Generic

from Wikipedia, the free encyclopedia

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 ).

costs

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 .

example

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.

The implementation of clinical studies by generic companies is not affected by patent protection (trial privilege ; Roche-Bolar regulation ).

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

Proportion of referring applications in completed authorization procedures for human medicinal products in accordance with Directive 2001/83 / EC and Regulation (EC) No. 726/2004
Decentralized procedures
(MRP + DCP)		 Central
procedures
year Total Generics Total Generics Biosimilars
2018 1.314 923 84 23 9
2017 1,515 1,086 90 15th 17th
2016 1,382 989 114 31 12
2015 1,346 985 111 37 12
2014 1,046 687 100 37 3
2013 1,259 933 80 12 1
2012 1,464 1,148 96 21st 8th
2011 1,640 1,285 91 34 0
2010 1,777 1,439 54 20th 1
2009 1,682 1,343 125 51 0
2008 1,145 912 72 4th 6th
2007 833 641 65 5 5
2006 592 419
2005 954 613
2004 760 495
2003 529 319
2002 420 226
2001 443 226
2000 306 124

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.

Economical meaning

Emerging markets

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.

European countries

Share of sales attributable to generics in the pharmaceutical market (based on manufacturer selling price ) according to EFPIA (2017)
Belgium 2
  
 16.6%
Bulgaria 1
  
 48.0%
Denmark 1
  
 31.1%
Germany 2
  
 31.2%
Estonia 1
  
 19.2%
Finland 1
  
 26.0%
France 2.4
  
 19.2%
Greece 1
  
 22.5%
Ireland 1
  
 15.8%
Italy 2
  
 59.0%
Croatia 1
  
 43.0%
Lithuania 3
  
 26.0%
Netherlands 2
  
 18.4%
Norway 3
  
 20.3%
Austria 2
  
 40.3%
Poland 3
  
 52.9%
Portugal 2
  
 22.6%
Romania 3
  
 28.0%
Russia 3
  
 57.0%
Sweden 3
  
 20.2%
Switzerland 3
  
 13.6%
Serbia 3
  
 38.0%
Slovakia 3
  
 19.7%
Slovenia 2
  
 25.1%
Spain 2
  
 21.9%
UK 1.5
  
 27.0%
Hungary 1
  
 37.6%
1  proportionally in the pharmacy market; 2  proportionally in the pharmacy market, only reimbursable drugs taken into account; 3 in  proportion to the total market; 4  only takes officially listed medicinal substances into account; 5  based on NHS reimbursement prices

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%.

United States

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.

Leading generic markets in 2000
by sales
rank country Generic market value
(in billion US dollars) 		Generics as a percentage of
the total pharmaceutical market
(in%) 		Generics market share among
prescribed drugs
(in%)
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
4th France 4.4 2.0 3.0 4
5. Italy 3.0 27.9
6th Brazil 2.4 47.5
7th Spain 2.2 31.2
8th. Argentina 2.0 58.6
9. Mexico 2.0 40.0
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).

Largest generics manufacturers in the world in 2018,
by revenue in million US dollars
rank Companies Head office sales
1. Mylan United States 000000000011260.000000000011,260
2. Sandoz (Generics Division of Novartis ) Switzerland 000000000009850.00000000009,850
3. Teva Israel 000000000009670.00000000009,670
4th Sun Pharmaceutical India 000000000004110.00000000004.110
5. Lupine India 000000000002270.00000000002,270
6th Cipla India 000000000002200.00000000002,200
7th Hikma Pharmaceuticals United Kingdom 000000000001800.00000000001,800
8th. Sawai Pharmaceutical Japan 000000000001770.00000000001,770
9. Dr. Reddy's Laboratories India 000000000001740.00000000001,740
10. Sanofi France 000000000001690.00000000001,690

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.

See also

Web links

Wiktionary: Generic  - explanations of meanings, word origins, synonyms, translations

Individual evidence

  1. ↑ Art. 10 para. 2 letter b Directive 2001/83 / EC ; Section 24b (2) AMG (DE); § 1 Paragraph 19 AMG (AT); Art. 4 para. 1 letter a septies HMG (CH)
  2. ↑ Art. 10 Directive 2001/83 / EC ; § 24b AMG (DE); § 10 AMG (AT); Art. 12 TPA (CH)
  3. ↑ Christoph Baumgärtel: Generics - An update . In: Austrian Pharmacists Association, Association of Employed Pharmacists Austria (Ed.): Österreichische Apotheker-Zeitung . tape 65 , no. 9 . Österreichische Apotheker-Verlagsgesellschaft mb H., Vienna April 26, 2011, p. 46–49 ( apoverlag.at [PDF; 12.2 MB ; accessed on May 3, 2011]).
  4. ↑ a b Patrick E. Nwakama, Sam H. Haidar, u. a .: Generic Drug Products Demonstrate Small Differences in Bioavailability Relative to the Brand Name Counterparts: A Review of ANDAs Approved 1996-2005. In: 12th Annual FDA Science Forum. Center for Drug Evaluation and Research, Food and Drug Administration , April 2006, archived from the original on March 4, 2016 ; Retrieved on December 25, 2012 (English): "The mean (± SD) of the absolute value of the difference in point estimates | T - R | for AUC0-T was 3.19% (± 2.72) and 3.12% (± 2.66) for AUC0-inf. Mean difference for Cmax was 4.50% (± 3.57). "
  5. ↑ Parade of the inexpensive. In: test 10/2004. Stiftung Warentest , pp. 91–95 , accessed on February 4, 2019 .
  6. ↑ Timo Stukenberg: Medicines - health insurance companies could save two billion euros. In: SPIEGEL ONLINE . August 20, 2014, accessed August 28, 2019 .
  7. ↑ Generics. In: Lexicon. AOK Federal Association, accessed on August 28, 2019 .
  8. ↑ Regulation (EEC) No. 1768/92 of the Council of June 18, 1992 on the creation of a supplementary protection certificate for medicinal products in the consolidated version of July 2, 1992 (PDF; 641 kB), accessed on February 4, 2019 see recitals and Article 13.
  9. ↑ Regulation (EC) No. 1901/2006 : Article 36.
  10. ↑ Directive 2001/83 / EC : Article 10 (1).
  11. ↑ § 11 Patent Act (Germany) .
  12. ↑ EU wants to facilitate the production and export of generics and biosimilars , Ärzteblatt from February 18, 2019, accessed February 23, 2019
  13. ↑ Statistics on non-central approval procedures of the Heads of Medicines Agencies
  14. ^ Statistics on central procedures of the European Medicines Agency .
  15. ↑ a b Note for Guidance on the Investigation of Bioavailability and Bioequivalence. (99KB PDF) In: The European Agency for the Evaluation of Medicinal Products. Committee for Proprietary Medicinal Products, July 26, 2001, archived from the original on February 21, 2007 ; accessed on December 29, 2012 .
  16. ^ A b Guideline on the Investigation of Bioequivalence. (233 kB; PDF) European Medicines Agency, Committee for Medicinal Products for Human Use, January 20, 2010, accessed on August 10, 2010 (English).
  17. ↑ Guidance for Industry. Statistical Approaches to Establishing Bioequivalence. (130KB PDF) In: US Department of Health and Human Services. Food and Drug Administration , Center for Drug Evaluation and Research, January 2001, accessed December 29, 2012 .
  18. ↑ Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. (394KB PDF) In: US Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research, March 2003, accessed December 29, 2012 .
  19. ↑ bioequivalence Recommendations for Specific Products. In: US Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research, December 20, 2012, accessed December 29, 2012 .
  20. ^ Drugs @ FDA: Drug Approval Reports .
  21. ↑ Swiss Radio DRS; Article in Echo der Zeit , April 28, 2010.
  22. ↑ BJ Steinhoff, U. Runge, OW Witte et al .: Substitution of anticonvulsant drugs. In: Ther Clin Risk Manag. , 2009, 5, pp. 449–457, PMID 19707254 , PMC 2701486 (free full text)
  23. ↑ MJ Berg, RA Gross, KJ Tomaszewski et al. Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures. In: Neurology , 2008, 71, pp. 525-530, PMID 18695164 .
  24. ↑ JA Reiffel, PR Kowey: Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias. In: Am J Cardiol. , 2000, 85, pp. 1151-1153, PMID 10781771 .
  25. ↑ AS Kesselheim, AS Misono, JL Lee et al .: Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. In: J Am Med Ass. , 2008, 300, pp. 2514-2526. doi: 10.1001 / jama.2008.758 PMID 19050195 .
  26. ↑ Christoph Baumgärtel: Bioequivalence - Medicines with a narrow therapeutic range . In: Austrian Pharmacists Association, Association of Employed Pharmacists Austria (Ed.): Österreichische Apotheker-Zeitung . tape 66 , no. 23 . Österreichische Apotheker-Verlagsgesellschaft, Vienna November 5, 2012, p. 60–61 ( apoverlag.at [PDF; accessed on April 11, 2013]).
  27. ↑ Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party. (PDF; 300 kB) European Medicines Agency , Committee for Human Medicinal Products , Pharmacokinetics Working Party (PKWP), December 10, 2012, accessed on December 25, 2012 (English).
  28. ↑ MS Duh, PE Paradis, D. Latrémouille-Viau et al. The risks and costs of multiple-generic substitution of topiramate. In: Neurology , 2009, 72, pp. 2122-2129, PMID 19528520 .
  29. ^ IMS Institute for Healthcare Informatics: The Global Use of Medicines. (2,653KB PDF) Outlook Through 2015. May 16, 2011, accessed on January 10, 2012 .
  30. ^ A b German Health News: 2012: Good year for generic manufacturers. August 31, 2012, accessed December 29, 2012 .
  31. ↑ Boehringer Ingelheim: Medicines are often privately financed - the pharmaceutical market is growing rapidly. (No longer available online.) 2012, archived from the original on July 31, 2013 ; Retrieved December 29, 2012 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / www.boehringer-ingelheim.de
  32. ↑ # portal.saude.gov.br ( Memento of the original from January 16, 2013 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / portal.saude.gov.br
  33. ↑ BrasilNews: Brazil: Share of generics quadrupled in the last decade. August 10, 2012, accessed December 29, 2012 .
  34. ↑ a b The Pharmaceutical Industry in Figures, 2019 (PDF; 3.9 MB), page 17.
  35. ^ Pharmaceutical Sector Inquiry Final Report. (PDF; 2.7 MB), adopted July 8, 2009, p. 61.
  36. ↑ Summary of the report on the pharmaceutical sector inquiry. (PDF; 144 kB), Communication from the Commission of July 8, 2009.
  37. ↑ The pharmaceutical market of the statutory health insurance in 2008. (PDF; 71 kB) (No longer available online.) In: Press releases 2009. Pro Generika e. V., February 12, 2009, archived from the original on August 10, 2013 ; Retrieved July 9, 2009 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / www.progenerika.de
  38. ↑ F. Wild: The importance of generics in private health insurance in 2007 ( Memento of the original from April 24, 2009 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. (PDF; 145 kB). September 8, 2009. @1@ 2Template: Webachiv / IABot / www.wip-pkv.de
  39. ↑ codified in particular as 21 USC § 355 (j) Abbreviated new drug applications
  40. ^ Food and Drug Administration - Center for Drug Evaluation and Research: Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations .
  41. ↑ a b Annual Report 2008. (PDF) Generics: The Right Choice for Better Health. The Generic Pharmaceutical Association, February 7, 2008, accessed December 28, 2012 .
  42. ^ A b World Health Organization: The World Medicines Situation. (1,052KB PDF) September 8, 2004, accessed December 31, 2012 (English).
  43. ^ Accenture Health & Life Sciences. The importance of the generics industry for health care in Germany ( Memento of the original from October 2, 2008 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. . June 2005. @1@ 2Template: Webachiv / IABot / www.progenerika.de
  44. ↑ Member companies of the Pro Generika Association , December 5, 2013.
  45. ^ Apotheke-aktuell: The German Generic Association e. V. will be dissolved ( Memento of the original from July 31, 2013 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , accessed December 29, 2012. @1@ 2Template: Webachiv / IABot / www.apotheke-aktuell.com
  46. ↑ Revenue of leading generics manufacturers worldwide in 2018 (in billion US dollars). In: statista.com. 2018, accessed November 15, 2019 .
  47. ^ Kilian thirty: Medicines against colds and fever. Retrieved April 4, 2020 .
  48. ↑ FAQ - Questions and Answers. Retrieved April 4, 2020 .