and £6,117 for subsequent six-week cycles (around £53,000 per patient per year). Nexavar is £2,980.47 for 112 tablets while Torisel costs £620 per vial.
The guidance will be considered for review in June 2011.
Further reading - An in-depth review of the UK pharmaceutical market, including more information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Friday, 3 July 2009
UK - Roche Withdraws from Industry Association
The British arm of the Swiss company Roche has decided not to renew its membership of the Association of the British Pharmaceutical Industry (ABPI), it was announced in June 2009.
Roche’s move follows a six-month suspension for a serious breach of the ABPI’s code of practice, related to selling its slimming drug Xenical (orlistat) to private clinics. Roche was also criticised for failing to stop a programme which offered incentives for patients to take its treatment for cystic fibrosis, but, in light of the suspension, no further action was taken. The suspension ended in February 2009.
Although Roche has pledged to continue to comply with the ABPI’s Code of Practice, it removes the option for the ABPI to order similar sanctions if the company breaks the code in the future.
The Medicines and Healthcare Regulatory Products Agency (MHRA) can prosecute drug companies, but up until now the majority of disciplinary action has been taken by the Prescription Medicines Code of Practice Authority, run by the ABPI.
In a statement, Roche said: “In line with any commercial business we continually review our operations, and our time away from the ABPI has enabled us to reflect upon the nature of this relationship and consideration of mutual needs in the future. We have concluded that this is something we need to review further and for that reason, we have decided not to re-join the ABPI for the time being. We will continue to review this situation.”
It also noted: “This decision in no way affects our commitment to our working practices and we are still committed to, and will be accountable for, working within the ABPI Code of Practice to ensure compliance with the high standards of our industry.”
The statement also said that a set of new processes and procedures for compliance had been put in place, with a team of eight staff dedicated to compliance, and training is now given to staff so that they fully understand the Code of Practice and the company’s internal policies for complying with it.
However the ABPI, which receives a six-figure subscription from Roche, is disputing the company’s right to leave, and crucially, the decision has raised questions over the organisation’s ability to regulate the industry at arm’s length.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the regulatory environment and the ABPI, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
Roche’s move follows a six-month suspension for a serious breach of the ABPI’s code of practice, related to selling its slimming drug Xenical (orlistat) to private clinics. Roche was also criticised for failing to stop a programme which offered incentives for patients to take its treatment for cystic fibrosis, but, in light of the suspension, no further action was taken. The suspension ended in February 2009.
Although Roche has pledged to continue to comply with the ABPI’s Code of Practice, it removes the option for the ABPI to order similar sanctions if the company breaks the code in the future.
The Medicines and Healthcare Regulatory Products Agency (MHRA) can prosecute drug companies, but up until now the majority of disciplinary action has been taken by the Prescription Medicines Code of Practice Authority, run by the ABPI.
In a statement, Roche said: “In line with any commercial business we continually review our operations, and our time away from the ABPI has enabled us to reflect upon the nature of this relationship and consideration of mutual needs in the future. We have concluded that this is something we need to review further and for that reason, we have decided not to re-join the ABPI for the time being. We will continue to review this situation.”
It also noted: “This decision in no way affects our commitment to our working practices and we are still committed to, and will be accountable for, working within the ABPI Code of Practice to ensure compliance with the high standards of our industry.”
The statement also said that a set of new processes and procedures for compliance had been put in place, with a team of eight staff dedicated to compliance, and training is now given to staff so that they fully understand the Code of Practice and the company’s internal policies for complying with it.
However the ABPI, which receives a six-figure subscription from Roche, is disputing the company’s right to leave, and crucially, the decision has raised questions over the organisation’s ability to regulate the industry at arm’s length.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the regulatory environment and the ABPI, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)
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