Generics

Impact of price cuts on spending on hyperlipidaemic drugs in South Korea

Generics/Research | Posted 06/06/2014

Rapidly increasing pharmaceutical expenditures have become a constant challenge to the sustainability of healthcare systems across countries including Korea.

Sun Pharma’s Gujarat site under FDA import alert

Generics/News | Posted 06/06/2014

Sun Pharmaceutical Industries’ (Sun Pharma) response to the US import ban on products produced at the company’s Gujarat site is inadequate, according to a warning letter issued by the US Food and Drug Administration (FDA) on 7 May 2014.

Generic atypical antipsychotic drugs in Belgium

Generics/Research | Posted 02/06/2014

Health authorities are continually looking to increase the utilization of low cost generics to save considerable monies without compromising care, given the ever increasing pressure on available resources. Pressures are driven by ageing populations, the continual launch of new premium-priced drugs and stricter clinical management targets. The quest is enhanced by the number of standard drugs losing their patents in recent years.

FDA’s faster approval of generics to benefit Indian drugmakers

Generics/General | Posted 02/06/2014

Indian generics makers are set to benefit from performance goals set by the US Food and Drug Administration (FDA) as part of the Generic Drug User Fee Amendments of 2012 (GDUFA).

Novartis settles Gleevec lawsuit with Sun Pharma

Generics/News | Posted 02/06/2014

Sun Pharmaceutical Industries (Sun Pharma) announced on 15 May 2014 that it had reached a settlement agreement with originator drug developer Novartis over litigation concerning generic Gleevec (imatinib mesylate).

Impact of delisting ARBs in Denmark

Generics/Research | Posted 23/05/2014

Health authorities are looking to increase the utilization of low cost generics to save considerable resources without compromising care. This includes Denmark [1].

Natco tries to block hepatitis C patent in India

Generics/General | Posted 23/05/2014

Indian generics maker Natco Pharma (Natco) has asked the Indian patent office not to issue a patent for US-based Gilead Sciences (Gilead) new hepatitis C drug Sovaldi (sofosbuvir).

Pharmacists’ attitudes towards generics in Czech Republic

Generics/Research | Posted 16/05/2014

A study carried out in the Czech Republic found that whether pharmacists routinely carried out generics substitution depended on their familiarity with the relevant legislation and their attitude towards generics substitution [1].

Blood pressure generics to be included in FDA’s testing plans

Generics/News | Posted 16/05/2014

The US Food and Drug Administration (FDA) is planning an extensive study of blood-pressure drugs after receiving thousands of complaints from doctors and patients.

Generics applications under review by EMA – April 2014

Generics/General | Posted 09/05/2014

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].

FDA sued over generic celecoxib approval

Generics/News | Posted 09/05/2014

Generics makers Actavis and Mylan Pharmaceuticals (Mylan) have sued the US Food and Drug Administration (FDA) over the agency’s decision to award exclusive rights to Teva Pharmaceutical Industries (Teva) to sell a generic version of Pfizer’s blockbuster anti-inflammatory painkiller Celebrex (celecoxib).

Attitudes towards generics in Turkey

Generics/Research | Posted 02/05/2014

Prescribers, pharmacists and patients in Turkey lack knowledge about generics. They may also be misinformed about generics, which can cause hesitation about the use of these drugs, according to Toklu and co-authors from the University of Istanbul, Turkey [1].

UK launches generic medicines forum

Generics/General | Posted 02/05/2014

The UK’s drug regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA) and the British Generic Manufacturers Association (BGMA) announced on 16 April 2014 the launch of a new forum to promote the manufacturing quality of generics.

Free samples increase use of branded drugs

Generics/Research | Posted 25/04/2014

The practice of giving free samples to physicians to give out to their patients increases the use of brand-name drugs, according to research published in JAMA Dermatology [1].

FDA defends generics labelling proposal

Generics/General | Posted 25/04/2014

The US Food and Drug Administration’s (FDA) Director of the Center for Drug Evaluation and Research, Dr Janet Woodcock, testified before the Subcommittee on Health, Committee on Energy and Commerce of the US House of Representatives on 1 April 2014, to discuss FDA’s proposed labelling rule for generics.

Positive impact of a value-based approach to health care

Generics/Research | Posted 18/04/2014

A study into the use of value-based benefit design (VBBD) for members of an employee health benefits programme demonstrated that such a programme can have a positive impact on adherence and cost outcomes [1].

Results of clinical trials in Europe to be made publicly available

Generics/General | Posted 18/04/2014

It will soon be the law in Europe for all clinical drug trials to be registered and the results reported on a publicly-accessible database. Members of the European Parliament (MEPs) voted on 2 April 2014 by a huge majority to adopt the Clinical Trials Regulation, 547 in favour, 17 against and 13 abstaining.

FDA discredits study claiming foreign generics tainted

Generics/General | Posted 11/04/2014

Research suggesting that foreign generics are inferior to US generics has been discredited by the FDA’s Center for Drug Evaluation and Research Director Dr Janet Woodcock.

Taiwan TWi gains FDA approval for generic nifedipine

Generics/News | Posted 11/04/2014

Taiwan’s TWi Pharmaceuticals (TWi) announced on 7 April 2014 the approval of its abbreviated new drug application (ANDA) for generic nifedipine by the US Food and Drug Administration (FDA).

Prescribers, pharmacists and patients in Turkey believe generics differ from originators

Generics/Research | Posted 04/04/2014

A study carried out by Toklu and co-authors from the University of Istanbul, Turkey, has shown that many prescribers, pharmacists and patients in Turkey believe that generics differ from their originators [1].

Dr Reddy’s launches generic amlodipine/atorvastatin

Generics/News | Posted 04/04/2014

Indian generics giant Dr Reddy’s announced on 27 March 2014 the launch of its generic amlodipine/atorvastatin tablets in the US.

The non-financial benefits of generics substitution

Generics/Research | Posted 28/03/2014

Switching between different generic brands of metformin is a good cost-effective approach that does not adversely affect the quality of care for patients with type 2 diabetes, according to the results of a retrospective study in Taiwan.

EGA calls for removal of competition and trade barriers for generics

Generics/General | Posted 28/03/2014

The European Generic medicines Association (EGA) is calling on the EU to remove barriers to competition and free trade by introducing common sense reforms to European pharmaceutical intellectual property rules.

Celecoxib generics could come sooner than expected

Generics/News | Posted 28/03/2014

Pharma giant Pfizer confirmed on 12 March 2014 that the United States District Court for East Virginia had invalidated its reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in its blockbuster anti-inflammatory painkiller Celebrex.

FDA increases oversight of drug safety in India

Generics/General | Posted 21/03/2014

The US Food and Drug Administration (FDA) has created an Office of Pharmaceutical Quality in response to quality concerns at home and abroad, particularly surrounding generic medicines from several Indian manufacturing plants [1].

Indian generics makers face US recalls

Generics/News | Posted 21/03/2014

Indian generics makers are once again coming under US Food and Drug Administration (FDA) scrutiny.

Generics contribution to availability of essential medicines

Generics/Research | Posted 14/03/2014

The creation of Essential Medicines Lists (EMLs) within country healthcare systems is promoted by the World Health Organization (WHO) in order to improve the availability and use of medicines considered essential.

Brand-name drugs also cut healthcare costs

Generics/General | Posted 14/03/2014

Generics are often given all the praise when it comes to cutting costs for patients and payers, but, according to a piece in Forbes, brand-name drugs also cut healthcare costs.

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).