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Generics/General

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First prequalification submissions for generic dolutegravir

Generics/General | Posted 25/11/2016

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.

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Sandoz petitions FDA over requirements for generics of Advair Diskus

Generics/General | Posted 04/11/2016

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.

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Why do generic drug prices keep on rising?

Generics/General | Posted 23/09/2016

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. 

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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].

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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.

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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.

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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.

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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.

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China cuts prices for three drugs by more than 50%

Generics/General | Posted 17/06/2016

In an effort to lower spending on prescription drugs, China has cut the prices for three patent-protected drugs by more than 50%.

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Australian generics maker opens clinical trials facility

Generics/General | Posted 20/05/2016

IDT Australia announced on 2 May 2016 that it had opened a new clinical trials facility in Adelaide.

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Generics applications under review by EMA – April 2016

Generics/General | Posted 13/05/2016

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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FDA approves highest number of generics in 2015

Generics/General | Posted 06/05/2016

The US Food and Drug Administration (FDA) approved more than 700 generics in 2015, more than in any previous year, according to the annual report from the agency’s Office of Generic Drugs (OGD).

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India’s bulk drug exports on the increase

Generics/General | Posted 29/04/2016

Driven by exports to both regulated and semi-regulated markets, India’s bulk drug exports are likely to grow at a compound annual growth rate (CAGR) of 12–14% up to 2018–2019, according to a recent study.

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Lupin and Gavis to divest generics to appease US FTC

Generics/General | Posted 25/03/2016

Lupin Pharmaceuticals (Lupin) and Gavis Pharmaceuticals (Gavis) have reportedly agreed to sell two generics in order to finalize Lupin’s acquisition of Gavis.

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FDA lifts import ban on Chinese API to prevent shortages

Generics/General | Posted 18/03/2016

The US Food and Drug Administration (FDA) has lifted its ban on one of the active pharmaceutical ingredients (APIs) from China-based Zhejiang Hisun Pharmaceutical (Hisun) due to a ‘critical drug shortage concern’.

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Hilary Clinton goes after Valeant for ‘predatory pricing’

Generics/General | Posted 11/03/2016

Presidential candidate Hilary Clinton has said in a new advertisement that she is ‘going after’ drugmaker Valeant Pharmaceuticals (Valeant) for its ‘predatory pricing’.

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Medicines Patent Pool signs first sub-licences for HCV med daclatasvir

Generics/General | Posted 04/03/2016

The Medicines Patent Pool (MPP) announced on 20 January 2016 the signing of its first sub-licences for generics of Bristol-Myers Squibb’s hepatitis C medicine Daklinza (daclatasvir).

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European generics and biosimilars makers adopt disclosure rules

Generics/General | Posted 19/02/2016

The European Generic and Biosimilar Medicines Association (EGA) has published disclosure rules for the generic, biosimilar and value added medicines industry. This builds on the EGA Code of Conduct adopted in 2015. 

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Generics applications under review by EMA – December 2015

Generics/General | Posted 05/02/2016

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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Proposed rebates will hit patients, not drug companies

Generics/General | Posted 27/11/2015

Attempts by US Congress to halt the rise in generics prices with new rebates payable by drugmakers has received a stinging rebuff from the Generic Pharmaceutical Association (GPhA).