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HIV generics could significantly cut treatment costs

The US Government could save almost US$1 billion in the first year alone by using generic rather than brand-name drugs for the treatment of HIV patients, according to a study published in the Annals of Internal Medicine [1].

Overview of research on regulatory issues for generics in 2012

Period: January to August 2012 

Regulatory issues are a challenge facing generics of all kinds, and one that may limit the competitiveness and sustainability of the generics industry. However, with the cost of medicines becoming a more and more important factor for patients and the healthcare industry as a whole there is a need for both harmonization of regulatory requirements between different regions, e.g. Canada, EU and US, as well as a need for clarity in the regulatory requirements for certain generics.

Brand-name and generics labels don’t match

According to US federal law generics manufacturers have to have the same labelling as their brand-named counterparts. However, a new study has found that in practice this is often not the case.

Patent cliff winners and losers

During 2011 and 2012 a whole host of patents have expired on many blockbuster drugs. In fact it was estimated that in 2012 US$33 billion of sales would be lost due to the patent cliff [1].

US pharmacists positive about generic drugs

Pharmacists, prescribers and patients often voice concerns about the safety and efficacy of generic drugs when they are substituted for brand-name drugs. Results of a survey, reported by Ms Laurie Scudder, shows that pharmacist and prescriber opinions on generic drugs in the US are generally positive, see Figure 1.

Overview of research on ‘specific’ policies aimed at generics in 2012

Period: January to August 2012 

Countries around the world have embraced generics due to their cost-saving potential. Many governments already have policies in place to promote the use of generic medicines, and as health systems face continuous cost pressures and demands to invest in new technologies, generics can only become more important.

Safety and efficacy of generic tenofir/lamivudine/efavirenz combination

New research shows the safety and efficacy of a generics combination of tenofir, lamivudine and efavirenz in the treatment of HIV-infected patients in Thailand [1].

Black-box safety warnings and the future of generic drug liability

Generic medicines currently have no responsibility for adding warnings about adverse effects of their medicines. Despite the US Supreme Court ruling that it was ‘impossible’ to force generics manufacturers to update their labels with the latest warnings, many feel that they have an ethical responsibility to do just that [1].

Overview of research on ‘general’ policies aimed at generics in 2012

Period: January to August 2012 

Many governments around the world already have policies in place to promote the use of generic medicines, and with the increasing cost of health care and restrictions on budgets the need for low cost, quality medications can only become more important.

The ethics of generic drug liability

What responsibility should the manufacturers of generic medicines bear for warnings about adverse effects of their medicines? Indeed, what responsibility should be borne by the original manufacturers of these drugs? What happens if an adverse effect is noticed after the drug has been in use for many years? Such questions are being pondered in the US after a recent ruling in which the Supreme Court decided it was ‘impossible’ to force generics manufacturers to update their labels with the latest warnings.

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