The Federal Trade Commission released a report on 10th June 2009 investigating the potential effects of follow-on biologic drug competition. The report concluded that developing a regulatory pathway to allow follow-on biologics would be an efficient way to bring lower-priced drugs to the market; this is not the most surprising conclusion that could be reached. However, the report did find that even with such a pathway, the competitive market between pioneer biologics and follow-on biologics would not be likely to follow the same course as the competitive market between branded and generic small molecule drugs, as fostered by the Hatch-Waxman Act. Follow-on biologics would be unlikely to enter the market for products with annual revenues less than US$250 million, and it would be likely that only two or three generic manufacturers would attempt entry for a given pioneer drug. Furthermore, given the costs involved in producing a follow-on product, drugs would be introduced with discounts no larger than between 10% and 30% of the pioneer’s product price. As a result, the pioneer could still expect to retain between 70% and 90% of market share, a far cry from the situation with traditional drugs, when generic entry can reduce market share by similar percentages as the FTC is estimating will be retained.
In that respect, the report does not seem to contain much bad news for the biologic drug industry. However, the industry’s association, BIO, responded to the report by saying that at first glance it was fundamentally flawed, and demonstrating a lack of understanding of the conditions necessary to drive biomedical innovation. This seems a somewhat surprising response to a report that suggests generic competition would not be as damaging to profits for the biologic industry as it has been for traditional medicines, with few competitors and relatively small price discounts. However, the cause of most concern may well reside in the report’s argument that a 12 to 14 year regulatory exclusivity period, as recommended in one of two bills in Congress attempting to create a regulatory pathway for follow-on biologics, would be too long to promote innovation. This appears to be a sticking point for BIO, which argues that even with the limited generic competition suggested by the report, other studies show that pioneer companies would be unable to recoup their costs without a 12 to 14 year exclusivity period. BIO claims to support the development of a regulatory pathway for follow-on biologics, and with two competing bills currently going through Congress to create a pathway, the question is more and more ‘when’ rather than ‘if’. However, as BIO’s response to this report shows, the biologic industry is determined over what form of pathway it will tolerate. The question will be how well the industry will fare in convincing Congress to agree with it.
Ian Platts - Editor, World Generic Markets
Friday, June 19, 2009
Friday, June 12, 2009
Sandoz acquires Ebewe; Pfizer expands generics agreements
Sandoz’ parent company, Novartis, announced on 20th May 2009 that it was to acquire the specialty generic injectables business of Ebewe Pharma, which would provide Sandoz an opportunity to create a global platform for future growth whilst improving access for patients worldwide to many generic oncology medicines. Under the terms of the deal, Novartis will acquire the business for 925 million euros (US$1.3 billion) in cash; the deal will exclude Ebewe’s separate injectable neurological products business. Sandoz is currently the second largest generic firm in the world, but still some way behind Teva Pharmaceutical Industries in terms of sales. According to Novartis, Ebewe Pharma’s net sales in 2008 were worth 188 million euros (US$267 million), so this acquisition is unlikely to see Sandoz push ahead past Teva. However, this is the firm’s first acquisition in a number of years, which must underline the firm’s belief that Ebewe represents a significant strategic fit.
Ebewe Pharma was founded in Vienna, Austria, in 1934, but relocated its headquarters to Unterach, Austria, in 1945. Between 1956 and 2001, it acted as an affiliate of the BASF Group, and also briefly for Abbott. However, in 2001, the company again became independent. The company specialises in technologies and applications in the fields of specialty pharmaceuticals, neurological products and contract manufacturing. With regard to its specialty products, the firm has focused on the categories of oncology and immunology, and claims to be one of the leading suppliers of parenteral specialty pharmaceuticals. Ebewe has research centres in Austria and the US, and the firm claims that in the area of oncology it offers one of the widest product lines in the industry. Ebewe sells its specialty pharmaceuticals through a network of 20 Ebewe country organisations as well as business partners in over 80 countries. The firm has had nine ANDAs approved in the US recently, between December 2007 and April 2009, with most of them being either CNS drugs or oncology drugs, including paclitaxel and methotrexate sodium.
Separately, but on the same day, Pfizer announced plans to expand its generics portfolio through two agreements with the Indian firm, Aurobindo Pharma and Claris Lifesciences. Pfizer previously entered into agreements with Aurobindo in July 2008 and March 2009, and this latest announcement effectively extends those into new areas. However, the agreement with Claris is new. Under the terms of the agreement, Pfizer has acquired the rights to 15 injectable products covering a number of therapeutic categories, including pain management and anti-infectives. Claris focuses on the production of injectables and claims a presence in over 76 countries. As with Ebewe, Claris has been active in the US generics market in recent years, gaining four ANDA approvals in March and April 2008 for ondansetron, ciprofloxacin and metronidazole. These agreements are an interesting move for Pfizer, which, although has a generics subsidiary in the form of Greenstone, has tended to be more averse to the generics industry than other branded pharmaceutical firms. Pfizer’s keenness to develop its presence in the generics market perhaps reflects difficulties the firm has seen with the branded industry in recent years. Although it has retained its position as the leading branded firm, Pfizer’s sales have been flat for the last few years, with increased generic competition for some of its key products sapping sales.
Ian Platts - Editor, World Generic Markets
Ebewe Pharma was founded in Vienna, Austria, in 1934, but relocated its headquarters to Unterach, Austria, in 1945. Between 1956 and 2001, it acted as an affiliate of the BASF Group, and also briefly for Abbott. However, in 2001, the company again became independent. The company specialises in technologies and applications in the fields of specialty pharmaceuticals, neurological products and contract manufacturing. With regard to its specialty products, the firm has focused on the categories of oncology and immunology, and claims to be one of the leading suppliers of parenteral specialty pharmaceuticals. Ebewe has research centres in Austria and the US, and the firm claims that in the area of oncology it offers one of the widest product lines in the industry. Ebewe sells its specialty pharmaceuticals through a network of 20 Ebewe country organisations as well as business partners in over 80 countries. The firm has had nine ANDAs approved in the US recently, between December 2007 and April 2009, with most of them being either CNS drugs or oncology drugs, including paclitaxel and methotrexate sodium.
Separately, but on the same day, Pfizer announced plans to expand its generics portfolio through two agreements with the Indian firm, Aurobindo Pharma and Claris Lifesciences. Pfizer previously entered into agreements with Aurobindo in July 2008 and March 2009, and this latest announcement effectively extends those into new areas. However, the agreement with Claris is new. Under the terms of the agreement, Pfizer has acquired the rights to 15 injectable products covering a number of therapeutic categories, including pain management and anti-infectives. Claris focuses on the production of injectables and claims a presence in over 76 countries. As with Ebewe, Claris has been active in the US generics market in recent years, gaining four ANDA approvals in March and April 2008 for ondansetron, ciprofloxacin and metronidazole. These agreements are an interesting move for Pfizer, which, although has a generics subsidiary in the form of Greenstone, has tended to be more averse to the generics industry than other branded pharmaceutical firms. Pfizer’s keenness to develop its presence in the generics market perhaps reflects difficulties the firm has seen with the branded industry in recent years. Although it has retained its position as the leading branded firm, Pfizer’s sales have been flat for the last few years, with increased generic competition for some of its key products sapping sales.
Ian Platts - Editor, World Generic Markets
Friday, May 29, 2009
FDA releases budget request as GPhA shows generic savings
On 7th May 2009, the FDA announced its budget request for fiscal year 2010. The agency has requested a budget of US$3.2 billion overall, representing an increase of 19% over the current FDA fiscal year budget. Much of the request focuses on two major initiatives for FY2010: Protecting America’s Food Supply and Safer Medical Products. However, the request also includes proposals for four new user fees; one of these relates to generic drugs. The issue of introducing generic drug user fees has been around for a while, and the Generic Pharmaceutical Association (GPhA) responded to the proposal with the same views it has expressed when the issue has come round before. The organisation commented that the generic industry is open to user fees, but with the caveat that there would need to be guarantees that the fees would aid in the timely review and approval of generic applications.
Specifically, the GPhA has identified what it considers to be core issues, which it claims have been around for over a decade. These include the citizen petition process, scientific, regulatory and legal consultations, enhanced communication, more inspection resources and the accountability and structure of the Office of Generic Drugs (OGD). The organisation cites as an example that in 2007, the brand industry held 2,200 meetings with the FDA, yet the generic industry had only seven meetings, making the argument that unless the FDA and the industry communicate more effectively, generics will not get to consumers faster. The organisation added that generic applications that are subject to scientific, regulatory or legal consults can remain stuck in limbo for months, if not years, which again results in products being delayed entry to the market. The GPhA has acknowledged that the FDA needs more resources to review and approve generics, but argues that increasing resources alone will not help; instead, the agency also needs to tackle the underlying problem of timely consumer access. For its part, the FDA has released figures which show that the Center for Drug Evaluation and Research (CDER) has seen a dramatic increase in its workload, with the number of ANDAs almost doubling over the past five years, whilst its staffing levels have increased at a much slower rate. In FY2008, CDER approved or tentatively approved 598 applications, and received 830 ANDAs. This compared to 310 approvals or tentative approvals and 307 receipts in FY2001. Interestingly, the number of receipts in FY2008 was down slightly, compared to the 880 received in FY2007, marking the first dip since before FY2001.
It can surely be no coincidence that on the same day that the FDA released its budget request, the GPhA also released details of a report it commissioned from IMS Health showing that generics had saved the American healthcare system more than US$734 billion in the last decade. The report also showed around US$121 billion was saved in 2008 alone. The report was commissioned as part of efforts to mark the 25th anniversary of the passing of the Hatch-Waxman Act, but the timing and its message that generics save money, seems to be more aimed at pushing for an increase of funding for the FDA’s generic drugs function. Preferably, it seems, through tax money rather than user fees from the industry.
Ian Platts - Editor, World Generic Markets
Specifically, the GPhA has identified what it considers to be core issues, which it claims have been around for over a decade. These include the citizen petition process, scientific, regulatory and legal consultations, enhanced communication, more inspection resources and the accountability and structure of the Office of Generic Drugs (OGD). The organisation cites as an example that in 2007, the brand industry held 2,200 meetings with the FDA, yet the generic industry had only seven meetings, making the argument that unless the FDA and the industry communicate more effectively, generics will not get to consumers faster. The organisation added that generic applications that are subject to scientific, regulatory or legal consults can remain stuck in limbo for months, if not years, which again results in products being delayed entry to the market. The GPhA has acknowledged that the FDA needs more resources to review and approve generics, but argues that increasing resources alone will not help; instead, the agency also needs to tackle the underlying problem of timely consumer access. For its part, the FDA has released figures which show that the Center for Drug Evaluation and Research (CDER) has seen a dramatic increase in its workload, with the number of ANDAs almost doubling over the past five years, whilst its staffing levels have increased at a much slower rate. In FY2008, CDER approved or tentatively approved 598 applications, and received 830 ANDAs. This compared to 310 approvals or tentative approvals and 307 receipts in FY2001. Interestingly, the number of receipts in FY2008 was down slightly, compared to the 880 received in FY2007, marking the first dip since before FY2001.
It can surely be no coincidence that on the same day that the FDA released its budget request, the GPhA also released details of a report it commissioned from IMS Health showing that generics had saved the American healthcare system more than US$734 billion in the last decade. The report also showed around US$121 billion was saved in 2008 alone. The report was commissioned as part of efforts to mark the 25th anniversary of the passing of the Hatch-Waxman Act, but the timing and its message that generics save money, seems to be more aimed at pushing for an increase of funding for the FDA’s generic drugs function. Preferably, it seems, through tax money rather than user fees from the industry.
Ian Platts - Editor, World Generic Markets
Thursday, May 14, 2009
Ontario government takes action against generic firms
In late April, the Ontario government’s Ministry of Health and Long-Term Care announced it was taking legal action against seven generic firms, along with a number of pharmacies and wholesalers, for allegedly massaging professional allowances by re-selling drugs. Professional allowances are monies that generic drug manufacturers pay pharmacies for buying their prescription drug products, and the Ontario government has alleged that a number of firms were involved in a scheme whereby pharmacies bought greater stocks than they needed, claiming the monies against the stock, then returning what was not needed to wholesalers, which then also claimed monies for the returned stock. The seven companies involved included Taro Pharmaceuticals, Cobalt Pharmaceuticals, Genpharm, Teva’s subsidiary, Novopharm, Pharmascience, Sandoz Canada and ratiopharm. In total, the seven received Rebate Penalty Orders worth C$3.5 million (US$3.0 million), with Taro penalised the least, at C$22,512.68, and Genpharm and Novopharm the most, at C$1,791,957.71 and C$1,202,958.88, respectively.
The Ontario government explained that the professional allowances system had been shaken up as part of changes made by Bill 102 to the legislation that governs Ontario’s publicly funded drug programmes. For the Ontario Drug Benefit market, manufacturers could provide and pharmacies receive up to 20% of generic drug product sales per pharmacy in professional allowances. The allowances must then be used for activities outlined in the regulations, such as patient care that benefits customers. There was no limit on the amount of professional allowances relating to the private market. Drug manufacturers are required to report to the Ministry of Health and Long-Term Care the amount of professional allowances paid, and pharmacies the amount received. Pharmacies are also required to report on how the allowances are spent. Any professional allowance payment not meeting the regulated requirements would be regarded as a rebate, and prohibited. The Ministry reviewed these reports and found discrepancies between the figures being given by generic firms and those being given by pharmacies, and this led to a series of audits being carried out at 14 locations, including three generic drug firms, five wholesalers and six pharmacies.
According to local reports, manufacturers claimed to have paid C$332 million (US$284 million) in rebates, whilst pharmacies claimed to have received only C$145 million (US$124 million). In view of this, the decision to fine the seven generic firms just C$3.5 million in total and all parties involved C$33.8 million (US$28.9 million) surely does not serve as much of a disincentive.
Ian Platts - Editor, World Generic Markets
The Ontario government explained that the professional allowances system had been shaken up as part of changes made by Bill 102 to the legislation that governs Ontario’s publicly funded drug programmes. For the Ontario Drug Benefit market, manufacturers could provide and pharmacies receive up to 20% of generic drug product sales per pharmacy in professional allowances. The allowances must then be used for activities outlined in the regulations, such as patient care that benefits customers. There was no limit on the amount of professional allowances relating to the private market. Drug manufacturers are required to report to the Ministry of Health and Long-Term Care the amount of professional allowances paid, and pharmacies the amount received. Pharmacies are also required to report on how the allowances are spent. Any professional allowance payment not meeting the regulated requirements would be regarded as a rebate, and prohibited. The Ministry reviewed these reports and found discrepancies between the figures being given by generic firms and those being given by pharmacies, and this led to a series of audits being carried out at 14 locations, including three generic drug firms, five wholesalers and six pharmacies.
According to local reports, manufacturers claimed to have paid C$332 million (US$284 million) in rebates, whilst pharmacies claimed to have received only C$145 million (US$124 million). In view of this, the decision to fine the seven generic firms just C$3.5 million in total and all parties involved C$33.8 million (US$28.9 million) surely does not serve as much of a disincentive.
Ian Platts - Editor, World Generic Markets
Tuesday, April 14, 2009
Congress pushes for biosimilars pathway
March 2009 saw the US Congress turn its attention to the issue of creating a regulatory pathway for biosimilars (see p. 11). However, two competing visions have emerged, both originating in the House of Representatives, and predictably, one is favoured by the generics industry whilst the other is favoured by the biotech industry. First out of the blocks was a bipartisan bill, H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act, introduced by Henry Waxman, Nathan Deal, Frank Pallone and Jo Ann Emerson. With Mr Waxman‟s name on the bill, it is no surprise that the generic industry favour this bill. However, within days, a second bill, H.R. 1548, the Pathway for Biosimilars Act, was introduced, again by a bipartisan group of representatives, including Anna Eshoo, Jay Inslee and Joe Barton. This bill has won the approval of BIO.
Both bills are broadly similar, basically attempting to set out a regulatory pathway on the same lines as the Hatch-Waxman Act. However, there is one essential difference between the two: H.R. 1427 gives original biologics five years of exclusivity, with certain modifications of existing drugs getting three years. These periods can be extended for up to a year. Meanwhile, H.R. 1548 provides up to 14 ½ years of data exclusivity for new biologics. It is clear why the generics industry would favour one bill whilst the biologic industry would favour the other. This also suggests the two competing bills are the result of lobbying by the various industry interests. This is backed up by the fact that Representative Inslee represents a Seattle-area district with a strong biotech sector. In addition, Mr Inslee also serves on the House Energy and Commerce Committee, as does Ms Eshoo and Mr Barton, who is the ranking member of the committee. However, the committee is chaired by Mr Waxman, who can also call on support from his cosponsors, Mr Pallone and Mr Deal, so clearly the two bills will be the subject of considerable debate. How the two bills fare in the committee stage will be an interesting battle of wills.
Outside of Congress, the various proponents and opponents of the two bills have shown differing approaches in how they are trying to sell their arguments. BIO has said that it has safety concerns over H.R. 1427, whilst applauds the alternative bill, H.R. 1548, for being safer. However, it seems likely that BIO‟s more immediate concern is over the length of data protection, which is a legitimate concern for the industry, but not necessarily one that will fly with the general public. BIO also expresses concern that H.R. 1427 would jeopardise biotech jobs, noting that the industry supports 7.5 million jobs in America, with these jobs generally being highly paid, and therefore good contributors to the economy. Conversely, the GPhA also uses the economy angle in its support of H.R. 1427, arguing that the bill would help the economy by strengthening healthcare whilst reducing costs to the public. The GPhA adds that the bill is supported by consumer, business and labour organisations. Both sides recognise that a regulatory pathway for biosimilars is inevitable. However, what shape that legislation will ultimately take is less clear, and will seemingly depend on political skills and an ability to convince public opinion.
Ian Platts - Editor, World Generic Markets
Both bills are broadly similar, basically attempting to set out a regulatory pathway on the same lines as the Hatch-Waxman Act. However, there is one essential difference between the two: H.R. 1427 gives original biologics five years of exclusivity, with certain modifications of existing drugs getting three years. These periods can be extended for up to a year. Meanwhile, H.R. 1548 provides up to 14 ½ years of data exclusivity for new biologics. It is clear why the generics industry would favour one bill whilst the biologic industry would favour the other. This also suggests the two competing bills are the result of lobbying by the various industry interests. This is backed up by the fact that Representative Inslee represents a Seattle-area district with a strong biotech sector. In addition, Mr Inslee also serves on the House Energy and Commerce Committee, as does Ms Eshoo and Mr Barton, who is the ranking member of the committee. However, the committee is chaired by Mr Waxman, who can also call on support from his cosponsors, Mr Pallone and Mr Deal, so clearly the two bills will be the subject of considerable debate. How the two bills fare in the committee stage will be an interesting battle of wills.
Outside of Congress, the various proponents and opponents of the two bills have shown differing approaches in how they are trying to sell their arguments. BIO has said that it has safety concerns over H.R. 1427, whilst applauds the alternative bill, H.R. 1548, for being safer. However, it seems likely that BIO‟s more immediate concern is over the length of data protection, which is a legitimate concern for the industry, but not necessarily one that will fly with the general public. BIO also expresses concern that H.R. 1427 would jeopardise biotech jobs, noting that the industry supports 7.5 million jobs in America, with these jobs generally being highly paid, and therefore good contributors to the economy. Conversely, the GPhA also uses the economy angle in its support of H.R. 1427, arguing that the bill would help the economy by strengthening healthcare whilst reducing costs to the public. The GPhA adds that the bill is supported by consumer, business and labour organisations. Both sides recognise that a regulatory pathway for biosimilars is inevitable. However, what shape that legislation will ultimately take is less clear, and will seemingly depend on political skills and an ability to convince public opinion.
Ian Platts - Editor, World Generic Markets
Thursday, March 26, 2009
Despite speculation, Actavis branches out
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
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
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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