A generic (plural generics ) or copycat is a drug that has the same active ingredients as a previously approved drug. The generic may differ from the original preparation in terms of auxiliary substances and manufacturing technology . It is subject to a simplified authorization in which documents from the original preparation are used, and is only produced after the patent protection of the original preparation has expired. The name of a generic is usually made up of the generic name ( INN ) of the active ingredient and that of the pharmaceutical company placing it on the market , but there are also generics with their own brand names ( branded generics ).
A generic should be therapeutically equivalent to the original product in its claimed indications , i.e. that is, it must correspond to its effectiveness and safety. This therapeutic equivalence is assumed for low molecular weight active substances if the statistical confidence range of the bioavailability of a generic is within 80% to 125% of the bioavailability of the original preparation ( bioequivalence ). In practice, the deviation from the original preparation is usually less than 5%.
The regulations for therapeutic equivalence of biological medicinal substances are still being discussed. In most cases, clinical studies in patients are still required today to prove therapeutic equivalence (see biosimilars ).
Generics are usually cheaper than the first-party drug because there are no research costs and the development costs for a generic are comparatively low. The Stiftung Warentest found in a study in September 2004 that the prices for generic drugs are sometimes only a third of the original product. Techniker Krankenkasse found even greater differences in 2014 in an inventory market report examining the costs and benefits of some drugs. When comparing the price comparisons between original products and generics of frequently prescribed rheumatism products , the original products were up to 20 times more expensive than comparable generics, and drugs for diabetes mellitus were up to a factor of 18. To save costs, which were statutory health insurance starting in 2007 based on the Economics of Law Pharmaceutical Care (AVWG) to about, with the help of discount agreements only basic budget preparations against to force drug manufacturers to pharmacies, regardless of the doctor's prescription insurances handed. In the case of existing discount contracts, the pharmacist must therefore dispense another drug with the same active ingredient (with the exception of any existing aut idem rule), which is very often a generic, instead of the original drug prescribed by name, in accordance with the health insurance company .
In order not to immediately lose the benefits achieved by pharmaceutical research to the generics manufacturers, the products developed by the researching drug manufacturers ( organized in Germany in the Association of Researching Pharmaceutical Manufacturers ) are protected by patents . The patent protection means that the original drugs have no competition from generics in the first few years after their market launch. But it also hinders the use of cheap new drugs in developing countries .
Among the oldest and best-known generics are preparations containing acetylsalicylic acid . The active ingredient originally developed by Bayer AG in Leverkusen and marketed in various pharmaceutical formulations under the name Aspirin is now part of numerous generics such as ASS Ratiopharm .
Legal barriers to entry of generics
The entry of generics into the market is restricted by various legal provisions. This includes, on the one hand, patent law, and on the other hand, document protection under pharmaceutical law also applies to the approval documents of the original manufacturer. As a rule, the market launch of generic drugs is only permitted ten to 15 years after the first approval of the reference drug.
The patent laws provide for a patent term of 20 years. Since pharmaceuticals have a long development time and have to go through a time-consuming approval process, which significantly reduces the effective market exclusivity, supplementary protection certificates have been introduced in the European Union and in other countries as well . According to Regulation (EEC) No. 1768/92 a patent holder can be granted such a certificate for five years; the duration of market exclusivity from the first drug approval is limited to a maximum of 15 years. Notwithstanding this, the patent or protection certificate can be extended by a further six months if the medicinal product is approved for a pediatric indication in accordance with Regulation (EC) No. 1901/2006 ( Pediatric Medicines Regulation ).
Regardless of patent protection, European Medicines Law provides in Directive 2001/83 / EC that generics may only be placed on the market ten years after the original product has been approved. If the original manufacturer receives approval in advance in other indications with significant clinical benefit compared to the existing therapies , this document protection will be extended to a maximum of 11 years. Only after this period has expired may the generic manufacturer refer to the results of the preclinical and clinical trials of the original manufacturer documented in the approval documents for the reference medicinal product.
According to its own statements, the EU wants to make it easier for European manufacturers to export generics and biosimilars to third countries through new rules . According to current law, it is forbidden in European countries to manufacture or sell drugs protected by patents or supplementary protection certificates , unlike in third countries where there is no patent law or where patents have expired. From 2019 there will be an exception to the patent protection of an original drug for export only, for manufacturing protected drugs and exporting them to countries without patent protection. Apart from this exception, the patent protection remains in full.
Approval of generic drugs
(MRP + DCP)
The approval of generics is basically based on the same principles as the approval of other drugs: the approval application must be accompanied by extensive qualitative documents, as is the case with all other drugs, as well as the corresponding clinical data. For the clinical data, however, bioequivalence studies are usually sufficient; in addition, the applicant may refer to the clinical data of the originator (“referring approval”). Since 2002, the evaluation of bioequivalence studies has to correspond to a guideline of the agency, which has been in force since August 2010 in a form revised by the “Pharmacokinetics Working Party” (working group of the Committee for Human Medicinal Products of the European Medicines Agency). Similar requirements apply in the USA, although in addition to the general guidelines currently (December 2012) more than 1000 product-specific guidelines must be observed.
In Europe, like other drugs, generics can either be approved via the centralized procedure (CP: Centralized Procedure ; applies in all EEA countries and is only possible for generics with special approval from the European Medicines Agency ), via the decentralized or mutual recognition procedure (DCP / MRP Decentralized Procedure / Mutual Recognition Procedure ; applies optionally in several countries of the EEA) or obtained marketing authorization via a national approval procedure (only applies in one country at a time). The share of authorization applications for generics in the total application volume in the human pharmaceutical sector is considerable: for the decentralized procedures, it leveled off at around 70% in 2018 compared to 40% in 2000 and 80% in 2010. Among the central ones that were finally processed from 2009 to 2011 Almost 40% of the approval procedures concerned generics.
In the USA, the proportion of referring drug approvals ( Abbreviated New Drug Applications , ANDA, in German for example: Shortened new drug applications ) clearly predominates in the total volume. Of the more than 700 new approvals granted by the FDA in 2011 , around 85% concerned generics.
Therapeutic use of generic drugs
Generics have a firm place in drug therapy today. Basically, their use is established from a therapeutic point of view. Today, generics are often the most important mainstay in the supply of pharmaceuticals; in Germany in 2008 over 60% of all pharmaceuticals prescribed by statutory health insurance were generics.
Generics are of great importance for developing countries with high HIV infection rates (especially in Africa). While the original preparations are unaffordable for patients in these regions, generic manufacturers from India in particular can offer medicines at affordable prices due to low labor costs.
Nevertheless, any disadvantages of treatment with generics are discussed. The following cases can occur during therapy with generics:
- Adjustment to an active ingredient: If an active ingredient is re-adjusted, any existing differences in bioavailability do not play a role, as the dose of the drug can be selected individually based on effectiveness and tolerability. From a theoretical point of view, there are no differences between the use of an original preparation or a generic.
- Switching from an original product to a generic product: The limits set by the approval authorities for the 90% confidence interval of the quotient of the average values determined for the parameters to be compared for the generic product and the original product are 80–125%. In practice, the deviations are even significantly smaller. In the specialist community, however, there is a debate as to whether such a change is justifiable and sensible for drugs that are prescribed for serious diseases and have a narrow therapeutic range . Examples of such drugs are anticonvulsants , antiarrhythmics or anticoagulants . For active ingredients with a narrow therapeutic range, the approval authorities can therefore also demand a narrower bioequivalence range of 90–111%. The decision is made within the framework of admission; closer limits are currently prescribed for tacrolimus and ciclosporin .
- Switching from one generic to another generic : The comparative study of bioequivalence always relates to the originator product; a comparison with other generic drugs is not carried out. For drugs with a narrow therapeutic range, it is therefore also discussed whether a switch from one (generic) preparation to another is justifiable. For example, switching preparations several times (different generics) during the therapy of epilepsy with topiramate showed more disadvantages than simply switching preparations.
Substitute drugs have a significant economic impact in emerging countries (including pharmerging markets ), above all in the BRIC countries of China ( Tier 1 ), Brazil, India and Russia (Tier 2). Generics there cover up to 80% of the pharmaceutical market. India is the largest generic drug manufacturer in the world and will continue to grow in the field along with the other states. Some reasons are that an increasing population in emerging markets can afford the drugs and governments continue to try to control the costs.
Brazil has had double-digit growth in pharmaceuticals since 2005. In 2011 growth was 19% and sales climbed to $ 26 billion. According to estimates, Brazil will be the third largest generic drug market in the world in 2015 after the US and China. At the moment, around 80% of total drug costs are borne by consumers and 60% of total health care expenditure is borne by the state. The share of generics was around 5.7% in 2002 and increased to 24% of all drugs sold in 2012. According to the director of the Farmácia Popular program, this was due to a government advertising campaign in 1999. The Brazilian state also maintains a health program called Sistema Único de Saúde , or SUS for short, which in 2012 made over 25 different medicines available free of charge.
In South Africa, the generics company Aspen Pharmacare is benefiting from a trend that private and state health insurance companies only cover the costs of generics.
Another reason for the sustained growth of generic drug manufacturers is the constant expiry of patents on branded drugs. In 2012, it is estimated that patents with a sales volume of $ 37 billion will expire.
|Share of sales attributable to generics in the pharmaceutical market (based on manufacturer selling price ) according to EFPIA (2017)|
Market figures in Europe from July 2007 show that the market penetration with generics varies greatly between the EU member states. Market shares (in terms of sales) range from under 20% in Belgium, Finland, France, Greece, Ireland, Italy and Spain to 20 to 40% in Austria, Denmark, Germany, the Netherlands, Portugal, Sweden, Hungary and the United States Kingdom (UK) up to over 40% in Poland. Political influence plays a role here, especially where the prescription of drugs under the drug name is promoted, such as B. UK. The market share of generics is significantly higher in those new EU member states which historically have only protected intellectual property at a low level.
A study initiated by the EU Commission in 2008 into conditions that might distort competition in the pharmaceutical sector revealed that consumers have to wait an average of up to seven months for generics to be launched after the protection periods have expired. The Commission pledged its support to the regulatory authorities in speeding up the approval process and reviewing the legal framework for pricing, and called on the member states to support the rapid market introduction of generic drugs and promote price competition. The measures are intended to ensure that patients in the EU receive affordable medicines and to strengthen the competitiveness of the pharmaceutical industry.
In Germany, the share of generics in the generic market, i.e. the market for drugs that are no longer protected by patents, has risen continuously. Whereas the proportion of prescriptions for generics among those with statutory health insurance was around 30% in the early 1980s, it reached around 75% in 2002 and around 85% in 2008. If you take all drugs as a basis, the proportion of prescriptions for generics in 2008 was around 62%. These are high figures on a global scale.
According to calculations by the German manufacturer association Pro Generika e. V. is said to have saved 11 billion euros in statutory health insurance through the use of generics in 2008. In Germany, privately insured persons receive proportionally fewer generics and more original preparations. The proportion of prescriptions in the generic market for private patients is around 46.4%.
Generics were enshrined in federal law 98-417 Drug Price Competition and Patent Term Restoration Act (also known as the Hatch-Waxman Act ) in 1984 . Like other drugs, generics must be approved by the Food and Drug Administration ( FDA for short ). The FDA provides the Orange Book an online searchable drug reference with all approved medications available.
The share of generics in prescriptions was initially (i.e. 1984) 19% and in 2007 it was already 63%. According to the market research institute IMS Health , sales of branded drugs on the US market in 2007 were 228 billion US dollars, with generics sales of 58.5 billion US dollars (both figures provisional). Generics thus represented approximately 20.5% of total US sales. In relation to the market share of prescription drugs (short form: Rx or ℞ ), generics made up the largest share at around 66.9%.
The US leads the generic market worldwide.
|rank||country||Generic market value
(in billion US dollars)
|Generics as a percentage of
the total pharmaceutical market
|Generics market share among
|1.||United States||31.7||11.0 1||44.6 2|
|2.||Germany||5.7||17.0 1||40 3|
|3.||Great Britain||4.5||21.7 1||47 2|
|10.||Canada||1.9||15.0 1||40 1|
|Notes: 1 1997, 2 1998, 3 1988, 4 1996|
Countries with high generic market penetration
In 2000, the following countries had the highest shares of generic sales in the pharmaceutical market: Bangladesh (70.9%), Dominican Republic (63.0%), Uruguay (61.5%), South Korea (58.7%) and Argentina (58.6%).
Manufacturers and associations
The manufacturers of innovative, research-intensive drugs and generics usually form two sharply separated groups within the same industry, since the research-based pharmaceutical companies only see the generics producers as beneficiaries, who collect the fruits of their own work without research and sell them at competitive prices Press market. Conversely, the generics manufacturers take the position that the manufacturers of the original preparations will still demand the high prices of their products even after the research costs have long been amortized, which puts an undue financial burden on the health system and the cost bearers. Critics also note that marketing spending outweighs pharmaceutical companies' research spending. However, more and more research-based pharmaceutical companies are also producing generics themselves. For example, the Novartis subsidiary Sandoz , headquartered in Holzkirchen, is the second largest generics company in the world. Generic manufacturers themselves often have subsidiaries that offer the same product even more cheaply (e.g. AbZ Pharma belongs to Ratiopharm and 1A-Pharma to Hexal , which in turn belongs to Novartis ).
Well-known manufacturers of generics in Germany are Ratiopharm, Hexal and Stada . These manufacturers are suppliers of extensive product ranges for different indications. A study from June 2005, which Accenture GmbH carried out in cooperation with the University of Applied Sciences Ingolstadt, provides information about the importance of the generics industry for health care in Germany.
The Association Pro Generika is the most important association of the generics industry in Germany. Its 17 members cover a market share of a good 90 percent of manufacturers who expressly operate as generics companies. The German Generics Association , founded in 1986, announced its dissolution at the end of 2012. He primarily represented the interests of small and medium-sized generics manufacturers in Germany and advocated competition from as many competitors as possible. The generics industry in Austria is represented by the Austrian Generics Association (ÖGV) and in Switzerland by Intergenerika .
In the USA, the generic manufacturers are organized in the Generic Pharmaceutical Association (GPhA).
|2.||Sandoz (Generics Division of Novartis )||Switzerland||9,850|
|7th||Hikma Pharmaceuticals||United Kingdom||1,800|
|9.||Dr. Reddy's Laboratories||India||1,740|
Generic use for ethical reasons
People who are vegetarian or even vegan sometimes use generics not only primarily because of the more favorable conditions, but also for reasons of animal welfare. However, it should always be noted that the active ingredient of each generic was originally tested on animals, which also includes alternative medicine, including phytopharmaceuticals or any traditional medicine in general. Furthermore, as mentioned above, many manufacturers who specialize in generics are subsidiaries of larger pharmaceutical groups - which are primarily research-oriented.
For the latter reason in particular, the use of generic pharmaceuticals does not necessarily mean a countermeasure to empirical animal studies. As a logical consequence, some vegetarians or vegans only resort to medication in emergencies, or even do without them completely.
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