Generics/General
AAM tries to block ‘unconstitutional’ drug pricing law
The Association for Accessible Medicines (AAM) has filed a lawsuit against the Attorney General of Maryland in an attempt to block a recently passed law which could affect national commerce in the US and harm the market for generic drugs, which saved Maryland over US$4 billion in 2016.
FDA lists drugs without generics to increase competition
The US Food and Drug Administration (FDA) announced on 27 June 2017 that it had taken ‘two new, important steps’ to increase competition and encourage the entry of generics in the US.
UK introduces new law to control generic drug prices
A new law introduced in the UK is seeking to clarify and extend the government’s powers to regulate the cost of medicines and medical supplies and to collect sales and pricing information from pharmaceutical companies.
Baxter and Dorizoe make deal for generic injectables
US-based healthcare company Baxter International (Baxter) and contract research and development organization Dorizoe announced on 14 June 2017 that they have made a deal for generic injectables.
FDA targets rising drug prices by increasing generics competition
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb is advocating reducing drug costs by approving cheaper generics faster.
Japan plans to increase generics use
Japan is currently the world’s second largest pharmaceutical market. Prescription brand-name drugs dominate the market and generics constitute only around 56% of total sales. However, the Japanese Government wants to change that.
Call to phase out branded drugs in India
Doctor and patient associations have come together to suggest that the Indian Government phase out branded generics and ban differential pricing under different brands to promote generic drug prescriptions.
Generics and biosimilars: status in the EU
According to Medicines for Europe, without generic medicines Europe would have paid Euros 100 billion more for its medicines in 2014 alone. In a recent interview, the Association’s President Jacek Glinka spoke about the central issues surrounding the affordability and accessibility of medicines in the region.
Concerns over change to generics prescribing in Australia
In its 2017 budget, Australia is set to make changes that will encourage the use of generics and that are estimated could save the country AU$1.8 billion.
Generics applications under review by EMA – April 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].
