Generics/General
Generics applications under review by EMA – April 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].
FDA approves highest number of generics in 2015
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).
India’s bulk drug exports on the increase
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.
Lupin and Gavis to divest generics to appease US FTC
Lupin Pharmaceuticals (Lupin) and Gavis Pharmaceuticals (Gavis) have reportedly agreed to sell two generics in order to finalize Lupin’s acquisition of Gavis.
FDA lifts import ban on Chinese API to prevent shortages
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’.
Hilary Clinton goes after Valeant for ‘predatory pricing’
Presidential candidate Hilary Clinton has said in a new advertisement that she is ‘going after’ drugmaker Valeant Pharmaceuticals (Valeant) for its ‘predatory pricing’.
Medicines Patent Pool signs first sub-licences for HCV med daclatasvir
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).
European generics and biosimilars makers adopt disclosure rules
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.
Generics applications under review by EMA – December 2015
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].
Proposed rebates will hit patients, not drug companies
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).
