Generics

Canada bans imports from three API facilities in India

Generics/General | Posted 17/10/2014

Just days after Canada’s federal department responsible for health was reported to be in talks with the US Food and Drug Administration (FDA) about Canadian generics maker Apotex, Health Canada has announced that it is to ban imports from two of Apotex’s facilities and from one site belonging to IPCA Laboratories in India.

Generics in Taiwan: urban–rural disparity

Generics/Research | Posted 10/10/2014

A study of the urban–rural disparity of prescribing generic versus brand-name drugs in Taiwan has found that the generics prescribing ratio of the most popular anti-hypertensive (high blood pressure) medicines is reversely associated with the level of urbanization [1].

Thirty years of generics in the US

Generics/General | Posted 10/10/2014

On 24 September 2014, the US Food and Drug Administration (FDA) celebrated 30 years of generics in the US.

Actavis agrees to continue making Alzheimer’s drug for now

Generics/News | Posted 10/10/2014

Actavis has agreed to keep selling a top Alzheimer’s disease drug for 60 days so US patients will not be forced to switch to a newer, more expensive form of the drug.

European initiatives to enhance losartan utilization post generics: impact and implications

Generics/Research | Posted 03/10/2014

Health authorities have the opportunity to realize considerable savings from generics. A wide variety of strategies were instigated across Europe to encourage prescribing of losartan once generics became available with all angiotensin receptor blockers (ARBs) – which are used to treat high blood pressure and heart failure – seen as essentially similar at appropriate doses [1, 2]. These ranged from 100% co-payment for single-sourced ARBs in Denmark to removing prescribing restrictions for losartan but not for single-sourced ARBs (Austria and Belgium), to prescribing targets and therapeutic switching programmes in Sweden [3]. However, some authorities instigated no specific measures, e.g. Ireland, Scotland and Spain (Catalonia) [3, 4], providing an opportunity to assess the effectiveness of different measures.

New indication for old generic combination drug

Generics/News | Posted 03/10/2014

US biopharmaceutical company Avanir Pharmaceuticals has announced positive results from a phase II clinical trial of a generic combination drug for the treatment of agitation in patients with Alzheimer’s disease. The same combination is already approved for a different neurological disorder, and other indications are being investigated.

The ethics of generic immunosuppressive drugs

Generics/Research | Posted 26/09/2014

A literature review of generic immunosuppressive drugs (ISDs) in renal transplant patients concludes that it is ethical to prescribe generic ISDs provided regulatory safeguards are met. Alongside these safeguards, it will be essential to educate patients and to carry out further clinical and health economic studies to inform clinicians, patients and society of the risks and costs of drug substitution [1].

Phase III trials for generic asthma inhaler and insulin glargine

Generics/News | Posted 26/09/2014

Generics giant Mylan is set to embark on phase III clinical trials of its generic fluticasone/salmeterol inhaler for asthma patients.

Generics taskforce for Australia

Generics/General | Posted 26/09/2014

Australia’s Generic Medicines Industry Association (GMiA), which represents companies that manufacture, supply and export generics, has called on the country’s Minister for Industry to convene a Medicine Manufacturing Taskforce.

FDA approvals for generic AIDs and testosterone drugs

Generics/News | Posted 19/09/2014

The US Food and Drug Administration (FDA) has approved generic versions of drugs to treat appetite loss in AIDs patients and a testosterone gel treatment for men.

Generics applications under review by EMA – August 2014

Generics/General | Posted 19/09/2014

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].

Pharma’s future in China and the US

Generics/Research | Posted 12/09/2014

Although generics will increase their share of all prescriptions in China and the US over the next 10 years, economic and structural incentives for new drug invention and brand-name prescribing by physicians will keep the share of patented drug sales high compared with countries that have more direct government control over the pharmaceutical market [1].

Generic hepatitis drug to be made available to 80 countries

Generics/General | Posted 12/09/2014

Originator pharma company Gilead Sciences (Gilead) is reportedly close to reaching a deal with generics makers to bring low cost versions of its hepatitis C drug Sovaldi (sofosbuvir) to about 80 developing countries including India, Indonesia, and Pakistan, as well as Egypt, Mongolia, South Africa, and Vietnam.

Teva wins another Symbicort patent challenge

Generics/News | Posted 12/09/2014

Teva Pharmaceutical Industries (Teva) has gained another win in its campaign to launch a generic version of AstraZeneca’s asthma and chronic obstructive pulmonary disorder (COPD) treatment Symbicort (formoterol/budesonide) in Europe.

Appropriate generics pricing improves medicines availability in Sri Lanka

Generics/Research | Posted 05/09/2014

The wide availability of generics across Sri Lanka, in both private and semi-government community pharmacies, is increasing the availability and affordability of essential medicines for non-communicable diseases (NCDs) in the country.

Generics companies sue Reckitt Benckisser over generics supplies

Generics/News | Posted 05/09/2014

Three generics companies are suing Reckitt Benckisser (Reckitt) for failing to provide generics supplies of its cold and flu medicine Mucinex (guaifenesin) in line with an agreement struck in 2007.

Value of generics overlooked in one country that needs them most: Greece

Generics/Research | Posted 29/08/2014

A study of physicians’ prescribing patterns and perceptions towards generics in Greece has revealed a clear need for an appropriate regulatory framework and organized generic drug industry in the country.

Lawyers look at new price hike for old drug

Generics/General | Posted 29/08/2014

Two generic drug companies are being investigated by the Connecticut Attorney General’s office following reports of alarming price hikes for the heart medicine digoxin. Possible price fixing by Impax Laboratories (Impax) and Lannet, which manufacture digoxin, is being investigated.

US court puts generic Gralise on hold

Generics/News | Posted 29/08/2014

US specialty drugmaker Depomed has received a favourable preliminary verdict in its case against generics manufacturer Actavis, which had applied to market a generic version of Depomed’s treatment for neuropathic pain, Gralise (gabapentin).

Trends in the financial burden of diabetes treatment

Generics/Research | Posted 22/08/2014

The number of adults diagnosed with diabetes in the US increased 75% between 2000 and 2010, resulting in 9% of the adult population with diabetes. The cost of health care for people with diabetes is over twice that of the population overall (2.3 times higher), partly as a result of complications associated with diabetes, including heart disease and stroke. Understanding trends in healthcare costs for this vulnerable and growing patient group will be key to disease management in the future.

Generics manufacturers focus on MS drug Ampyra

Generics/News | Posted 22/08/2014

Following news that Acorda Therapeutics (Acorda) was preparing to defend its intellectual property rights against a competitor’s application to the US Food and Drug Administration (FDA) to manufacture a generic version of its multiple sclerosis drug Ampyra (dalfampridine), Acorda is now facing at least six additional generics challenges.

Ranbaxy’s manufacturing woes benefit big pharma

Generics/General | Posted 22/08/2014

Import bans by the US Food and Drug Administration (FDA) on generics from four of Ranbaxy Laboratories’ (Ranbaxy) manufacturing sites have prevented the company from launching new generics, allowing brand-name manufacturers to benefit from their extended monopolies.

Right of appeal provision in CETA

Generics/Research | Posted 14/08/2014

The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1], with certain provisions being seen as causing the most harm.

Recalls call into question metoprolol generics

Generics/General | Posted 08/08/2014

Recent recalls have vindicated a cardiologist’s warnings about generic versions of a widely used heart drug, Toprol XL (metoprolol).

Actavis submits generic dalfampridine ANDA

Generics/News | Posted 08/08/2014

Acorda Therapeutics (Acorda), announced on 26 June 2014 that it had received a Paragraph IV Certification Notice Letter advising the company that Actavis Laboratories (Actavis) had submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for the approval of a generic version of the company’s multiple sclerosis drug, Ampyra (dalfampridine).

Data protection provisions in CETA

Generics/Research | Posted 01/08/2014

The trade agreement between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1]. In particular, certain intellectual property provisions are seen as the main culprits.

Generic valsartan approved in US

Generics/News | Posted 01/08/2014

India’s largest generics maker Ranbaxy Laboratories announced on 27 June 2014 that its subsidiary, US-based Ohm Laboratories (Ohm), had received approval from the US Food and Drug Administration (FDA) for generic valsartan.

India planning to extend pricing control to more drugs

Generics/General | Posted 01/08/2014

India is thought likely to increase the number of drugs it considers ‘essential’ and therefore for which it controls the maximum retail price in the country.

Patent term restoration provisions in CETA

Generics/Research | Posted 04/07/2014

Some of the provisions included in the Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada are seen as having the potential to have a negative affect on the generics industry in Canada [1].

Teva settles patent litigation over ProAir HFA

Generics/News | Posted 04/07/2014

The world’s biggest generics maker, Teva Pharmaceutical Industries (Teva), announced on 20 June 2014 that it had reached a settlement with Perrigo Pharmaceutical (Perrigo) and Catalent Pharma Solutions (Catalent) with respect to Teva’s respiratory product ProAir HFA (albuterol sulfate).

Influence of CETA on generics

Generics/Research | Posted 27/06/2014

On 18 October 2013, the European Union (EU) and Canada reached a political agreement on the key elements for a Comprehensive Economic and Trade Agreement (CETA). However, CETA has been criticized for the fact that it affects intellectual property rights in Canada, but not the EU. Some of the provisions included in the agreement are seen as having the potential to have a negative affect on the generics industry in Canada.