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