Intellectual property issues have been a hot topic for various governments over the last few weeks, with significant developments occurring in Brazil, the Philippines and India. Earlier in April, the Brazil Health Ministry declared the antirretroviral drug tenofovir to be in the ‘public interest’, signalling its willingness to import a generic version of the medicine. The Health Ministry’s declaration indicates that the patent for the drug could be rejected due to its high price; this could then lead to negotiations over the import of a generic version.
At the end of last month, the Philippines also turned against branded manufacturers, with its Congress approving a bill that strongly promotes generic medicines. The new law, which still requires approval from the President, will allow limited parallel importation, should help to prevent incremental innovation, will allow local generic firms to register their versions before patent expiry, and could permit the use of compulsory licences for the public good.
Conversely, one region which has traditionally been without strong intellectual protection laws for years, India, is now looking to clamp down on marketing approvals of drugs already patented. The Drug Controller General of India has published a reference guide and hopes to co-ordinate with the Ministry of Health to create an integrated approach which will link patents together. Following this, the DCGI will then prevent any approvals for generic versions of patented drugs. To date, patent linkage in India has proven difficult, as it has been impeded by a decentralised and inefficient drug approval structure. Unsurprisingly, domestic firms in the country are against such moves, arguing that they will be unworkable in practice.
The motivation behind moves to promote generics through intellectual property reforms are clearly motivated by the high costs of patented drugs. Interestingly, think-tank African Liberty has recently questioned the link, noting that low uptake of drugs was more likely caused by poor infrastructure. Either way, governments in developing countries are likely to continue putting pressure on IP rules, as weakening them in favour of generics appears to provide them with a quicker fix to long term drug expenditure problems.
Jonathan Way - Editor, World Generic Markets
Friday, May 16, 2008
Friday, May 2, 2008
Biosimilars Business Review, April 2008
Europe saw another positive move in February 2008, when the EMEA recommended approval for three GCSF biosimilars. Marketing can begin once the European Commission issues final approval in April 2008. This will mark Teva’s first biosimilar approval in the EU; the company is developing its biosimilar activities apace, as demonstrated by the recently-announced purchase of CoGenesys.
An indication of attitudes to biosimilars in the European marketplace was given by the publication of a report by a UK parliamentary panel into the subject in January. It indicated a general lack of awareness of biosimilars within the Department of Health and the wider health service, and came down strongly against the allowance of substitution. Shortly afterwards, the MHRA issued a brief guidance stating that it is ‘good practice’ to prescribe by brand name only. The parliamentary panel issued a number of other recommendations, none of which will be particularly welcome to the biosimilar industry.
In the USA, the wind has changed, for the time being at least. The running is now being made by the originator industry, which has decided its best interests are served by passing legislation this year rather than delaying; the political environment may be less favourable in 2009. Hence the specific mention of biosimilar regulations in President Bush’s budget request, and the public support given by BIO to the new Barton-Eshoo bill in the House. In contrast, the biosimilar industry has become more cautious, calculating that it can get a better bill after the November 2008 elections. With Congress finely balanced and a real lack of consensus over the issue of market exclusivity, it would be brave indeed to predict the creation of a pathway this year.
Andrew Crofts – Editor, Biosimilars Business Review
An indication of attitudes to biosimilars in the European marketplace was given by the publication of a report by a UK parliamentary panel into the subject in January. It indicated a general lack of awareness of biosimilars within the Department of Health and the wider health service, and came down strongly against the allowance of substitution. Shortly afterwards, the MHRA issued a brief guidance stating that it is ‘good practice’ to prescribe by brand name only. The parliamentary panel issued a number of other recommendations, none of which will be particularly welcome to the biosimilar industry.
In the USA, the wind has changed, for the time being at least. The running is now being made by the originator industry, which has decided its best interests are served by passing legislation this year rather than delaying; the political environment may be less favourable in 2009. Hence the specific mention of biosimilar regulations in President Bush’s budget request, and the public support given by BIO to the new Barton-Eshoo bill in the House. In contrast, the biosimilar industry has become more cautious, calculating that it can get a better bill after the November 2008 elections. With Congress finely balanced and a real lack of consensus over the issue of market exclusivity, it would be brave indeed to predict the creation of a pathway this year.
Andrew Crofts – Editor, Biosimilars Business Review
Europe gets nervous over biosimilar rules
The United Kingdom is currently debating new biosimilar rules, as part of a movement amongst European countries to limit how centralised biosimilar approvals are prescribed. Recommendations put forward include prescription of biosimilars by brand names only, an urgent ban on substitution "until effective safeguards can be relied on", and applying the Medicine and Healthcare Regulatory Authority’s black triangle symbol "be applied to all biosimilar drugs and that, at two-year or other periodic review, that symbol should remain unless the safety evidence is clear that it can be removed".
Changes to prescription rules follow advice from the EMEA in June 2007 that biosimilars cannot be considered identical to their biological reference products. However, while the agency can issue advice, prescription policies are set at a national level; this has led to European countries diluting the strength of the original centralised rules, mainly due to safety fears caused by biosimilar complexity and subtle differences from originator products. According to the European Generic medicines Association (EGA), fifteen countries across Europe have brought in new rules to prevent the automatic substitution of biological medicines by biosimilars, including France, Spain, the Netherlands and Norway.
This contrasts with the approach in the United States, which has not even got so far as creating a biosimilar pathway. However, events in Europe are an indication that the US may also run into difficulties with biosimilar prescription rules following the approval of its own biosimilar legislation. This itself is currently on hold, as a suitable compromise between originator and biosimilar firms has not yet been reached. Interestingly, the forces pushing for legislation sooner have recently been reversed, with the branded industry keen to get a bill through Congress before President Bush leaves office.
The US and European biosimilar agendas are notably different at present, united only by lingering uncertainties remaining in both. This is likely to remain the case in the short term, due to a number of factors such as safety fears and the high costs of producing biological drugs in any form. The boom year for the biosimilar industry will not arrive until 2012 at the earliest, when a much higher proportion of biological drugs start to come off patent. At that time, the financial incentives of promoting biosimilars will be hard for governments to ignore, while experience of biosimilars should lead to more uniformity in safety rules.
Jonathan Way - Editor, World Generic Markets
Changes to prescription rules follow advice from the EMEA in June 2007 that biosimilars cannot be considered identical to their biological reference products. However, while the agency can issue advice, prescription policies are set at a national level; this has led to European countries diluting the strength of the original centralised rules, mainly due to safety fears caused by biosimilar complexity and subtle differences from originator products. According to the European Generic medicines Association (EGA), fifteen countries across Europe have brought in new rules to prevent the automatic substitution of biological medicines by biosimilars, including France, Spain, the Netherlands and Norway.
This contrasts with the approach in the United States, which has not even got so far as creating a biosimilar pathway. However, events in Europe are an indication that the US may also run into difficulties with biosimilar prescription rules following the approval of its own biosimilar legislation. This itself is currently on hold, as a suitable compromise between originator and biosimilar firms has not yet been reached. Interestingly, the forces pushing for legislation sooner have recently been reversed, with the branded industry keen to get a bill through Congress before President Bush leaves office.
The US and European biosimilar agendas are notably different at present, united only by lingering uncertainties remaining in both. This is likely to remain the case in the short term, due to a number of factors such as safety fears and the high costs of producing biological drugs in any form. The boom year for the biosimilar industry will not arrive until 2012 at the earliest, when a much higher proportion of biological drugs start to come off patent. At that time, the financial incentives of promoting biosimilars will be hard for governments to ignore, while experience of biosimilars should lead to more uniformity in safety rules.
Jonathan Way - Editor, World Generic Markets
Teva buys Bentley
Teva Pharmaceutical Industries has agreed to acquire Bentley Pharmaceuticals for US$360 million. US-based Bentley manufactures both branded generic and generic products; its principal market is Spain, though it also sells generic pharmaceuticals in other parts of the EU. These efforts are supported by finished dosage and API manufacturing facilities. Teva noted that it intends to make Bentley's generic pharmaceutical operations serve as the platform on which Teva hopes to build a leading position in Spain.
The Bentley purchase follows a string of investments from Teva in the region. In January, the Israeli manufacturer announced its plans to expand its operations in Hungary, with an investment of US$100 million at its Debrecen site. It then announced in March that it is expanding its operations in Ireland, with a €65 million (US$99.6 million) investment in its existing Waterford facilities in the southeast of the country. Later in the month, meanwhile, Teva’s IVAX unit revealed that it is to spend CZK1 billion (US$60.7 million) to expand its Opava plant in north Moravia, Czech Republic. This aggressive European expansion follows Teva CEO Shlomo Yanai’s recent comments that Teva should double its revenues by 2012; clearly, the new CEO feels that Europe is where the firm’s immediate priorities lie.
Teva’s European expansion is being mirrored by Aurobindo Pharma, which has just announced that it is to purchase the Italian operations of German pharmaceutical company TAD Pharmaceuticals. The TAD Italy purchase is Aurobindo’s third in Europe, following the purchase of Milpharm, and Pharmacin International in 2006 and 2007.
The latest acquisitions correlate with industry insiders’ predictions that a handful of generic manufacturers will lead the drive towards consolidation; Aurobindo will be hoping to be amongst this group, while Teva will certainly feature. Both have adopted a similar strategy of targeting markets where generics are less well established, i.e. Italy and Spain. It will be interesting to see if this tactic is more fruitful than a focus on established markets, where firms have recently been struggling to digest acquisitions.
Jonathan Way - Editor, World Generic Markets
The Bentley purchase follows a string of investments from Teva in the region. In January, the Israeli manufacturer announced its plans to expand its operations in Hungary, with an investment of US$100 million at its Debrecen site. It then announced in March that it is expanding its operations in Ireland, with a €65 million (US$99.6 million) investment in its existing Waterford facilities in the southeast of the country. Later in the month, meanwhile, Teva’s IVAX unit revealed that it is to spend CZK1 billion (US$60.7 million) to expand its Opava plant in north Moravia, Czech Republic. This aggressive European expansion follows Teva CEO Shlomo Yanai’s recent comments that Teva should double its revenues by 2012; clearly, the new CEO feels that Europe is where the firm’s immediate priorities lie.
Teva’s European expansion is being mirrored by Aurobindo Pharma, which has just announced that it is to purchase the Italian operations of German pharmaceutical company TAD Pharmaceuticals. The TAD Italy purchase is Aurobindo’s third in Europe, following the purchase of Milpharm, and Pharmacin International in 2006 and 2007.
The latest acquisitions correlate with industry insiders’ predictions that a handful of generic manufacturers will lead the drive towards consolidation; Aurobindo will be hoping to be amongst this group, while Teva will certainly feature. Both have adopted a similar strategy of targeting markets where generics are less well established, i.e. Italy and Spain. It will be interesting to see if this tactic is more fruitful than a focus on established markets, where firms have recently been struggling to digest acquisitions.
Jonathan Way - Editor, World Generic Markets
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