This second edition of the EGA biosimilars handbook is intended to be a convenient and brief reference source for all those who need to understand biosimilar medicines, this relatively new subclass of biopharmaceutical products. It explains their importance and benefits and provides answers to the many questions raised by this vital new category of medicine. This handbook is particularly targeted towards all those groups that need to understand the background of biosimilar medicines
Producers of generic medicines are raising concerns on the huge cost implications of possible new anti-falsification technologies that will be required as a result of Directive 2011/62/EU on falsified medicines. The EGA (representing generic medicines producers), whilst fully supportive of the European Union and other international initiatives in their fight against counterfeit and falsified medicines, stresses that the threat to patients comes from falsification of well-known branded products and not low priced generic medicines. The scope of counterfeiting in medicines is like any other sector (such as clothing or electronics) where criminal activities are driven by price and demand, especially targeting well-known brands. There are no reports of generic medicines found falsified in the EU legal supply chain. Generic medicines should even be considered as preventing the falsification of medicines as they trigger competition, resulting in lower prices, and fragment the market into multisource volumes, which are unattractive for counterfeiters.
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“The need for a framework which allows global biosimilars development is now crucial” announced EGA President Gudbjorg Edda Eggertsdottir in her opening address at the 10th EGA International Symposium on Biosimilars today in London. Taking the critical example of the huge increase in diabetes in the coming years, EGA’s President highlighted that the access to affordable biosimilar insulin will be key for treating millions of patients worldwide. “Biosimilars will also promote significant cost savings that help to safeguard the sustainability of European and indeed global healthcare systems while ensuring access to high standard treatment for patients” Ms Eggertsdottir said. More..
“The revision of the Transparency Directive must be viewed as an opportunity to implement certain key recommendations of the Pharmaceutical Sector Inquiry which identified reasons why generic medicines are blocked or delayed from entering the market. We therefore welcome the European Commission’s decision to take on board measures that will help guarantee that generic medicines will continue to be made available to as many patients as quickly as possible at affordable prices” said Greg Perry, EGA Director. More..
The European Generic medicines Association (EGA) together with the Italian association for generic medicines (ASSOGENERICI) welcome the European Commission’s formal call yesterday on Italy to comply with EU rules on the marketing authorisation of generic medicines. The European Commission infringement procedure started last year, following the EGA and ASSOGENERICI’s official complaint to the European Commission against the delays in granting market authorisation of generic medicines caused by incorrect linkage to intellectual property rights. More..
Meeting today in Warsaw, the European Generic medicines Association’s Board announced the election of Gudbjorg Edda Eggertsdottir as its new President. Ms Eggertsdottir has been active in the generic medicines industry for over 30 years, witnessing the many challenges it has already faced on its way to becoming an essential part of the global healthcare offering. She has an impressive industry pedigree, which includes significant experience in the generic medicines sector in companies such as Actavis – where she is currently President Iceland, Strategic Projects – and Delta. Ms Eggertsdottir has been part of the EGA Executive Board for two years. More..
“The EGA is the official representative body of the European generic and biosimilar pharmaceutical industry, which is at the forefront of providing high-quality
affordable medicines to millions of Europeans and stimulating competitiveness and innovation in the pharmaceutical sector.”
18th EGA Annual Conference