Generics
FDA approves generic osteoporosis drug
FDA announced on 4 March 2014 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Eli Lilly’s osteoporosis drug Evista (raloxifene).
Use of generic cardiovascular drugs in China
China has not yet recognized the importance of increasing generics use as a method to reduce drug prices. An analysis of drug prices in hospitals in the Chongqing province in China has shown that there are potentially major savings to be made by increasing the volume of generics used in China [1].
Teva and Ranbaxy settle unlawful competition investigation
New York Attorney General Eric Schneiderman announced on 19 February 2014 that he had reached a settlement with generics makers Ranbaxy Pharmaceuticals (Ranbaxy) and Teva Pharmaceuticals (Teva) for entering into an anti-competitive arrangement.
Compliance and persistence same for generic and brand-name alendronate
A retrospective analysis of data in Italy has shown that patients taking generic and brand-name alendronate showed the same rates of persistence and compliance [1].
FDA starts widespread testing of generics
The US Food and Drug Administration (FDA) has allocated US$20 million for testing generics and has already been assessing generics since September 2013, despite no announcement having been made.
Confusion exists in Brazil over generics
Brazilians are confused about generics and are unable to distinguish between a generic drug and a brand-name drug [1].
Gilead to license hepatitis C drug to Indian generics firms
Gilead Sciences (Gilead) has announced plans to license its breakthrough hepatitis C drug Sovaldi (sofosbuvir) to at least three Indian generics manufacturers. The announcement made in February 2014, comes three months after the company faced a ‘patent opposition’ filed at India’s Patent Office, which aimed to block them from gaining a patent for Sovaldi in India.
Sandoz gains Belgian approval for generic inhalation device
In an example of the innovative nature of generics manufacturers, Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 12 February 2014 that it had received marketing authorization in Belgium for AirFluSal Forspiro, an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).
Impact of coupons on adherence to statins
Once patents expire, in an effort to maintain market share, originator manufacturers often initiate promotional activities such as drug samples and co-pay discount coupons that reduce patients out-of-pocket costs associated with the purchase of brand-name drugs.
Effects of income, competition and procurement on drug prices in emerging markets
Drugs are least affordable relative to income in low-income countries, according to an analysis of income, competition and procurement on drug prices in emerging markets [1].
Forest Labs files lawsuit to stop generic memantine
Forest Laboratories and Forest Laboratories Holdings (Forest) announced on 31 January 2014 that the company has filed a lawsuit in the US against several generics makers for their generic versions of Forest’s blockbuster Alzheimer’s disease treatment Namenda XR (memantine).
Access to medicines in Shaanxi province China
Although generics in the Shaanxi province of China are significantly cheaper than their brand-name equivalents there is still room for improvement, according to a study of the prices and availability of selected medicines in the province [1].
Generics game changer for Ireland
A new pharmacy in Dublin, Ireland, is offering customers savings of up to 80% on the price of drugs by focussing on generics. The news comes in light of legislation passed by both houses of Ireland’s parliament in May 2013, which encourages wider use of generics and generics substitution [1].
Switching to generic cyclosporine A after heart transplant safe
Cyclosporine A is an immunosuppressant drug widely used in organ transplantation to prevent rejection. A study of switching between originator and generic drugs showed that the generic was well tolerated and that there were no differences between the originator and generic drugs [1].
FDA issues Ranbaxy with Form 483 for violations at Toansa plant
Ranbaxy Pharmaceuticals (Ranbaxy) is coming under scrutiny from US Food and Drug Administration (FDA) once again. One of the company’s key Indian facilities at Toansa, Punjab, has been issued a Form 483 by FDA.
ANI Pharmaceuticals acquires 31 generics from Teva
US-based brand-name and generics manufacturer ANI Pharmaceuticals (ANI) announced on 26 December 2013 that it had acquired 31 previously marketed generic drugs from Teva Pharmaceutical Industries (Teva).
Sandoz gains Danish approval for innovative asthma inhaler
Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 18 December 2013 that it had received Danish marketing authorization for AirFluSal Forspiro, a novel inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).
Generics applications under review by EMA – 2013 Q4
Last update: 20 January 2014
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].
First generics of Cymbalta approved by FDA
The US Food and Drug Administration (FDA) announced on 11 December 2013 that it had approved the first generic versions of duloxetine delayed-release capsules, a prescription medicine used to treat depression and other conditions.
Recent reforms and initiatives in Scotland to encourage the prescribing of generic drugs and the implications
Scotland has introduced a number of reforms and initiatives in recent years to enhance the prescribing of low cost generics, thereby saving money to help fund increased volumes and new premium priced drugs [1, 2]. However, there have been situations where no specific initiatives have been introduced [3, 4]. Consequently, analysis of the various initiatives in Scotland could provide examples to other countries seeking additional measures to further enhance their prescribing efficiency.
Sandoz makes deal with Shire for authorized Adderall XR generic
Shire announced on 2 December 2013 that its subsidiary Shire US had entered into an agreement to supply an authorized generic version of its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts) to Sandoz.
Understanding pharmaceutical expenditure
In the previous three articles by Vogler and co-authors price and volume components of pharmaceutical expenditure were discussed. In the final article of the series, some of the methodological challenges that can be faced in interpreting and analysing expenditure data are addressed and the challenges faced by the authors’ own survey of pharmaceutical expenditure data across European Union Member States are discussed [1].
Rising generics use triggers increased worldwide regulation
The increasing use of lower cost generics is prompting regulators across the globe to introduce stricter regulations focusing on the quality of these products.
Hikma makes deal to enhance delivery of generic injectables
Hikma Pharmaceuticals (Hikma) announced on 20 November 2013 that it had signed a long-term commercial supply contract with Unilife Corporation (Unilife) for the use of Unifill pre-filled syringes with a range of generic injectable drugs.
Volume components of pharmaceutical expenditure
In the third of a series of four articles on pharmaceutical expenditure, Vogler and co-authors explain the different methodological approaches to measuring pharmaceutical utilization and outline some of the volume-control policies in place across Europe [1].
FDA approves first rabeprazole generics for treatment of GERD
On 8 November 2013, the US Food and Drug Administration (FDA) announced that the agency had approved the first generics of Aciphex (rabeprazole) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
FDA awards grant to study generic transplant drug tacrolimus
The US Food and Drug Administration (FDA) has awarded a federal grant worth US$2.3 million to researchers at the University of Cincinnati, Ohio, USA, in order to continue studies into tacrolimus, a drug commonly used to stop rejection in transplant patients.
First generic 30 mg Focalin XR capsules approved
On 18 November 2013, Mylan Pharmaceuticals announced the launch of generic dexmethylphenidate hydrochloride extended-release (ER) capsules, 30 mg.
Price components of pharmaceutical expenditure
In the second of a series of four articles on pharmaceutical expenditure, Vogler and co-authors take a top down approach to the concept of pharmaceutical expenditure and its use as an indicator in healthcare accounting. Here, they look at the differences in outpatient and inpatient price types [1].
Ranbaxy sues Actavis over generic acne drug
Indian generics giant Ranbaxy Laboratories (Ranbaxy) is suing US generic drugmaker Actavis to try to stop the latter marketing a generic version of Ranbaxy’s acne drug Absorica (isotretinoin).
Pharmaceutical expenditure as a health-expenditure indicator
Pharmaceutical expenditure is a major indicator in health-expenditure accounting, and is particularly useful to policymakers and researchers in making regional, country and international comparisons, forecasting, and assessing the effect of pharmaceutical policies [1].
South African HCPs told to ‘get their facts straight’ on generics
The South African National Association of Pharmaceutical Manufacturers (NAPM) urged healthcare professionals (HCPs) to ‘get their facts straight’ with respect to generics at a special workshop held at the Johannesburg Country Club on 17 October 2013.
Good news for Ranbaxy plant in US
Ranbaxy Laboratory’s (Ranbaxy) US-based plant, Ohm Laboratories (Ohm), has successfully passed an FDA inspection, according to an announcement on the generic drugmaker’s website.
Canada-EU trade deal will extend patents for two years
On 18 October 2013, Canada and the European Union (EU) reached agreement on a trade deal, which will free the movement of goods, services, investment and labour between the two regions, but has been criticized by generics makers for delaying access to medicines.
FDA approves generic tobramycin inhalation solution
Teva Pharmaceutical Industries (Teva) announced on 14 October 2013 that the US Food and Drug Administration (FDA) had granted approval for its abbreviated new drug application (ANDA) for tobramycin inhalation solution.
Making generics of Advair could be difficult
GlaxoSmithKline’s (GSK) fears of generics competition for its chronic obstructive pulmonary disorder treatment Advair (fluticasone/salmeterol) may be unfounded according to generics manufacturer Teva Pharmaceutical Industries (Teva).
US court paves way for Nexium competition
AstraZeneca announced on 2 October 2013 that the US Court of Appeals for the Federal Circuit had lifted a temporary injunction against the US launch of Hanmi Pharmaceutical’s (Hanmi’s) esomeprazole strontium product.
Forest initiates lawsuits over generic Savella
Forest Laboratories and Forest Laboratories Holdings (Forest) announced that Forest and Royalty Pharma Collection Trust (Royalty Pharma) are suing several generics manufacturers regarding generics of Savella (milnacipran).
Australians pay too much for generics
According to the Consumers Health Forum of Australia (CHF), a body which represents healthcare consumers, Australians are paying way too much for their generic drugs.
FDA approves generic version of cancer drug
FDA announced on 16 September 2013 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Roche’s cancer drug Xeloda (capecitabine).
Transplant coordinators’ perception of generic immunosuppressants
Transplant coordinators associate the availability of multiple generic immunosuppression therapies with increased patient confusion, according to a study by Parker and co-authors [1].
Generics applications under review by EMA – 2013 Q3
Last update: 4 October 2013
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 27 EU Member States and in Norway, Iceland and Liechtenstein. 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].
Generics of fish oil cholesterol treatment get go ahead
A US appeals court ruled on 12 September 2013 that generics companies can develop their own versions of Lovaza, a fish oil-derived drug used to treat high cholesterol, which is currently marketed in the US by GlaxoSmithKline (GSK).
Australian generics association releases new code of practice
Australia’s Generic Medicines Industry Association (GMiA) announced on 26 September 2013 the release of the draft third edition of the GMiA Code of Practice, which incorporates a number of new amendments.
Advair could face competition from generics as early as 2016
GlaxoSmithKline’s (GSK) asthma and chronic obstructive pulmonary disorder treatment Advair (fluticasone/salmeterol) could face competition from generics sooner than expected, after FDA issued draft guidance on generics of the drug.
Ranbaxy receives another import ban from FDA
Ranbaxy Laboratories (Ranbaxy) has come into FDA’s firing line again. This time generics manufacturer is under scrutiny for problems at its Mohali manufacturing site.
Use of generic anti-asthmatic drugs in Morocco
Asthma is a serious public health problem in Morocco. However, due to low income and lack of healthcare coverage in the country many of Morocco’s citizens do not have access to anti-asthmatic drugs.
Southeast Asian generics market to reach US$3.9 billion by 2016
Southeast Asia, with its fast-growing, young population and uninsured majority represent a great opportunity for generics in the pharmaceutical industry, according to Rhett Hemedes, Head of OTC Marketing, Great Eastern Drug Co.
Avanir and Wockhardt settle Nuedexta patent dispute
US-based Avanir Pharmaceuticals (Avanir) announced on 6 September 2013 that it had entered into a settlement agreement with Wockhardt USA, the US subsidiary of India-based generics maker Wockhardt, regarding Nuedexta (dextromethorphan hydrobromide/quinidine sulfate).
Actavis confirms Rayos patent challenge and Warner Chilcott acquisition
Actavis has filed for US approval for a generic version of the anti-inflammatory or immunosuppressive agent Rayos (prednisone). The company also confirmed its proposed acquisition of Warner Chilcott.
Ranbaxy to expand Russian portfolio
Generics manufacturer Ranbaxy Laboratories (Ranbaxy) has been in the Russian pharmaceuticals market for 20 years and is now considering expanding its product offering in the country.
Therapeutic substitution could save Americans money
Substituting more expensive brand-name drugs with generics or therapeutic substitutes, could lead to significant savings for Medicare Part D beneficiaries, according to US researchers [1].
Mylan and Par pass FDA scrutiny on Wellbutrin generics
Mylan and Par Pharmaceutical (Par) announced on 20 and 22 August 2013, respectively, that they have passed FDA scrutiny of their generics of antidepressant Wellbutrin XL (bupropion).
Strategies used by sickness funds to increase generics prescribing in Austria
In 2010, a survey of Austrian sickness funds was undertaken to evaluate how Austrian doctors, patients and pharmacists are encouraged to enhance the rational use of medicines, and increase use of generics [1].
Allergan objects to Restasis generics being accepted without human trials
Following the publishing of draft guidance on cyclosporine by FDA, ophthalmic specialist Allergan is requesting that FDA revise its guidance on cyclosporines, arguing that generic versions of its eye drug Restasis (cyclosporine ophthalmic emulsion) should be tested in humans before approval, not just in a laboratory.
Interchangeability of gabapentin generic formulations in The Netherlands: summary of a comparative bioavailability study
Abstract
The registration of generic formulations in the EU is governed by regulatory authorities in the respective European countries. Before a generic drug can be registered, bioequivalence to the branded formulation has to be demonstrated, i.e. 90% confidence intervals of area under the curve (AUC), and Cmax should fall within the 80–125% acceptance range. Comparative studies with other generics are not required. In order to establish whether a generic medicine is interchangeable with other generic formulations under current regulations, the Dutch regulatory authority conducted a single- dose, four-way crossover comparative bioavailability study with four gabapentin formulations, i.e. the branded formulation and three generic drugs, as test medication. The results showed that all four formulations were bioequivalent to each other, and that no interchangeability issues would result from switching.
FDA increases generic drug user fees in 2014
FDA has increased the amount that generics manufacturers will have to pay to register their finished drug formulation (FDF) facilities by more than US$40,000 for 2014 compared to 2013.
Eli Lilly attempts to further delay Alimta generics
Pharma giant Eli Lilly was scheduled to be in court on 19 August 2013 to defend another of its patents on its blockbuster lung cancer drug Alimta (pemetrexed).
Pfizer’s US$2.15 billion settlement with Teva and Sun Pharma
Pfizer announced in June a US$2.15 billion settlement with Teva and Sun Pharmaceutical Industries (Sun Pharma) for patent-infringement damages resulting from unlawful launches of generic Protonix (pantoprazole) in the US.
How regional sickness funds in Austria encourage more rational prescribing
In Austria, as in other EU countries, rational use of medicines is high on the healthcare agenda. According to WHO, use of generic medicines help reduce costs incurred by public payers and is a way of supporting rational use of medicines.
Implications of the changes in venlafaxine utilization in Sweden following generics
Godman and co-authors review the changes in the utilization of venlafaxine post generics. This includes the limited influence on utilization post generics with no specific demand-side measures. This changed following prescribing restrictions for duloxetine. However, influence limited by the need to tailor treatments for patients with depression [1].
The cost of evergreening strategies
The practice of evergreening, where pharmaceutical companies make small patentable changes to existing products with soon-to-expire patents, contributed to increased healthcare costs in Switzerland, according to a study by authors from the University of Geneva and Geneva University Hospitals [1].
Perrigo receives tentative FDA approval for generic Prandin
US-based drugmaker Perrigo Company (Perrigo) announced on 19 July 2013 that it had received tentative approval from FDA for its abbreviated new drug application (ANDA) for repaglinide tablets.
Indian generics companies top ANDA approvals
Indian generics companies are beating many other countries when it comes to gaining US FDA approval for their generic drugs.
Use of brand-name drugs increasing healthcare costs in US
Patients with diabetes who are covered by the US healthcare insurance Medicare are two to three times more likely to use expensive brand-name drugs compared to patients treated within the Veterans Affairs Healthcare System [1].
Teva loses fight against generic glatiramer acetate
On 26 July 2013 the US Federal Circuit Court of Appeals invalidated several of Teva’s patents on Copaxone (glatiramer acetate), including one that protected the drug until September 2015.
Generics combo non-inferior to treatment with Enbrel
A study carried out by researchers from the US Department of Veterans Affairs and the Canadian Institutes for Health Research has found that a combination of three generic drugs is non-inferior to treatment with Amgen’s blockbuster biological Enbrel (etanercept) [1].
Generics applications under review by EMA – 2013 Q2
Last update: 6 September 2013
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 27 EU member states and in Norway, Iceland and Liechtenstein. 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].
Enhancing prescribing efficiency in the Republic of Srpska
It has been claimed that countries with smaller populations have difficulties obtaining considerable price reductions for generics. However, evidence from the Republic of Srpska, which is one of the two constitutive entities of Bosnia and Herzegovina, with a population of only 1.43 million, proves otherwise [1].
Ranbaxy faces lawsuit in India
An Indian lawyer has filed a lawsuit asking the Indian Supreme Court to investigate Ranbaxy Laboratories (Ranbaxy), its executives and Indian drug control officers, as well as to shut down two of Ranbaxy’s Indian plants.
Actavis submits ANDAs for two more generics
Actavis has filed for US approval for generic versions of a contraceptive and a sedative/anaesthetic.
Teva and Sun Pharma settle battle over generic Protonix
Pfizer announced on 12 June 2013 that the pharma giant had reached a settlement with generics manufacturers Teva Pharmaceuticals Industries (Teva) and Sun Pharmaceutical Industries (Sun Pharma) for damages resulting from their ‘at-risk’ launches of generic pantoprazole in the US.
Dr Reddy’s and Fujifilm call off joint venture for generics in Japan
Two years after signing a deal to work together on generics in Japan, Fujifilm Corporation (Fujifilm) and Dr Reddy’s Laboratories (Dr Reddy’s) have called off their agreement.
Equivalence of generic immunosuppressants
There are no compelling pharmacological arguments against the sensible use of the generic immunosuppressants ciclosporin, tacrolimus and mycophenolate mofetil in clinical practice, argue pharmacologists working in drug evaluation in The Netherlands [1].
US appeals court halts Pulmicort generics
On 25 May 2013, the US Court of Appeals for the Federal Circuit issued a temporary injunction in the US stopping generics of AstraZeneca’s asthma treatment Pulmicort Respules (budesonide inhalation suspension).
Lipitor generics saved UK NHS £350 million in first 12 months
Generics of the blockbuster cholesterol-lowering drug Lipitor (atorvastatin) saved the UK’s National Health Service (NHS) more than GBP 350 million in the first 12 months following the expiration of Pfizer’s patent exclusivity.
Ranbaxy pays US$500 million to resolve US litigation
In what has been hailed as the largest ever settlement of its kind involving a drug safety settlement with a generics manufacturer, Ranbaxy Laboratories (Ranbaxy) pleaded guilty to violations of the Food, Drug and Cosmetics Act (FDCA) and making false statements.
Sanofi fined for discouraging generic clopidogrel prescriptions
On 14 May 2013, French drugmaker sanofi-aventis was fined Euros 40.6 million by the French competition authority (L’Autorité de la concurrence) for marketing practices that discouraged sales of generic versions of its blood thinner Plavix (clopidogrel).
FDA rejects Endo petition to stop Opana ER generics
On 10 May 2013, FDA announced that it had rejected a petition by Endo Pharmaceuticals (Endo) to stop generics of its powerful painkiller, Opana ER (oxymorphone).
The biggest drug patent losses for 2013
During 2012–2018 over US$290 billion of sales are at risk from patent expirations. In fact, in 2013 alone patents will expire on drugs with yearly sales of US$29 billion. Generics are expected to grab 70% of those sales.
