Generics

Allergan allows Amneal to market Alzheimer’s generic in 2025

Generics/News | Posted 23/09/2016

Allergan has reached a deal with Amneal Pharmaceuticals (Amneal) over Allergan’s Alzheimer’s drug Namzaric. The agreement will enable Amneal to market generic versions of the drug from 2025 onwards.

South Africa’s expedited registration policy not speeding up access to biosimilars

Generics/Research | Posted 16/09/2016

Since South Africa’s National Department of Health (DoH) implemented a fast-track registration policy in 2003 the large number of generics applications has led to a backlog in approvals [1]. This has led to concern that this backlog is having a detrimental effect on patient access to critical pharmaceutical medicines and in particular biosimilars [2].

Patent wins and losses for Teva

Generics/News | Posted 16/09/2016

Teva Pharmaceutical Industries (Teva) – the world’s largest generics manufacturer – has reported a string of patent updates recently. In the first of Teva’s patent-related news, Forest Laboratories (Forest) – an American pharmaceutical company acquired by Actavis [1] – made a deal with Teva regarding a patent licensed to them and held by Mayne Pharma (an Australian specialty injectables company now owned by Pfizer).

Generics applications under review by EMA – August 2016

Generics/General | Posted 16/09/2016

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].

South Africa’s expedited registration policy for rapid access to critical medicines under threat by generics

Generics/Research | Posted 09/09/2016

In 2003, the National Department of Health (DoH) of South Africa implemented a fast-track registration policy, not only for new chemical entities (NCEs) considered essential for national health and which may not be on the Essential Medicines List (EML) of South Africa, but also for all medicines on the EML, the majority of which are generics [1].

Driving down drug prices: how regulators can influence affordability

Generics/Research | Posted 02/09/2016

In recent years there has been increasing global concern over drug prices and their affordability. And what is the role played by regulators in drug pricing? This is the subject of discussion in a recent paper co-authored by the European Medicines Agency’s (EMA) Executive Director Guido Rasi, its Senior Medical Officer Hans-Georg Eichler, the Executive Director of Dutch Medicines Evaluation Board Hugo Hurts, and the President of the German Federal Institute for Drugs and Medical Devices Karl Broich [1]. Although the price of medicines is not within the regulatory remit, the authors find this an inescapable subject for debate and they outline possible regulatory interventions that could drive down drug prices.

Indian generics manufacturer Lupin buys 21 brands from Japan’s Shionogi

Generics/General | Posted 02/09/2016

India’s third biggest drug producer Lupin Ltd (Lupin) has announced that it will purchase 21 generic medicine brands from Japanese company Shionogi & Co Ltd (Shionogi) for a total of US$150 million, bolstering its position in the large Japanese pharmaceutical market.

Senators continue to raise concerns over price of Mylan’s EpiPen

Generics/News | Posted 02/09/2016

On 30 August 2016, a group of 20 US senators led by democrat Elizabeth Warren sent a letter to Mylan’s CEO Heather Bresch expressing their ‘serious concerns’ about the company’s recent significant price hikes for the life-saving EpiPen Auto-Injector.

Generics in seizure control

Generics/Research | Posted 26/08/2016

Are generic medicines for the control of epileptic seizures bioequivalent to their brand-name counterparts? Steven Karceski [1] has recently reviewed a study carried out by researchers at the Johns Hopkins University School of Medicine, Baltimore, MD, USA in which they determine the bioequivalence of generic seizure control medications [2].

New generic versions of imatinib mesylate join the US market

Generics/News | Posted 26/08/2016

Two new generic versions of Novartis’ imatinib mesylate (marketed as Gleevec® and Glivec®) were launched in the US in early August 2016.

EMA halts sales of unreliable generics

Generics/General | Posted 19/08/2016

The European Medicines Agency (EMA) has recommended that the sales of several generics, including those produced by Teva and Novartis, be suspended after data on their approval was found to be unreliable.

Launches, approvals and court cases for Sun Pharma

Generics/News | Posted 19/08/2016

India’s largest drug manufacturer Sun Pharmaceutical Industries (Sun Pharma) has launched ready-to-administer anticancer drug gemcitabine in six European countries and gained approval for a generic version of prescription cholesterol medicine Crestor, while also facing legal action from protesting employees.

FDA approves first generic nilutamide for treatment of prostate cancer

Generics/News | Posted 12/08/2016

US generics producer ANI Pharmaceuticals (ANI) announced on 18 July 2016 that it had received US Food and Drug Administration (FDA) approval for its generic version of prostate cancer treatment Nilandron (nilutamide).

The satisfaction of healthcare payers, patients and physicians with generic imatinib

Generics/Research | Posted 05/08/2016

With the begining of the era of tyrosine kinase inhibitors (TKIs), chronic myeloid leukaemia (CML) became a chronic disease, in which good responding patients usually have a life expectancy similar to the age- and sex-matched normal population [1]. In many countries, the first-line treatment of chronic phase CML is imatinib mesylate (IM). Whereas, especially in some developed countries, second generation TKIs (dasatinib, nilotinib) which have deeper and faster responses, but are also more expensive than IM, are utilized in the upfront setting. The introduction of TKIs increased the prevalence of CML, and optimal responders to IM should continue therapy indefinitely, so the originator TKI treatment (Gleevec) surely put a strain on healthcare providers even in developed countries.

Extortionate increases in prices of 32 drugs a result of loophole in NHS pricing structure

Generics/General | Posted 05/08/2016

An investigation by The Times has exposed a small group of UK-based entrepreneurs to have profited vast amounts of money from hiking up the costs of 32 medicines for common conditions by GBP 262 million a year, a 12,500% increase.

Ways to reduce drug costs in Australia

Generics/Research | Posted 29/07/2016

Drug costs in Australia are increasing at an alarming rate. This is driven mainly by expensive biological therapies, antiviral therapies for HIV and hepatitis C and new cancer treatments.

AES position statement on substitution of generic anti-epileptics

Generics/Research | Posted 01/07/2016

A paper by the American Epilepsy Society (AES) discusses how the society’s position on generics substitution of anti-epileptic drugs has changed according to the results of bioequivalence studies [1].

Healthcare alliance proposes ways to reduce drug costs in the US

Generics/General | Posted 01/07/2016

Recent price increases in the US have prompted an alliance of doctors, pharmacists and health plan groups to release a document that outlines 12 policy proposals that it hopes will provide the framework for a major debate in Congress.

Reasons for the success of a generics company in the Sudan market

Generics/Research | Posted 24/06/2016

An exploratory, qualitative study carried out by colleagues from the University of Khartoum (Sudan) and Abertay University (UK) examined the reasons behind the success of a generics company that has been the market leader in Sudan for a decade from the perspective of employees and customers [1].

Glenmark gains approval for anti-epileptic generic

Generics/News | Posted 24/06/2016

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 19 May 2016 that it had received final approval from the US Food and Drug administration (FDA) for a generic version of Eisai’s epilepsy treatment Banzel (rufinamide).