Policies & Legislation

New Zealand expects big savings with generic quetiapine

The New Zealand pharmaceutical management agency, PHARMAC, expects to save NZ$24 million (US$17.1 million) over the next five years following price reductions for certain antipsychotic drugs. The agency intends to use the savings to fund other medicines.

Battle over ‘pay-for-delay’ deals continues

The US Federal Trade Commission (FTC) Chairman, Mr Jon Leibowitz, has been arguing for some months now that passing legislation to restrict pay-for-delay deals between brand name and generic drugmakers will save US consumers billions of dollars. However, a new report throws doubt on the figures used to estimate these savings.

US healthcare reform

The tide is finally changing in the US with reform of the healthcare system finally set to provide universal health care to most of the US population. This is great news for the American citizen, but what are the implications for generics and biosimilars in this changing environment?

Indian government encourages biosimilars

India has, by far, demonstrated the greatest acceptance of biosimilars. In recent years over 50 biopharmaceutical products have been approved for marketing in India, with more than half of them being biosimilars.

US bill to curb generic ‘pay-for-delay’ deals

US drugmakers reacted with anger on 2 July 2010, as the House of Representatives voted in favour of measures to severely curb ‘pay-for-delay’ deals between brand name and generic firms, which have been included, bizarrely, in the War Funding Bill.

Spanish government introduces harsh generic price cuts

There has been a sustained slowdown in the Spanish economy since 2008. This has been aggravated by the major international financial crisis, resulting in a decrease in the Spanish Gross Domestic Product (GDP) of 3.6% in 2009. The government has therefore introduced measures to decrease the budget deficit, which include reduction of expenditure by the National Health System.

Spanish government urged to increase generics volume

In response to recent stringent price-cutting measures introduced in Spain, the Director General of the European Generic Medicines Association (EGA), Mr Greg Perry, has written to the Spanish Minister for Health and Social Policy. He is concerned about the effect these “overly-harsh price cuts” may have on the economic sustainability of AESEG´s (the Spanish Generic Medicines Association) member companies.

European Commission welcomes reduction in ‘potentially problematic’ patent settlements

A European Commission (EC) report on the monitoring of patent settlements has found that the number of patent settlements in the pharmaceutical sector that are ‘potentially problematic’ under the EU’s antitrust rules fell to 10% of total patent settlements in the sector in the period July 2008 to December 2009 compared with 22% in the period covered in last year's inquiry (January 2000–June 2008).

FDA ANDAs containing paragraph IV patent certifications

In the US, under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from the FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The first company to submit an Abbreviated New Drug Application (ANDA) with the FDA has the exclusive right to market the generic drug for 180 days.

Russian drug spending set to reach US$4 billion by 2020

Russia is planning to pump RUB 120 billion (US$4 billion) into its fledgling pharmaceutical sector this decade as part of a broader push to diversify the economy away from its traditional oil and gas industry.

Danish healthcare spending cuts

In a bid to cut public spending, the Danish government is the latest to announce an austerity package aimed at creating savings of at least DKK 24 billion. The austerity package, as well as slashing unemployment benefits and cutting governmental salaries, also focuses on cost-containment within the healthcare sector.

Austerity measures introduced in Portugal affect generics

Portugal has introduced new measures, published in Portugal’s official journal, Diário da República, which aim to increase domestic access to medicines, stimulate the uptake of generics and make the reimbursement system more efficient. However, both the generic medicines and R & D-based industry have criticised the measures.

Italian austerity measures include generic price cuts

The Italian government has joined many other European countries in introducing measures to slash public spending. Italy’s government has approved a Euros 24 billion austerity package aimed at reducing the national budget deficit – which last year was 5.3% of its gross domestic product – to within the euro-zone limit of 3% by 2012. Cuts aimed at generic medicines are also included amongst these measures.

The preference policy in The Netherlands

The Netherlands is threatening its generic manufacturing industry with its preference policy, according to Mr Frank Bongers, Chairman of Bond Van De Generieke Geneesmiddelenindustrie Nederland (Bogin) – the Association of the Dutch Generic Medicines Industry, and member of the Executive Committee of the European Generic Medicines Association.

Obama refuses to put US healthcare reform on the shelf

As reported by Scrip, US President Mr Barack Obama made clear that he is continuing to push for sweeping changes in the US healthcare system that would extend coverage of tens of millions of Americans who are now uninsured, as he pointed out in his eagerly awaited US State of the Union speech to a joint session of Congress the night of 27 January 2010.

Japan wants to stimulate generics and biosimilars

As reported by Ian Haydock in Scrip News of 19 January 2010, the debate over reforms to Japan's drug reimbursement pricing system is continuing to inch ahead, with signs emerging that the changes could be a double-edged sword for the industry.

FTC Chairman and US Congress members call for US legislation to end ‘pay-for-delay’ deals

On 13 January 2010, US Federal Trade Commission (FTC) Chairman Jon Leibowitz and key members of US Congress, including Representative Chris Van Hollen, Chairman Bobby Rush, and Representative Mary Jo Kilroy, renewed their call for US legislation that would put an end to anticompetitive patent settlements, which drug manufacturers have been using to keep less-expensive medicines off the market and charge consumers billions of dollars a year in higher drug prices.

Obama wants 10 years or less of biologicals data exclusivity

According to The Associated Press (AP), US President Obama and US House Democrat Henry Waxman have teamed up to make a last-minute push to significantly pare back the 12-year period of data exclusivity lawmakers provided biologicals in the healthcare reform bill. With White House and congressional bargainers moving toward a final health bill, President Obama and Representative Henry Waxman, Chairman of the House Energy and Commerce Committee, are trying to reduce the curbs against competition to 10 years or less.

If they are successful, it would be a major blow to the industry's leading lobbyists at the Biotechnology Industry Organization (BIO) as well as the Pharmaceutical Research and Manufacturers of America (PhRMA), who have managed to hold together a large coalition of US Democrats and Republicans in favour of the long stretch of protection from generic competition.

Data exclusivity is not the same as market exclusivity

Gene Quinn distinguishes facts from fiction on biosimilars on IPWatchdog.com.

According to him, data exclusivity is not the same as market exclusivity. “During a period of data exclusivity, a competitor would be unable to piggyback on the massive investment in R & D made by an innovator to receive approval from the FDA for their ‘copy-cat’ product. Simply put, during the period of exclusivity the FDA may not rely on an innovator’s safety and efficacy data to approve a competitor’s product. Market exclusivity is an altogether different thing – it is the inability of any competitor to enter a specific market. Market exclusivity for biological products would mean that there could be, for example, just one drug to treat leukaemia, one drug to treat diabetes, one drug to treat MS. “This is not the case”, he stresses. “At any moment, hundreds of biotech companies are racing to develop the next wonder drug for any one of these diseases. That situation will not change because of data exclusivity periods. There will continue to be competition among innovative biological products regardless of a data exclusivity period enacted as part of biosimilars legislation”.

According to Mr Quinn, providing innovators with data exclusivity enables them to recoup the investments they made into developing new products and testing product safety and efficacy. “This allows them to continue to invest in new breakthrough medicines, therapies and cures for diseases such as cancer, HIV/Aids and ALS. Competitors are free at any time to conduct their own costly research and development, including clinical trials, and create their own biologicals”, he argues.

Pfizer and the US Biosimilars Pathway

Both the US House and Senate healthcare bills include language that would allow US regulators to set up a method for approving copies of biotechnology drugs. Under the proposals, biologicals would get 12 years of market exclusivity before copies could enter the market. Both US chambers must agree on final language in their overhaul measures.

US regulators should catch up with Biosimilars Pathway

A proposal by US Democratic Representative Anna Eshoo included in the US House health reform bill, would give developers of innovative biomedical drugs 12 years of data exclusivity from generic competition, significantly extending their patent rights, writes Los Angeles Times columnist Michael Hiltzik.

Operation Pangea II seizes 167,000 counterfeit pills

A five-day international anti-counterfeiting operation, called ‘Operation Pangea II’ and involving regulators, police and customs officials from 24 countries, has resulted in a series of arrests and the seizure of 167,000 potentially harmful medical products or ‘counterfeit pills’.

The role of patents in a pathway for the approval of biosimilars

The healthcare reform bill recently approved by the US House of Representatives includes a provision to establish a pathway for biosimilars, as does the healthcare reform bill currently pending in the US Senate.

EU blocks generics for Third World countries

Because of their behaviour against alleged patent infringements by Indian pharmaceutical manufacturers, according to the German Financial Times (FTD) the EU gets pressurised.

US FTC ‘hampered’ by Boehringer Ingelheim's delay tactics

The US Federal Trade Commission (FTC), which is investigating patent settlements between Boehringer Ingelheim and Barr (now part of Teva Pharmaceutical Industries) on Aggrenox (aspirin plus extended-release dipyridamole) and Mirapex (pramipexole), has asked for a court order requiring Boehringer to fully comply with a subpoena issued nine months ago for documents and data.

COSTEFF: Parallel trade, generics, biosimilars and home care can reduce European healthcare costs

We are all familiar with the pressures piling up on healthcare systems around the world. People are living longer and diseases of ageing, such as dementia, are becoming more prevalent. Some illnesses linked to lifestyle, such as diabetes, are also on the rise.

US Senate panel votes to outlaw ‘pay-for-delay’ deals

The US Senate Judiciary Committee has voted 12-7 in favour of legislation to outlaw deals agreed between branded drugmakers and generics firms to delay the entry of generic competitors to the market.

Indian firms race to sell generic oseltamivir

With the Indian government permitting ‘restricted’ sales of oseltamivir, a generic version of Roche's Tamiflu for influenza A H1N1, the domestic market is seeing a flurry of activity as Indian firms move to stock their products at retail pharmacies.

US court upholds Lilly’s Evista (raloxifene) patents through 2014, blocking Teva’s generic

A US federal judge has upheld Lilly's method-of-use patents for its osteoporosis drug Evista (raloxifene) through to March 2014, blocking an attempt by Teva Pharmaceutical Industries to sell a generic version. The product has annual US sales of around US$650 million (Euros 442 million). Teva said it plans to appeal the decision.

Generic drugmakers criticise US health plan rebates

The US government could save more money by increasing the use of cheaper generic drugs rather than hiking rebates paid by manufacturers, an industry executive said on 17 September 2009.

Roche and Amgen agree on temporary Mircera import ban

Roche has agreed not to oppose Amgen's request for a limited exclusion order that would block the import of Roche's anaemia drug Mircera into the US Amgen filed a motion recently with the US International Trade Commission (ITC) asking for a summary determination that Roche had violated a section of the Smoot-Hawley Tariff Act by importing the pegylated erythropoietin product Mircera (methoxy polyethylene glycol-epoetin beta), which Amgen claims infringes its patents.

EU assures India to take steps to resolve drug seizure cases

The EU has assured India that it will take steps to resolve the issue related to the recent cases of life-saving generic or off-patent medicines exported from India to other countries being seized at European ports, but would prefer not to do so through a legal battle at the World Trade Organization (WTO).

Biosimilars advancing along European approval path

With an EU regulatory framework in place to address the safety of biosimilars – also known as follow-on biologics (FOBs) – the opportunity represented by these products has been proven, and it is growing, as reported by Cynthia Challener in ICIS Chemical Business.

WHO has prequalification multisource (generic) guideline

On 18 June 2009, WHO published a Prequalification Update, informing that a guideline on submission of documentation for prequalification of multisource (generic) has been completed and that Finished Pharmaceutical Products (FPPs) will be approved by Stringent Regulatory Authorities (SRAs). It states that WHO recognises the scientific evaluation of multisource (generic) products by regulatory authorities, which apply similarly stringent standards for quality, safety and efficacy as those recommended by WHO.

US bill proposes Comparative-Effectiveness Research Centre

Mr Randall Stafford of the Stanford Prevention Research Center and Mr Caleb Alexander of the University of Chicago, USA have published several challenges that must be met if comparative-effectiveness research (CER) is to be useful in significantly improving the quality and affordability of US health care. In the 17 June 2009 issue of the Journal of the American Medical Association they write, “Researchers, policy makers, insurers, and other stakeholders have voiced enthusiasm about the value of CER that rigorously evaluates two or more drugs or devices. The most recent boost for these efforts has been the US congressional financial stimulus package that contains provisions for US$1.1 billion (Euros 787.4 million) to be devoted to this effort. The appeal of CER is undeniable. If there is one issue that stakeholders agree about, it is that increasing healthcare costs are ultimately unsustainable and society needs more value for its money. However, it is not clear whether CER, as it is commonly framed, has a comparative advantage when it comes to improving the US healthcare system. If CER is to succeed, future initiatives will need to generate data prior to the widespread adoption of a drug or device.”

BIO: Patent gap for biologicals ignored by Federal Trade Commission report

In the US, the outstanding issue surrounding the biosimilars debate remains the exclusivity period before competitors can come on the US market – and the US is no closer to a resolution following the 10 June 2009 report by the Federal Trade Commission (FTC), Emerging Health Care Issues: Follow-on Biologic Drug Competition.

Teva wants new rules for first generic entrants in EU

In Europe first EU generic entrants should be given a period of market exclusivity, Teva Europe President and CEO, Dr Gerard Van Odijk, claimed at the World Generic Medicines Congress Europe 2009 held in London, UK, in February. He said that once a product’s patent expired “everyone jumps on the bandwagon. What we need is an alternative way to continue the appetite to take risks in Europe.”

Regulatory approval of biosimilars in Europe

Biosimilars present a new set of challenges for regulatory authorities compared with conventional small-molecule generics, for which the demonstration of pharmacokinetic similarity to the reference product is sufficient.