Generics
Generics applications under review by EMA
Last update: 6 September 2013
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 27 EU member states and in Norway, Iceland and Liechtenstein. 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].
Bayer loses Nexavar compulsory licence appeal
Bayer has lost its appeal to the Indian Government’s decision to grant a compulsory licence for its cancer drug Nexavar (sorafenib).
Suggestions for increasing generics use in Abu Dhabi
This concluding article in a series of three suggests ways of improving the use of generics in Abu Dhabi.
Use of generics in Abu Dhabi
The second of three articles examining how to increase generics use in Abu Dhabi.
Canada takes another step towards generics
For the first time, two of Canada’s biggest health insurance companies are going to require that generics be prescribed if one is available.
Hospira acquires manufacturing, R & D facilities in India
On 29 August 2012, US-based Hospira announced an agreement to acquire an API (active pharmaceutical ingredient) manufacturing facility, together with an associated research and development (R & D) facility, from Orchid Chemicals & Pharmaceuticals. The modern, FDA-approved facility is costing approximately US$200 million. Acquisition of this leading Indian pharmaceuticals company is expected to reduce Hospira’s costs, support continuity of supply of key antibiotic products and pave the way for future API development [1].
Maximising the potential of generics in Abu Dhabi
Introduction
All residents in Abu Dhabi have access to health care via mandatory health insurance. Nationals, who comprise 20% of the population with two-thirds under 30 years of age and half under 19 years of age, have automatic access to comprehensive health care funded by the government. In 2008, all nationals received cards giving free access to health care and choice of provider in both the public and private sectors [1].
Mylan generics launches in the US
Mylan has 166 abbreviated new drug applications (ANDAs) pending Food and Drug Administration approval representing US$78.4 (Euros 61.3) billion in annual sales. Thirty-five of these are potential first-to-file opportunities, representing US$25.1 (Euros 19.6) billion in annual brand sales (2011 IMS Health figures).
Poor quality pharma ingredients abound in China
Lack of regulatory enforcement in China is allowing poor quality pharmaceutical ingredients to be sold to drug manufacturers with potentially dangerous or even fatal consequences for patients.
Impax settles patent dispute with Genzyme
Impax Laboratories (Impax) announced on 4 September 2012 that it had reached an agreement with Sanofi subsidiary, Genzyme Corporation (Genzyme), to settle pending US litigation with regard to the production and sale of generic versions of Renvela (sevelamer carbonate) and Renagel (sevelamer hydrochloride).
