Generics

MSF challenges hepatitis C patent in China

Generics/General | Posted 20/07/2018

Médecins Sans Frontières (MSF, Doctors Without Borders) announced on 19 June 2018 that it was challenging the ‘unmerited’ patent in China for hepatitis C medicine velpatasvir from Gilead Sciences (Gilead). The health advocacy group said that ‘affordable generic versions from China could save millions of people’s lives’.

Generic cancer pain relief launched in Japan

Generics/News | Posted 20/07/2018

Japan-based Daiichi Sankyo announced on 15 June 2018 that it had launched a generic version of cancer pain relief Fentos Tape (fentanyl citrate tape).

Generic sofosbuvir and daclatasvir bioequivalent to originators

Generics/Research | Posted 13/07/2018

With the aim of eliminating hepatitis C (HCV) by 2030, some originator pharmaceutical companies have granted voluntary licences to generics companies to mass produce the direct-acting antivirals (DAAs) sofosbuvir and daclatasvir at low cost. In order to achieve this, generics makers need to demonstrate bioequivalent pharmacokinetics for their DAAs, compared to the originators. Therefore, researchers carried out a study to determine whether generics of sofosbuvir and daclatasvir had bioequivalent pharmacokinetics to the originators [1].

FDA approves first Suboxone generics for opioid dependence

Generics/News | Posted 13/07/2018

The US Food and Drug Administration (FDA) announced on 14 June 2018 that it had approved the first generics of Suboxone (buprenorphine/naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. The generics have been developed by Indian generics maker Dr Reddy’s Laboratories (Dr Reddy’s) and US-based drugmaker Mylan.

UK investigates price increases for generics

Generics/General | Posted 06/07/2018

In light of recent increases in the price of generics, the UK’s National Audit Office (NAO) has carried out an investigation into the causes of the increases.

Generic clopidogrel non-inferior to Plavix in acute coronary syndrome

Generics/Research | Posted 29/06/2018

A team of Canadian researchers have concluded that generic clopidogrel is non-inferior to the originator drug, Plavix (clopidogrel), in the treatment of patients with acute coronary syndrome [1]

FDA publishes list of companies that block generics

Generics/General | Posted 22/06/2018

The US Food and Drug Administration (FDA) announced on 17 May 2018 that it had published a list of companies that block generics.

US approval for prostate cancer formulation and impotence generics

Generics/News | Posted 22/06/2018

The US Food and Drug Administration (FDA) has approved generics of tadalafil, used to treat male impotence, and a new abiraterone formulation, a treatment for prostate cancer.

Doctors’ perceptions of generics in Guadeloupe and Martinique

Generics/Research | Posted 15/06/2018

Doctors in Guadeloupe and Martinique are not hostile towards generics but still mostly prescribe brand-name drugs due to patient preferences, according to a study analysing the perceptions of doctors towards generics in the French speaking territories [1].

Aurobindo and Lannett expand their generics portfolios

Generics/News | Posted 15/06/2018

Both Indian generics maker Aurobindo Pharma (Aurobindo) and US generics company Lannett have announced efforts to increase their generics portfolios.

Generics market failures and non-profit manufacturing

Generics/Research | Posted 08/06/2018

Competition usually keeps the price of generics well below that of brand-name drugs. However, when there is little or no competition, generics makers can substantially increase prices, which may lead to drug shortages. One way to address such market failures could be to introduce a non-profit generics maker to the market, according to researchers from Intermountain Healthcare, the Johns Hopkins Carey Business School and the Johns Hopkins Bloomberg School of Public Health [1].

FDA to boost generics and change drug rebates to lower prices

Generics/General | Posted 08/06/2018

In two recent speeches US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has outlined plans to fight back against high drug prices. Two of the ways the agency plans to do this include increasing generics and targeting drug rebates

Antitrust activities in the pharmaceutical industry

Generics/Research | Posted 01/06/2018

High prices of prescription drugs have been highlighted as reducing access to essential drugs and have recently gained notoriety and political attention. Authors from Harvard Medical School and the law schools of the Northeastern and Rutgers Universities explain the role of antitrust law in restoring competition and restraining price increases [1].

China to exempt cancer drugs from import taxes

Generics/General | Posted 01/06/2018

Under a new policy that took effect on 1 May 2018, China will exempt as many as 28 medicines, including all cancer drugs, made overseas from import duties.

Encouraging generics could cause high prices

Generics/Research | Posted 25/05/2018

A provision introduced in October 2017 awards eligible drugmakers 180 days of exclusivity to market a generic version of one of a list of 267 medicines for which no generic version currently exists. The provision was introduced to encourage generics of off-patent drugs without generics, however, some believe it could lead to high prices [1].

Price of leukaemia drug in Japan halved

Generics/News | Posted 25/05/2018

Japanese drugmaker Ohara Pharmaceutical has reduced the price of its leukaemia generic imatinib to about half the price of the generics sold by its competitors to encourage leukaemia patients to use more affordable medication.

Hikma launches HIV generic ritonavir in the US

Generics/News | Posted 18/05/2018

Jordan-based drugmaker Hikma Pharmaceuticals (Hikma) announced on 20 March 2018 that its wholly owned US subsidiary West-Ward Pharmaceuticals Corp had launched generic ritonavir tablets (100 mg) in the US.

EMA collaboration on oversight of API makers

Generics/General | Posted 11/05/2018

The European Medicines Agency (EMA) announced on 12 April 2018 that it had published the International API inspection programme report for 2011−2016.

Alvogen receives European approval for generic lenalidomide

Generics/News | Posted 11/05/2018

US generics company Alvogen announced on 24 April 2018 that it had successfully concluded multiple registration procedures for its lenalidomide generic capsules.

Trends in use of Lipitor after introduction of generic atorvastatin

Generics/Research | Posted 04/05/2018

Big savings can be made after the introduction of generics, especially when it comes to high volume categories, such as statins. Pfizer’s Lipitor (atorvastatin) was the best-selling drug of all time until it lost its patent protection at the end of June 2011 [1] and a generic version became available in the US in November 2011 [2]. However, the impact of the introduction of generics on use of Lipitor is not known. Therefore, researchers from Duke and Yale Universities analysed trends in use and expenditures associated with Lipitor after generic atorvastatin became available [3].

Teva launches ulcerative colitis generic in the US

Generics/News | Posted 27/04/2018

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 26 March 2018 that it had launched generic mesalamine delayed-release tablets (1.2 g) in the US.

Switchback rates between generic and brand-name drugs

Generics/Research | Posted 20/04/2018

A study carried out by researchers from Harvard Medical School found a lower rate of switchback when patients were switched to an authorized generic from the brand-name product rather than when they were switched to another generic drug product [1].

Generics companies defend against illegal ‘pay-for-delay’ charges

Generics/General | Posted 20/04/2018

In March 2018, pharmaceutical companies in the US and Europe have had to defend themselves against antitrust charges. Illegal ‘pay-for-delay’ deals enable companies to profit by delaying the release of generic drug products [1]. In recent months, generics manufacturers, Impax Laboratories Inc in the US and Teva Pharmaceutical Industries (Teva) in Europe, have both been accused of entering into such deals with originator companies. In addition, US companies, Endo, Watson, Teikoku are to pay over US$270 million to settle pay-for-delay lawsuits over Endo’s Lidoderm (lidocaine) pain patch.

Australia’s Mayne Pharma launches generic antibiotic in US

Generics/News | Posted 13/04/2018

Australia-based Mayne Pharma announced on 15 March 2018 that it had launched a generic version of doxycycline monohydrate immediate release (IR) capsules (50, 75 and 100 mg) in the US.

Portugal increases use of generics for treatment of cardiovascular diseases

Generics/Research | Posted 06/04/2018

In Portugal, the use of medicines for cardiovascular system increased nearly two-fold between 2000 and 2010. As such, over a quarter of the overall expenditure on medicines during these years went towards the treatment of cardiovascular issues [1]. However, it is possible that there may be room for cost saving on these medicines through increased uptake of generic and essential medicines. A recent study by Gama et al. has outlined the trends in outpatient cardiovascular medicine use in Portugal between 2004 and 2012, with focus on the uptake of generic and essential medicines [2].

NGO urges HIV drug patent application to be denied in Argentina

Generics/General | Posted 06/04/2018

In March 2018, Argentine NGO, the Fundación Grupo Efecto Positivo (FGEP), requested that the country’s National Institute of Industrial Property (INPI) deny Gilead Sciences Inc’s patent request for an antiretroviral drug.

Pharmaceuticals and products liability litigation

Generics/Research | Posted 30/03/2018

In 2016, healthcare spending represented 17.9% of the economy of the US, a slight increase from 2015. By 2016, the average consumer in the US expended US$1,100 per capita on prescription drugs. Authors Katie McCarthy and Richard Hunter discuss the interconnections between the different types of product liability claims related to marketing and manufacturing of drugs in the pharmaceutical industry, rising drug costs, the increasing availability of generics in the marketplace. They also discuss several major cases and the outcomes of those cases as they relate to the social responsibility of drug manufacturers [1].

GSK fined GBP 37.6 million in pay-for-delay appeal

Generics/News | Posted 30/03/2018

GlaxoSmithKline (GSK) has lost its appeal over a pay-for-delay case dating back to the early 2000s and involving its now off-patent antidepressant Seroxat/Paxil (paroxetine).

Portugal saves money with increased use of cardiovascular generics

Generics/Research | Posted 23/03/2018

Cardiovascular diseases are the primary cause of mortality worldwide [1-3], accounting for over 30% of all deaths. However, in the last few decades, the number of deaths attributed to cardiovascular diseases in higher-income countries has been on the decline. This is thought to be largely due to improved and increased healthcare interventions, according to Gama et al. [4].

Barriers to HIV generics in the US

Generics/Research | Posted 16/03/2018

Combination antiretroviral therapy (ART) has dramatically improved survival rates among people with HIV and is a mainstay of HIV prevention. Generic ART medications offer the potential for treating and preventing HIV at a lower cost [1].

Lupin launches generic memantine XR capsules in the US

Generics/News | Posted 16/03/2018

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 21 February 2018 that it had launched a generic version of Allergan’s Alzheimer’s disease treatment Namenda XR (memantine XR).

Bioequivalence of brand-name and two generic tacrolimus in transplant patients

Generics/Research | Posted 09/03/2018

Although the US Food and Drug Administration’s (FDA) generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated scepticism of the generics approval process. Three areas of concern are that the pharmacokinetic properties of generic and brand-name products in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and brand-name products may not ensure bioequivalence between generics and high-risk patients may have specific bioequivalence concerns. While this study tests tacrolimus, the novel trial design and results may globally impact regulatory considerations and strategies, not only for the approval of immunosuppressants but also for other narrow therapeutic index/ critical dose drugs.

US government tries to address the increasing cost of drugs

Generics/General | Posted 02/03/2018

A report released by the Council of Economic Advisers (CEA), an executive office of the President of the US, in February 2018 outlines a number of policy changes aimed at lowering drug prices, but some experts are sceptical that the actions will accomplish that goal.

Price of Teva’s new rare disease generic shocks patients

Generics/News | Posted 02/03/2018

On 9 February 2018, Israeli generics giant Teva Pharmaceutical Industries (Teva) announced the launch of its generic version of Syprine (trientine hydrochloride) capsules, 250 mg, in the US. However, what the company termed a ‘lower-cost generic alternative’ has turned out to be almost as expensive as the originator product.

Adverse outcomes for elderly using generic versus brand-name ARBs

Generics/Research | Posted 02/03/2018

Generics are commercialized once active ingredient’s patent of a brand-name drug expires. Brand-name to generics substitutions are encouraged and favoured due to the considerable savings for both patients and payers. Comparative bioavailability studies ensure pharmacokinetic equivalence between a given brand-name drug and corresponding generics, with similar requirements worldwide. However, no clinical equivalence studies are required before generics commercialization. After commercialization, few studies have assessed outcomes between brand-name and generic drug users in cardiology, especially at a population level.

Canada’s generics industry to cut prices by up to 40%

Generics/General | Posted 23/02/2018

The pan-Canadian Pharmaceutical Alliance (pCPA) announced on 29January 2018 that together with participating federal, provincial and territorial public drug plans, and the Canadian Generic Pharmaceutical Association (CGPA), they are launching a new five-year generics initiative. As a part of this, Canada’s generic drugs industry has agreed to reduce prices of generics in exchange for the removal of open tenders for participating drug plans.