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Novo Nordisk becomes second pharma company to cap price hikes

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

Generics regulators outline priorities to 2020

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

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].

UK competition authority accuses Actavis of overcharging NHS

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

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

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.

First prequalification submissions for generic dolutegravir

The Medicines Patent Pool (MPP) announced on 10 November 2016 that two of its generics manufacturing partners are the first companies to apply for prequalification of generic dolutegravir, a new antiretroviral that the MPP licensed from ViiV Healthcare in 2014.

Sandoz petitions FDA over requirements for generics of Advair Diskus

Sandoz has asked the US Food and Drug Administration (FDA) not to approve generics of GlaxoSmithKline’s (GSK) chronic obstructive pulmonary disorder (COPD) treatment Advair Diskus (fluticasone/salmeterol), unless the generics applications contain the results of pharmacokinetic (PK) bioequivalence studies that ‘ensure the safety and efficacy’ of the products.

Why do generic drug prices keep on rising?

Consumers are paying more and more for their drugs, and especially in the US. The US allows manufacturers to set their own prices for drugs, leading to overall medicine costs being higher than anywhere else. More and more, insurance companies are passing on these higher costs to consumers. 

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].

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