Generics
Efficacy and safety of generic imatinib after switching
A study carried out by researchers from the US investigated switching from originator to generic imatinib in patients treated for chronic myeloid leukaemia [1].
Approval rating and opinion on generic drugs in Italy: a cross-sectional study in the Liguria region
Italy has the lowest generics market share by volume in Europe (less than 20%), coming just below Portugal and Spain. While in Northern European countries the introduction of generics took place between the 1970s and 1980s, in Italy the concept of generics was only clarified in 1996 (law n. 425) and physicians were only required to inform patients from 2012 [1].
Interchangeability of gabapentin generics
Researchers from The Netherlands and the US developed a model that could describe pharmacokinetic data for generic gabapentin in order to identify potential subpopulations of individual patients with increased risk for altered pharmacokinetics [1].
FDA denies Novo Nordisk petition to block generic liraglutide
On 5 January 2018, the US Food and Drug Administration (FDA) denied Novo Nordisk’s October 2017 citizen petition [1] that sought to block generic versions of its insulin Victoza (liraglutide) and two other liraglutide containing products. In 2016, Victoza (liraglutide) brought the company US$3.2 billion in sales.
Hospitals to start own generics company
In an effort to combat regular shortages and the increasing prices of drugs, four of the US’s largest hospital systems have made plans to create a non-profit generics company.
Treatment of chronic myeloid leukaemia patients with generic imatinib in Algeria
In a developing country like Algeria expensive therapies are not available. Alternative approaches are needed. In Algeria Imatib (imatinib: CIPLA-India) was introduced in 2006; however, no study has been published yet in the North Africa region regarding response and outcome of this generic drug in chronic myeloid leukaemia (CML) patients. Therefore, researchers from the Service d’Hématologie in Algeria and France carried out a multicentre study in newly diagnosed adult CML patients in the western region of Algeria. The aim of the study was to assess the effectiveness and safety of Imatib as a frontline therapy for patients with CML [1].
France fines J&J 25 million Euro for blocking generics
A fine of Euros 25 million was imposed on Janssen-Cilag and its parent company Johnson & Johnson (J&J) by the French Competition Authority on 20 December 2017. This occurred in response to a ruling that the company deliberately slowed market access to generic copies of its painkiller Durogesic (fentanyl) and sought to restrict the development of competing products.
Mylan appeals to FDA: no approval for generic Advair Diskus based on multi-batch PK BE studies
On 5 December 2017, Mylan filed a citizen petition asking the US Food and Drug Administration (FDA) not to approve any abbreviated new drug applications (ANDAs) for generic versions of Advair Diskus that rely on data from multiple-batch studies to demonstrate pharmacokinetic (PK) bioequivalence (BE). The agency’s guidance on evaluating generic bioequivalence for this Glaxo Smith Kline asthma drug, specifies a single-batch trial design and Mylan is requesting that this is adhered to.
Generics applications under review by EMA – January 2018
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].
The Greek problem of generics pricing
Over the past few decades spending on prescription pharmaceuticals has increased faster than total health spending and gross domestic product in most OECD (Organisation for Economic Co-operation and Development) countries [1, 2].
