Generics
FDA approves first EpiPen generic amid shortages
The US Food and Drug Administration (FDA) announced on 16 August 2018 that it had approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and paediatric patients.
Factors influencing the use of trade and generic names
Using trade names for drugs in clinical practice has been shown to increase the use of brand-name drugs. Despite efforts by academic medical centres to teach generic drug names and discourage the use of trade names to reduce bias and contain costs, usage of trade names persists. In order to determine what factors might influence healthcare professionals to prescribe by brand-name or generic name, researchers from Stanford University School of Medicine carried out an analysis of medication pages [1].
Novartis divests dermatology and generic oral solids portfolios and part ways with Alcon
Swiss drugmaker Novartis is to divest the Sandoz US dermatology business and generic US oral solids portfolio to Aurobindo and will also part ways with eye care specialist Alcon.
Hospital use of generic drugs increases adoption by community pharmacies
A recent Japanese study reveals that hospital adoption of generic drugs can also promote their use by community pharmacies. The researchers found that hospital adoption of generic drugs increased community pharmacy dispensation by almost 10% in only a year, reducing overall medical costs [1].
Novartis accused of pay-for-delay, while Amgen sues over generic thyroid drug
Novartis is facing a lawsuit for attempts to prevent generic versions of its hypertension treatment Exforge, and Amgen announce it will be suing Accord Healthcare for patent infringement on its thyroid drug Sensipar.
Australia approves first capsule-form Viagra generic
Singapore-based iX Biopharma announced on 6 August 2018 that it had received approval from Australia’s Therapeutic Goods Administration (TGA) for its sildenafil drug, which is delivered in an oral capsule for treating erectile dysfunction.
FDA significantly increases generic user fees in 2019
The US Food and Drug Administration (FDA) has increased the amount that generics manufacturers will have to pay for large-size operation generic drug applicants by more than US$270,000 for fiscal year (FY) 2019 compared to 2018.
Generic diabetes and cancer drugs pose challenge to Bristol-Myers Squibb and Eli Lilly
Generics manufacturers in Bangladesh and Germany have recently announced the launch of generic versions of Bristol-Myers Squibb’s diabetes treatment Glucophage and Eli Lilly’s lung cancer drug Pemetrexed.
Ulcerative colitis and diabetes generics launched in US
Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 9 July 2018 that it had launched generic budesonide extended-release tablets (9 mg) in the US. Then on 25 July 2018, Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical manufacturers, announced that it had launched generic metformin extended-release tablets (500 and 1,000 mg) in the US.
Generics applications under review by EMA – June 2018
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
Product recalls increase with increasing generics competition
Generics price competition may lead to relaxed manufacturing standards and ultimately lower quality products, according to a study carried out by researchers from three US universities.
Patient sociodemographics and use of generics
Researchers from the US have found that poorer patients are more likely to use generics [1].
MSF challenges hepatitis C patent in China
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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%
The pan-Canadian Pharmaceutical Alliance (pCPA) announced on 29 January 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.
Persistence with generic imatinib in CML patients
A study carried out by researchers from Canada investigated the clinically comparability of brand-name and generic imatinib in patients treated for chronic myeloid leukaemia (CML) [1].
Europe calls for more drugs repurposing
The European Commission (EC) published a paper for the 8th Meeting of the STAMP Expert Group on 8 December 2017 regarding case studies on repurpose medicines which outlined some of the issues that are preventing development of generics for use in new indications [1]. This paper came in response to the meeting discussions of the EC’s Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) that convened on 27 June 2017 and has since started work on developing ways to encourage the repurposing of generics.
Efficacy and safety of generic imatinib after switching
A study carried out by researchers from the US investigated switching from originator to generic imatinib in patients treated for chronic myeloid leukaemia [1].
Approval rating and opinion on generic drugs in Italy: a cross-sectional study in the Liguria region
Italy has the lowest generics market share by volume in Europe (less than 20%), coming just below Portugal and Spain. While in Northern European countries the introduction of generics took place between the 1970s and 1980s, in Italy the concept of generics was only clarified in 1996 (law n. 425) and physicians were only required to inform patients from 2012 [1].
Interchangeability of gabapentin generics
Researchers from The Netherlands and the US developed a model that could describe pharmacokinetic data for generic gabapentin in order to identify potential subpopulations of individual patients with increased risk for altered pharmacokinetics [1].
FDA denies Novo Nordisk petition to block generic liraglutide
On 5 January 2018, the US Food and Drug Administration (FDA) denied Novo Nordisk’s October 2017 citizen petition [1] that sought to block generic versions of its insulin Victoza (liraglutide) and two other liraglutide containing products. In 2016, Victoza (liraglutide) brought the company US$3.2 billion in sales.
Hospitals to start own generics company
In an effort to combat regular shortages and the increasing prices of drugs, four of the US’s largest hospital systems have made plans to create a non-profit generics company.
Treatment of chronic myeloid leukaemia patients with generic imatinib in Algeria
In a developing country like Algeria expensive therapies are not available. Alternative approaches are needed. In Algeria Imatib (imatinib: CIPLA-India) was introduced in 2006; however, no study has been published yet in the North Africa region regarding response and outcome of this generic drug in chronic myeloid leukaemia (CML) patients. Therefore, researchers from the Service d’Hématologie in Algeria and France carried out a multicentre study in newly diagnosed adult CML patients in the western region of Algeria. The aim of the study was to assess the effectiveness and safety of Imatib as a frontline therapy for patients with CML [1].
France fines J&J 25 million Euro for blocking generics
A fine of Euros 25 million was imposed on Janssen-Cilag and its parent company Johnson & Johnson (J&J) by the French Competition Authority on 20 December 2017. This occurred in response to a ruling that the company deliberately slowed market access to generic copies of its painkiller Durogesic (fentanyl) and sought to restrict the development of competing products.
Mylan appeals to FDA: no approval for generic Advair Diskus based on multi-batch PK BE studies
On 5 December 2017, Mylan filed a citizen petition asking the US Food and Drug Administration (FDA) not to approve any abbreviated new drug applications (ANDAs) for generic versions of Advair Diskus that rely on data from multiple-batch studies to demonstrate pharmacokinetic (PK) bioequivalence (BE). The agency’s guidance on evaluating generic bioequivalence for this Glaxo Smith Kline asthma drug, specifies a single-batch trial design and Mylan is requesting that this is adhered to.
Generics applications under review by EMA – January 2018
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
The Greek problem of generics pricing
Over the past few decades spending on prescription pharmaceuticals has increased faster than total health spending and gross domestic product in most OECD (Organisation for Economic Co-operation and Development) countries [1, 2].
Jan Aushadhi and affordability and accessibility of medicines in India
The pharmaceutical industry in India ranks third in the world in terms of volume and 14th in terms of value. According to the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, the total turnover of India’s pharmaceutical industry between 2008 and September 2009 was US$21.04 billion. Hyderabad, Mumbai, Bangalore, Visakhapatnam and Ahmedabad are the major pharmaceutical hubs of India. The domestic market was worth US$13.8 billion in 2013.
Mylan/Aspen launch generic busulfan injection
US generics giant Mylan Pharmaceuticals (Mylan) and its partner, generics manufacturer Aspen Pharmacare Holdings (Aspen), announced on 4 December 2017 that it had launched generic Myleran (busulfan) single-dose vial in the US, after receiving final approval from the US Food and Drug Administration (FDA).
Drugmakers waking up to potential value of branded generics
Pharma companies are making a move into what may become a lucrative sector – branded generics. The concept is simple – take a generic drug, repackage it and add marketing and hey presto you have a branded generic.
Generic metformin bioequivalent in healthy volunteers in Nigeria
Researchers from Nigeria’s Obafemi Awolowo University have found generic metformin sourced in the country to be ‘not inferior’ to originator metformin [1].
REMS issues come under FDA spotlight
US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has once again chastised brand-name drug companies that deliberately delay federal procedures and use regulations to delay the entry of generics competitors.
Perceptions and attitudes towards generics in South Korea
A survey of the perception and attitude of South Korean physicians towards generics has shown that not much has changed despite the introduction of a new pharmaceutical policy in 2012 [1].
FDA tentatively approves pemetrexed generic
Eagle Pharmaceuticals (Eagle) announced on 27 October 2017 that it had been granted tentative approval from the US Food and Drug Administration (FDA) for its generic version of Eli Lilly’s lung cancer blockbuster Alimta (pemetrexed).
Kenya needs to increase use of generics to combat rising costs
Kenyan medical insurance management firms are advising that they will only pay for generics and not brand-name prescriptions.
Mergers could be causing price increases for generics
How mergers and acquisitions in the generics sector can be a factor in drug shortages and increasing prices was a question addressed by researchers from Carleton and McGill Universities in Canada [1].
EMA approval for tacrolimus generic
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 12 October 2017 that it had recommended granting marketing authorization for the tacrolimus generic tacforius.
New use for old generic could treat rare cardiovascular condition
Researchers from Canada and the UK may have found a new use for an old generic drug: treatment of the rare cardiovascular condition, pulmonary arterial hypertension (PAH).
Texan judge invalidates Restasis patents
On 16 October 2017, a federal judge in Texas invalidated four key patents for Allergen’s dry eye drug Restasis (cyclosporine ophthalmic emulsion).
Perceptions of generic drugs in Latin America: a Guatemalan case study
A recent assessment of generic drug use in Guatemala [1] revealed a widespread lack of trust in generics, due to a combination of poor quality, powerful advertising campaigns and limited state regulation.
Lupin launches generic pain-relief med in US
India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 10 October 2017 that it had launched a generic version of Allergan’s Norco (hydrocodone/acetaminophen) pain medication.
FDA trying to reduce hurdles for complex generics
Although US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb admits that ‘FDA doesn’t control drug pricing’, he points to the fact that FDA ‘policies do affect competition in the market’. With this in mind he announced on 2 October 2017 ‘a major new set of policies’ aimed at making it easier to bring generic competition to complex drugs.
Challenges in the rediscovery of old generics
Finding new treatment options by repurposing generics is a cost-effective and time-efficient way of finding a new purpose for old drugs. However, when it comes to the rediscovery of old generics there are multiple obstacles standing in the way [1].
FDA approves lidocaine ointment generic from Vitruvias Therapeutics
US-based generics maker Vitruvias Therapeutics (Vitruvias) announced on 29 September 2017 that it had received approval of a new drug application from the US Food and Drug Administration (FDA) for a new drug.
Repurposing thioguanine
Repurposing and re-registering old generics is a cost-effective and time-efficient way of finding new purposes for existing drugs. One such ‘old generic’ that has been repurposed and re-registered is thioguanine [1].
US tribal patent deal could prevent generics
A deal made between Allergan and a native American tribe could potentially protect the company from challenges on its dry eye drug Restasis (cyclosporine ophthalmic emulsion) and prevent competition from generics in the US.
Repurposing and re-registering old generics
Finding new indications for existing drugs is better known as drug rediscovery, drug repurposing or drug repositioning. It is cost-effective and time-efficient way of finding a new purpose for old drugs. However, when it comes to the rediscovery of old generics, the lack of a formal regulatory pathway for such drugs and a lack of economic interest by pharmaceutical companies, makes it a challenging pursuit [1].
