Generics

Innovation in the generics industry

The decrease in innovation in the originator pharmaceutical industry is leading to an increase in innovation in the generics pharmaceutical industry, according to new research [1].

Indian FDA wants to increase use of generics

The Commissioner of Indian Food and Drug Administration (FDA) has denied allegations by physicians and pharmacists in India that the bioavailability of generic drugs is doubtful.

Actavis makes agreement for generic abuse-deterrent oxycodone

US generics maker Actavis (formerly Watson) announced on 26 April 2013 that it had reached an agreement with Purdue Pharma (Purdue) to settle all outstanding patent litigation related to Actavis’ generic version of Purdue’s abuse-deterrent formulation of OxyContin (oxycodone).

Quality of generics in South Africa

A study of the quality of generic medicines in South Africa has shown large differences in the perception and the actual quality of generics [1].

Daiichi Sankyo and Ranbaxy announce synergy in Brazil

India-based Ranbaxy Laboratories (Ranbaxy) and its Japanese parent company Daiichi Sankyo announced on 17 April 2013 plans to integrate their generic and brand-name drug business operations in Brazil.

Generics applications under review by EMA – 2013 Q1

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].

FDA is dragging its feet over oxycodone generics

The US patent for Purdue Pharma’s (Purdue’s) blockbuster painkiller OxyContin (oxycodone) expired on 16 April 2013, but FDA has yet to approve any generic versions. Now, FDA has announced that it will not approve any generics of the original formulation OxyContin.

Mylan gains approval for generic of Valeant’s Zovirax

Generics giant Mylan announced on 3 April 2013 that its subsidiary Mylan Pharmaceuticals had received final approval from FDA for its abbreviated new drug application (ANDA) for acyclovir ointment 5%.

AstraZeneca settles rosuvastatin lawsuit

UK-based AstraZeneca announced on 25 March 2013 that it had entered into a deal concerning US patent infringement litigation against Actavis (formerly known as Watson Pharmaceuticals) and EGIS Pharmaceuticals with respect to Actavis’ generic rosuvastatin zinc product.

Cost savings from use of generic medicines in Ireland

Ireland has one of the lowest usages of generics in the EU. However, in order to try to address this, the country introduced a new bill – Health (Pricing and Supply of Medical Goods) Bill 2012 – on 16 September 2012. Authors Dunne et al. discuss how the proposed changes could affect health care in Ireland [1].

New entrant to generic injectables market

Medical technology company Becton Dickinson announced on 28 March 2013 that FDA had approved the first drug in its line of prefilled generic injectables. This can only be good news for FDA who has been fighting to alleviate drug shortages in the US, most of which are due to shortages in generic sterile injectables.

Mylan launches generics and reaches settlement over metformin

Generics giant Mylan has launched generic versions of fenofibrate capsules, cidofovir injection and levalbuterol. The company has also resolved patent litigation with Shionogi and Andrx related to metformin.

Why choose generic medicines initiative launched in Australia

The Australian Generic Medicines Industry Association (GMiA) and the Pharmacy Guild of Australia announced on 22 March 2013 the launch of a joint initiative: Why choose generic medicines?

Use of generic medicines in Ireland

Ireland’s Department of Health and Children intends to introduce a system of reference pricing and generics substitution in Ireland, which will greatly increase the utilization of generics and generate significant cost savings, whilst at the same time, increasing the accessibility and affordability of essential medicines. Authors Dunne et al. discuss Ireland’s history with the use of generic medicines [1].

Changes in risperidone use in Austria after introduction of generics

Currently, many governments have introduced austerity reforms to control pharmaceutical expenditure. In Austria, efforts have been made to both increase the use and lower the prices of generics. The problem is that antidepressants are not like other drugs, such as cholesterol-reducing medicines, where switching from originators to generics is not seen as a problem. For antidepressants the patient’s treatment is often tailored to meet their specific needs and there is resistance to switch products in stable patients.

Actavis confirms generic Alzheimer’s patch patent challenge

US generics maker Actavis (formerly Watson) confirmed on 8 March 2013 that it had filed with FDA an amendment to its abbreviated new drug application (ANDA) for rivastigmine transdermal system to include the 13.3 mg/24 hr dosage strength. Actavis’ product is a generic version of Novartis’ Exelon Patch, which is used to treat people with mild to moderate dementia associated with Alzheimer’s or Parkinson’s disease.

Use of venlafaxine in Austria after introduction of generics

Trying to reduce expenditure on medicine is a major driving force for reforms by many governments. This includes Austria, where measures have been introduced to lower generics prices and enhance their use. However, the situation for newer antidepressants and atypical antipsychotic medicines (AAPs) is different to proton pump inhibitors (PPIs) (anti-reflux), statins (cholesterol-reducing), and renin-angiotensin inhibitor (blood-pressure reducing) drugs. For antidepressants therapy, it is more often tailored to meet the patient’s needs and there is resistance to switch products in stable patients.

India may move away from compulsory licensing

The Indian Government, in a move that goes away from recent decisions, has suggested that the prices of patented pharmaceutical drugs be controlled by linking them to the country’s per capita income rather than by issuing compulsory licences.

Mylan to acquire Strides Arcolab’s injectable generics business

Generics giant Mylan announced on 27 February 2013 that it has signed an agreement to acquire generic injectables maker Agila Specialties (Agila) from Strides Arcolab for US$1.6 billion in cash.

Patients’ knowledge and perceptions about generics in Australia

Most Australians know about generics but are not sure if they prefer brand-name or generic drugs, according to a survey carried out by Australian researchers and published in December 2012 in the Journal of Pharmacy Practice and Research [1].

UN urges WTO to keep cheap drug deal for poor countries

Two United Nations (UNs) agencies are urging the extension of an exemption for least-developed countries on patent protection to ensure that HIV/AIDS and other lifesaving drugs remain affordable for the poor.

Pfizer delays generic celecoxib entry in US

Pharma giant Pfizer announced on 5 March 2013 that the US Patent Office had given the company an extra 18 months of exclusivity for its blockbuster anti-inflammatory painkiller Celebrex (celecoxib).

FDA approves generic opiate-dependency drugs

On 22 February 2013, FDA approved two generic versions of the drug Suboxone (buprenorphine/naloxone), a treatment for recovering heroin addicts.

Ranbaxy restarts generic atorvastatin production

India-based generics giant Ranbaxy Laboratories (Ranbaxy) announced on 25 February 2013 that it has restarted production of its generic cholesterol lowering drug atorvastatin after solving contamination problems.

Pfizer asks US Court to reconsider generic Reglan ruling

Pfizer has asked the US Supreme Court of Alabama to reconsider its decision of 4 January 2013, which would allow generics patients to sue brand-name drugmakers.

Generics policies in Europe have room for improvement

In Europe, generics policies have not yet been implemented to their full extent, according to authors Vogler and Zimmerman, reporting on the 2011 Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference [1, 2].

Conflict-of-interest policies reduce brand-name prescribing

Psychiatrists who are exposed to conflict-of-interest (COI) policies during their residency are less likely to prescribe brand-name antidepressants after graduation than those who train in residency programmes without such policies, according to a new study by researchers from the Perelman School of Medicine at the University of Pennsylvania, USA [1].

Watson buys women’s health company Uteron

Generics giant Watson Pharmaceuticals, now known as Actavis, announced on 23 January 2013 that it has completed the acquisition of Belgium-based Uteron Pharma for US$150 million in cash up front, and up to US$155 million in potential future milestone payments.

Watson becomes Actavis

Watson Pharmaceuticals announced on 24 January 2013 that the company had officially adopted Actavis as its new global name under which it will now trade on the New York Stock Exchange.

HIV generics could significantly cut treatment costs

The US Government could save almost US$1 billion in the first year alone by using generic rather than brand-name drugs for the treatment of HIV patients, according to a study published in the Annals of Internal Medicine [1].

First generic versions of Duetact and Maxalt approved

First-to-file generics from Mylan and Sandoz have been approved by FDA for rizatriptan benzoate and pioglitazone hydrochloride/glimepiride tablets, respectively.

Generic antiepileptic drugs bioequivalent to brand-name drugs

Results of a study, reported by Dr Ravi Juluru and co-authors at the American Epilepsy Society’s 66th Annual Meeting, held in San Diego, USA on 30 November–4 December 2012, shows that generic slow-release drugs for seizure disorders are ‘equivalent’ to their brand-name counterparts [1].

Overview of research on regulatory issues for generics in 2012

Period: January to August 2012 

Regulatory issues are a challenge facing generics of all kinds, and one that may limit the competitiveness and sustainability of the generics industry. However, with the cost of medicines becoming a more and more important factor for patients and the healthcare industry as a whole there is a need for both harmonization of regulatory requirements between different regions, e.g. Canada, EU and US, as well as a need for clarity in the regulatory requirements for certain generics.

Pharmascience and Kolmar to create Korean generics joint venture

Canadian generics maker Pharmascience and Korea-based Kolmar Holdings (Kolmar) announced on 2 January 2013 that they had entered into an agreement to create a new joint venture, Pharmascience Korea, for the marketing of Canadian-made bioequivalent medicines.

Brand-name and generics labels don’t match

According to US federal law generics manufacturers have to have the same labelling as their brand-named counterparts. However, a new study has found that in practice this is often not the case.

Watson submits ANDA for generic cancer drug

Watson Pharmaceuticals confirmed on 28 December 2012 that Actavis, which was acquired by Watson in October 2012, has filed an Abbreviated New Drug Application (ANDA) with FDA seeking approval to market generic bortezomib. Actavis’ ANDA product is a generic version of Millennium Pharmaceuticals’ (Millennium) cancer drug Velcade (bortezomib).