Generics/General

Generics applications under review by EMA – April 2017

Generics/General | Posted 12/05/2017

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].

Indian drug industry faces setbacks in Europe and the US

Generics/General | Posted 21/04/2017

The European Medicines Agency (EMA) has announced that they have recommended the suspension of generic drug approvals and drug applications of over 300 drugs. This is due to unreliable bioequivalence studies carried out by the Indian contract research firm Micro Therapeutic Research Labs.

FDA commits to success of the generic and biosimilar second-generation user fee acts

Generics/General | Posted 14/04/2017

Representatives of the Centre for Drug Evaluation and Research (CDER), the Association of Accessible Medicines (AAM), the Biotechnology Innovation Organisation (BIO) and the Biosimilars Council Director reportedly testified on 8 March 2017 as to their commitment to the US Food and Drug Administration’s (FDA) recommendations for the second generation of user fee agreements covering both generics and biosimilars.

Malaysian Government approves new generics facility

Generics/General | Posted 03/03/2017

Bangladesh-based generics firm Beximco Pharmaceuticals (Beximco) has made a deal with Malaysia’s BioCare Manufacturing (BioCare) to manufacture and supply differentiated medical products in the country.

Novo Nordisk becomes second pharma company to cap price hikes

Generics/General | Posted 17/02/2017

Danish pharmaceutical company Novo Nordisk has pledged to limit the price rises of their drugs to single digit increases each year, following the commitment made by Allergan in September 2016.

Generics regulators outline priorities to 2020

Generics/General | Posted 27/01/2017

The International Generic Drug Regulatory Programme (IGDRP) announced on 21 December 2016 that it had released its ‘Roadmap to 2020’, which outlines the group’s priorities until 2020. The document outlines those priorities as including five initiatives geared toward harmonizing global regulations for generics.

Generics applications under review by EMA – December 2016

Generics/General | Posted 20/01/2017

UK competition authority accuses Actavis of overcharging NHS

Generics/General | Posted 13/01/2017

The UK’s Competition and Markets Authority (CMA) has accused Actavis of breaching competition law by increasing the price of generic hydrocortisone tablets by more than 9,500−12,000% compared to the brand-name product, which was sold by a different company prior to April 2008.

Competition does not curb high drug prices

Generics/General | Posted 06/01/2017

With increasing concern over price increases for medicines a new concern being raised is that increased competition in the pharma industry does not always lead to lower prices.

FDA reports record number of generics approvals

Generics/General | Posted 02/12/2016

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) latest activity report shows an increase in approvals for generics, including 835 tentative or full approvals issued for the fiscal year (FY) 2016.