Despite the ongoing speculation over the firm’s future, Actavis was busy in March branching out into new geographies. On 9th March 2009, the firm announced that it had entered the Irish market, with plans that will see the creation of up to 25 new jobs, and on 12th March, the firm and Japan’s ASKA Pharmaceutical signed a legal agreement to establish a joint company in Japan. Despite the headline, Actavis’ arrival in Ireland is not entirely new; a unit was set up there in 2008, and currently employs 11 people. However, Actavis’ presence in Ireland was relatively limited, and the new push will boost Actavis’ operations in the country. The firm aims to quickly ramp up its offering in Ireland in all channels, including hospital-specific, prescription and OTC drugs, and Actavis has stated that it has set double-digit growth targets for its first post-announcement year in the country, with an aim to rapidly expand its sales and marketing team in the coming months. Actavis is keen to play up its economic plus-points, noting in its announcement that its generics offer a reduction of up to 60% on the cost of drugs, ramming home the point by adding that there is a potential to save over 22 million euros (US$28.4 million) on six of the 20 new products it plans to launch in Ireland this year. Adding to the argument, Actavis was able to announce on the same day that it was launching gemcitabine in Ireland, along with other parts of Europe, on the day of patent expiry. This, the firm claims, could create savings in Ireland of 1.8 million euros (US$2.3 million), if all currently gemcitabine sales were switched to Actavis’ generic. However, whether such potential savings could be achieved is debateable; Ireland has low generic drug usage rates, and a government that has not shown much interest in changing this.
The move into Japan is entirely new for Actavis, however, and will see the firm set up business in a country it has had no previous business interests in. The agreement between Actavis and ASKA was first announced in November 2008, when the two firms concluded a preliminary agreement to establish a joint venture, to be called Actavis ASKA. Actavis will be the minority partner in the venture, holding 45% of its stocks, with ASKA holding the 55% stake. Japan has tended to be a somewhat difficult market for generic firms; it is second only to the United States in terms of healthcare spending, but the nation as a whole has always favoured the use of branded pharmaceuticals, with the result that generics have only managed to gain a toehold in the country. However, the situation has potential to change through the Japanese government, which, keen to reduce healthcare costs, introduced a generic substitution measure in April 2008, as part of an ongoing effort to increase generic market share in terms of volume. Although Actavis and ASKA have remained tight-lipped over what products will be marketed, the aim of the joint venture is for ASKA to enter the generics market using Actavis’ portfolio.
Ian Platts - Editor, World Generic Markets
Thursday, March 26, 2009
Friday, March 13, 2009
Biosimilars in the US a step closer?
President Obama has released his budget proposals, including those for the Department of Health and Human Services. The proposal would provide US$76.8 billion to the HHS, whilst the FDA is requesting nearly US$2.4 billion, an increase of 5.7% over the budget that the agency received for the current fiscal year. Not surprisingly, much of the focus on the healthcare aspects of the budget have been on the headline-grabbing issues, such as healthcare reform and the doubling of funding for cancer research. However, another aspect of the budget which deserves attention is its proposal to establish a regulatory pathway to approve generic biologics.
This has long been a thorny issue for the United States with the result that the country has lagged behind the European Union, where a basic approval pathway for biosimilars has been hammered out. Progress on the issue in the US has never been forthcoming, with the opposing sides of the argument clashing on all issues surrounding biosimilars, from their safety and efficacy to the length of data exclusivity periods for biologic products. Whilst none of the parties may have actually said that they do not want biosimilars allowed, the efforts to torpedo any attempt to create a pathway have spoken volumes.
With the new budget proposal specifically seeking to create a regulatory pathway, the question of whether this logjam can be broken has to be asked. President Obama has a focus on healthcare issues in general, with an intention to make the system more cost-effective and widen coverage for more Americans. Mr Obama’s nomination, albeit a second attempt after Tom Daschle, of Kathleen Sebelius, currently the Governor of Kansas, to the post of Secretary of Health and Human Services can be seen to underscore a determination to make changes. Ms Sebelius is a popular Democratic governor in a Republican-dominated state, a position which suggests that bipartisan working has been an essential element of Ms Sebelius’ job, and in turn suggests the same approach will be used should she become the head of the HHS. Thus the job would be taken by somebody with experience in successfully negotiating between staunchly opposed interests, which would surely be essential in any effort to produce a working regulatory pathway for biosimilars. Prior to this nomination, Henry Waxman was voted by the Democratic Caucus to become Chairman of the Committee on Energy and Commerce, which will have oversight on healthcare issues. Mr Waxman has long been known to support establishing a regulatory pathway for biosimilars, and his appointment must surely up the ante.
However, this is an issue which has long confounded its advocates, and whilst the political landscape may have moved to more fertile grounds for creating a pathway, the arguments against it have not been diminished. The issue of biosimilar safety will continue to be a problem, particularly for a litigious nation; entrenched arguments over data exclusivity will not now go away, and the savings through generic biologics will still be pitted against costs to American innovative companies and their employees. The push to create a pathway may have taken one step forward, but there still remains plenty of opportunity for its opponents to claw two steps back.
Ian Platts - Editor, World Generic Markets
This has long been a thorny issue for the United States with the result that the country has lagged behind the European Union, where a basic approval pathway for biosimilars has been hammered out. Progress on the issue in the US has never been forthcoming, with the opposing sides of the argument clashing on all issues surrounding biosimilars, from their safety and efficacy to the length of data exclusivity periods for biologic products. Whilst none of the parties may have actually said that they do not want biosimilars allowed, the efforts to torpedo any attempt to create a pathway have spoken volumes.
With the new budget proposal specifically seeking to create a regulatory pathway, the question of whether this logjam can be broken has to be asked. President Obama has a focus on healthcare issues in general, with an intention to make the system more cost-effective and widen coverage for more Americans. Mr Obama’s nomination, albeit a second attempt after Tom Daschle, of Kathleen Sebelius, currently the Governor of Kansas, to the post of Secretary of Health and Human Services can be seen to underscore a determination to make changes. Ms Sebelius is a popular Democratic governor in a Republican-dominated state, a position which suggests that bipartisan working has been an essential element of Ms Sebelius’ job, and in turn suggests the same approach will be used should she become the head of the HHS. Thus the job would be taken by somebody with experience in successfully negotiating between staunchly opposed interests, which would surely be essential in any effort to produce a working regulatory pathway for biosimilars. Prior to this nomination, Henry Waxman was voted by the Democratic Caucus to become Chairman of the Committee on Energy and Commerce, which will have oversight on healthcare issues. Mr Waxman has long been known to support establishing a regulatory pathway for biosimilars, and his appointment must surely up the ante.
However, this is an issue which has long confounded its advocates, and whilst the political landscape may have moved to more fertile grounds for creating a pathway, the arguments against it have not been diminished. The issue of biosimilar safety will continue to be a problem, particularly for a litigious nation; entrenched arguments over data exclusivity will not now go away, and the savings through generic biologics will still be pitted against costs to American innovative companies and their employees. The push to create a pathway may have taken one step forward, but there still remains plenty of opportunity for its opponents to claw two steps back.
Ian Platts - Editor, World Generic Markets
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