Generics

FDA approves generic osteoporosis drug

Generics/News | Posted 14/03/2014

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

Generics/Research | Posted 07/03/2014

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

Generics/News | Posted 07/03/2014

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

Generics/Research | Posted 28/02/2014

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

Generics/General | Posted 28/02/2014

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

Generics/Research | Posted 21/02/2014

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

Generics/News | Posted 21/02/2014

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

Generics/News | Posted 14/02/2014

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

Generics/Research | Posted 14/02/2014

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

Generics/Research | Posted 07/02/2014

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

Generics/News | Posted 07/02/2014

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

Generics/Research | Posted 31/01/2014

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

Generics/General | Posted 31/01/2014

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

Generics/Research | Posted 24/01/2014

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

Generics/News | Posted 24/01/2014

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

Generics/News | Posted 17/01/2014

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

Generics/News | Posted 10/01/2014

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

Generics/General | Posted 10/01/2014

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

Generics/News | Posted 10/01/2014

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

Generics/Research | Posted 13/12/2013

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.