Generics
Generics applications under review by EMA – April 2014
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 sued over generic celecoxib approval
Generics makers Actavis and Mylan Pharmaceuticals (Mylan) have sued the US Food and Drug Administration (FDA) over the agency’s decision to award exclusive rights to Teva Pharmaceutical Industries (Teva) to sell a generic version of Pfizer’s blockbuster anti-inflammatory painkiller Celebrex (celecoxib).
Attitudes towards generics in Turkey
Prescribers, pharmacists and patients in Turkey lack knowledge about generics. They may also be misinformed about generics, which can cause hesitation about the use of these drugs, according to Toklu and co-authors from the University of Istanbul, Turkey [1].
UK launches generic medicines forum
The UK’s drug regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA) and the British Generic Manufacturers Association (BGMA) announced on 16 April 2014 the launch of a new forum to promote the manufacturing quality of generics.
Free samples increase use of branded drugs
The practice of giving free samples to physicians to give out to their patients increases the use of brand-name drugs, according to research published in JAMA Dermatology [1].
FDA defends generics labelling proposal
The US Food and Drug Administration’s (FDA) Director of the Center for Drug Evaluation and Research, Dr Janet Woodcock, testified before the Subcommittee on Health, Committee on Energy and Commerce of the US House of Representatives on 1 April 2014, to discuss FDA’s proposed labelling rule for generics.
Positive impact of a value-based approach to health care
A study into the use of value-based benefit design (VBBD) for members of an employee health benefits programme demonstrated that such a programme can have a positive impact on adherence and cost outcomes [1].
Results of clinical trials in Europe to be made publicly available
It will soon be the law in Europe for all clinical drug trials to be registered and the results reported on a publicly-accessible database. Members of the European Parliament (MEPs) voted on 2 April 2014 by a huge majority to adopt the Clinical Trials Regulation, 547 in favour, 17 against and 13 abstaining.
FDA discredits study claiming foreign generics tainted
Research suggesting that foreign generics are inferior to US generics has been discredited by the FDA’s Center for Drug Evaluation and Research Director Dr Janet Woodcock.
Taiwan TWi gains FDA approval for generic nifedipine
Taiwan’s TWi Pharmaceuticals (TWi) announced on 7 April 2014 the approval of its abbreviated new drug application (ANDA) for generic nifedipine by the US Food and Drug Administration (FDA).
