FAQ
General / market: * Generics are subject to different legal definitions in different countries. The definition of generics as used in this context does not make reference to any particular legal definition.
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Patents further the public interest by giving a temporary monopoly to inventors of new products in return for sharing their knowledge with the broader scientific community. The temporary monopoly allows inventors to recoup their costs and make a reasonable profit. However, once the period of the patent is over, the knowledge enters the public domain and can be utilized by everyone. In the pharmaceutical industry, this is where generics come in.07-12-2007
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Most pharmaceutical companies will file a number of patents on any given medicine, to protect it against competition for as long as possible. Examples of patents are: composition of matter (the basic patent on the new chemical entity and its molecular structure), method of use (the process by which the medicine acts in the body), formulation (how the medicine is designed to enter the body, reach relevant organs and achieve the required effect).07-12-2007
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Data exclusivity is a separate and additional provision to patent protection for the reference medicine. It defines a period of time during which the generics applicant is restricted from applying for market authorization referencing the data developed for the reference product. Consequently, generic medicines can generally only be evaluated and approved after the data exclusivity period has expired. In the EU generics cannot be marketed until the market exclusivity has also expired.07-12-2007
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Market exclusivity means that no similar product is / may be on the market. The period of market exclusivity includes the data protection period and an additional period (e.g. two years in the EU) during which no generic version may be marketed. In the US generics industry, market exclusivity also refers to the 180-day period granted to the first approved generic version of an originator product. During this period, no other generics company may launch a version of the same product.07-12-2007
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Abbreviated new drug applications (ANDAs) are the submission required in the US to launch a generic version of an existing approved medicine. They are called abbreviated because fresh data on animal and human clinical studies is not required. Rather, the onus is on the producer to demonstrate bioequivalence to the reference product.07-12-2007
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This depends on the market and on the nature of the medicine. In the EU, for example, registration of a generic medicine usually takes one to two years, but can take longer - without taking account of initial development time. Moreover, in many EU member states, market access can be further delayed by having to wait for pricing and reimbursement status to be agreed. This is also the case for reference products.07-12-2007
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No. In fact, reference medicine data are never revealed to third parties; thus they cannot be used by generic producers. They must research and develop their own formulation of the product for approval. However, they may refer to published clinical data concerning the safety and efficacy of the reference product.07-12-2007
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An authorized generic is a medicine that was originally marketed and sold as a reference (branded) product, but is relabeled and marketed under a generic product name, usually once patent protection expires. It may be marketed by the brand company itself or through a subsidiary, or the brand company may license the product to another company in return for royalties. Authorized generics are sold at lower cost and as an alternative to the branded product. They do not have to respect the 180-day market exclusivity provision granted by the Hatch Waxman Act to the first generic on the market.07-12-2007
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Biosimilars, or follow-on proteins, are new versions of existing biopharmaceuticals whose patents have expired. They are produced using the same core genetic material and are approved on the basis that they are comparable to the reference product in terms of safety and efficacy. They are large, complex molecules produced by living organisms, which are highly sensitive to manufacturing changes; generics are small molecules, produced by chemical synthesis, which are usually very stable. Biosimilars is an official term used by the European medical authorities; the US terminology is follow-on protein products (FOPP). 07-12-2007
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From 2010 onwards, the patents of many major biopharmaceuticals will expire, paving the way for competition. Also, it is estimated that by 2010 some 50% of newly approved medicines will be biopharmaceuticals. All of these will eventually face patent expiry. In other words, biosimilars are a major future market for companies like Sandoz.07-12-2007
