Generics vs. original preparations: a comprehensive comparative analysis

The decision as to whether to generics or original preparations Many people are concerned by the choice of which to buy and this has far-reaching implications for healthcare. More and more people are asking themselves whether the cheaper generics offer the same effectiveness as the more expensive original medication.

Generics are copycat products that are available after the expiry of patent protection for original preparations are manufactured after the expiry of patent protection for original preparations. In contrast original preparations are the first developed by a manufacturer drugsmarketed under the brand name.

In this article, we comprehensively compare the differences between generics and original preparationshighlight important aspects such as patent protection, legal regulations, bioequivalence and cost-effectiveness, as well as the challenges that patients face when switching to originator products. generics face when switching to generics.

H1 Generics vs. original preparations

Generics are copycat products that are manufactured after the patent protection of an original preparation has expired. They are often cheaper, as the research costs of the original preparations are already covered. In comparison original preparations can be up to 20 times more expensive.

Patent protection protects original preparations from competition for a certain period of time. This allows manufacturers to recoup their research costs. With the expiry of the patent generics can come onto the market, which often leads to falling prices. Several companies then offer similar products at competitive prices.

Properties of generics:

Same bioavailability and efficacy as the original
Strict tests before approval
Lower prices

Generics must undergo strict tests before they are approved for the market. These ensure that generics have the same bioavailability and efficacy as the original preparation.

With the use of generics prescription-only medicines more affordable for consumers and health insurers. The price is a significant difference, while the effect remains the same.

Definition of generics

Generics are imitation products of original medicines. They contain the same active ingredient, active ingredient content and the same dosage form. In order to be approved for the market generics must demonstrate the same quality, safety and efficacy as the original drug. Although they differ in name and price, they are generics are generally cheaper. This is because the research and marketing costs of the original drug are no longer incurred. Generics are tested just as rigorously by regulatory authorities as original products in order to guarantee their safety and efficacy.

Definition of originator products

Original preparations are Medicinal products with newly developed active ingredients. They are produced and marketed exclusively by the patent holder during the patent protection period. Patent protection gives the manufacturer the sole right to produce the drug, which prevents competition from generics competition. Original preparations are characterized by their specific composition, which is tailored to a particular therapeutic application. After expiry of the patent, other companies may generics produce generics. These may differ in excipients or formulations. Prices for original preparations are usually higher than those of genericswhich are often only a fraction of the cost.

Differences in patent protection

The patent protection for pharmaceuticals offers companies exclusive manufacturing and marketing rights for 20 years. During this time, several patents can often exist for a single drug. A company usually only benefits from exclusive marketing rights for around 10 years, as the approval of a new active ingredient often takes a whole decade. After the patent protection expires, other companies may genericsi.e. copycat products. These are usually offered at lower prices. In the European Union generics can be launched at the earliest eight years after approval of the original product. Overall, market access for generics is then ten years. Patent protection can be extended by six months if the medicine for children is approved. With additional application studies, protection is increased to up to eleven years.

How patents influence prices

Patents give companies exclusive rights, active ingredients to produce active ingredients. Without competition, prices are higher. After a patent expires generics come onto the market, which leads to price competition and reduces costs. Generic manufacturers forego expensive research and clinical trials, which makes their products cheaper. Several generic manufacturers also increase price pressure. Generics only require bioequivalence testing, which further reduces their approval costs.

Expiry of patent protection

Patent protection for new medicines usually lasts 20 years. During this time, the pharmaceutical company has the sole right to sell its product. After expiry, other manufacturers can generics with the same active ingredient. The effective duration of an economic benefit from a patent is often reduced to 10 to 15 years due to long development and approval times. Special steps, such as pediatric studies, can be taken to extend patent protection. Once patent protection has expired, the research results must be published so that others can produce the corresponding generic drug.

Aspect	Original preparation	Generic drug
Manufacturing costs	High (incl. research)	Low (without research)
Admission costs	High (clinical studies)	Low (bioequivalence tests)
Price	Higher	Lower
Exclusivity	Up to 20 years	After patent expiry

Legal regulations for generics

Requirements for authorization

In Germany generics simplified authorization requirements. Manufacturers can refer to the documents of the original preparations which simplifies the process. Nevertheless, generic manufacturers must prove that their product has the same bioavailability as the original preparation. This proof is provided by scientific studies. The studies show that generics and original medicines are interchangeable. Competent authorities examine Generics according to strict criteria for efficacy, safety and quality before approval. The production processes and their control are subject to the same requirements as for other medicinal products.

Market entry and competitive conditions

The association Pro Generics is the main representative of the generics industry in Germany and represents over 90 percent of generics manufacturers. Competition in the market leads to intensive research, especially in countries with a high proportion of generics. This pressure to innovate contributes to the development of new medicines contribute. Generics contain the same active ingredients and dosages as their reference medicines. There are often differences in excipients, packaging, color, shape, size and dosage. taste. Market access for generics is made possible by the expiry of patent protection for medicines. Without generics the healthcare system would be financially burdened, which underlines the importance of competition in the pharmaceutical market.

Authorization requirements

In Germany, simplified admission requirements apply for genericsas they can fall back on the original manufacturer's existing documentation. Nevertheless, generics manufacturers must prove that their product has the same bioavailability as the original preparation.

Authorization requirements for generics:

Bioavailability: Generics must have the same effect and speed of absorption as the original.
InterchangeabilityScientific studies must prove interchangeability with the original medicinal product.
Efficacy, safety and quality: The tests by the authorities strongly emphasize these aspects.
Production standards: The production processes are subject to strict German and European regulations.

[Table: Comparison of approval requirements]

Admission requirement	Generics	Original preparations
Reference to documents	Yes, use of existing data	No, own studies necessary
Bioavailability	Must be equal to the original	Proven by own studies
Interchangeability	Must be scientifically proven	Original, therefore not relevant
Test method	Strict criteria for quality and safety	Extensive initial testing

The approval of generics is only granted after strict testing and compliance with all regulations. These ensure safe and effective substitution by generics.

Bioequivalence and therapeutic equivalence

For prescribed medicines, it is important that generics have the same efficacy as original preparations as original preparations. This is ensured by bioequivalence studies. These studies show that the generic drug delivers the active ingredient into the bloodstream as quickly and in the same quantity as the originator product. The limits for bioequivalence set by the regulatory authorities normally vary between 80 and 125%. For drugs with a narrow therapeutic range, the requirements are stricter, with a range of 90 to 111%.

Importance of bioequivalence

Bioequivalence is critical to the safety and efficacy of a generic drug. Manufacturers of generics must conduct studies with approximately 24 to 36 healthy participants to demonstrate therapeutic equivalence. The standards for bioequivalence are set by the FDA and vary depending on the dosage form of the drug. Typically, a deviation of about five percent is acceptable. However, for drugs where speed of action is critical, the limits must be stricter.

Comparison of efficacy

Generic drugs contain the same active ingredients like original preparations and achieve the same effect. However, they are on average 30 percent cheaper. The absorption rate of the active ingredient must be between 80 and 125% of the original. Both generics as well as original preparations are subject to the same strict requirements of the Therapeutic Products Agency. In Germany, the effectiveness of generics clear: over 85 percent of the prescribed medicines are generics. Nevertheless, in the case of serious illnesses, the question of whether it makes sense to switch from the original preparation to a generic drug remains an important issue.

These points illustrate the role of bioequivalence and the performance of generics compared to original preparations in modern medicine.

Cost efficiency of generics

Generics offer a cost-effective alternative to original preparations. Since the development and research costs for new active ingredients are eliminated, the generics can be offered at significantly lower prices. As a rule, they only cost around a third of the price of original preparations. This leads to considerable savings for patients. The approval of generics is also more cost-effective, as only bioequivalence tests are required, which are less costly. In addition, competition between generic manufacturers further reduces prices. For patients, the use of generics also means a lower co-payment of 10 percent, in contrast to 40 percent for original medicines.

Price differences between generics and originals

Generic medicines are usually cheaper than their originals. This is because the manufacturers do not have to bear high research and development costs, as the patent protection of the original drug has expired. A comparison shows that original preparations for rheumatism can be up to 20 times more expensive than their generics. medicines against diabetes can cost up to 18 times more. On average generics 30 % cheaper, in some cases even up to 70 % cheaper. Statutory health insurance companies have been using discount agreements since 2007. These oblige pharmacies, reasonably priced generics instead of expensive original preparations instead of expensive original preparations. In this way, healthcare costs can be reduced and the supply of medicines remains affordable.

Savings in the healthcare system

Generics are cost-efficient and help to reduce the burden on the healthcare system. Although they account for less than ten percent of pharmaceutical expenditure, they cover around 75 percent of the pharmaceutical requirements of the statutory health insurance system. health insurance funds. Doctorswho work on generics help to save money - for the health insurance companies and the entire system. In 2008, the use of generics led to savings of 11 billion euros. The aut-idem regulation supports this by enabling the prescription of cost-effective alternatives. In this way generics not only promote savings, but also access to modern therapies for the insured.

Challenges when switching to generics

Switching from original medicines to generics can present a number of challenges. One of the biggest factors is the potential for confusion if the generic product is not clearly labeled. Especially older medicinesthat came on the market before the Federal Food, Drug, and Cosmetic Act of 1938 have no standards for comparison. Therefore, a change is often not advisable.

Another problem is the excipients in genericswhich, although the active ingredient is identical intolerances such as lactose intolerance can cause health problems. The differences in color, shape and size of generics compared to original preparations can irritate patients. This can increase the risk of confusion, especially if several medicines are taken at the same time. Interestingly generics are often twice as expensive in Switzerland as in other European countries. This is due to stricter approval requirements and the need to offer packaging in several languages.

Patient questions and concerns

Many patients worry whether generics have the same efficacy as original preparations as originator products. These concerns primarily relate to the safety of the prescription-only medicines. Since 2001, pharmacists in Switzerland have been allowed to medicines through generics unless the original is expressly requested.

The conversion to generics can lead to confusion, especially for patients with several medications. Different prices and dosage forms Carry contribute to this. In addition, some patients report negative side effectssuch as abdominal cramps and diarrheaafter the switch to generics such as Mephadolor. These reports raise concerns about tolerability. Many patients find it difficult to distinguish between originals and generics as the appearance and name often do not provide clear indications.

Tips for switching

When changing from original preparations to generics it is advisable to seek the advice of a trusted doctor or pharmacist. They can help to clarify any uncertainties. Before switching to a larger quantity of a generic, try a small pack first to test tolerance.

If several medications have to be changed, only change one medication at a time. This makes it easier to understand how the body reacts to the change. To avoid confusion, you should not switch between different medications. generics and use the medicines always buy them at the same place if possible. Keep a list of the medicines you have taken. medicationso that you can show them to your doctor or pharmacist if necessary.

These measures should help to make the switch to generics easier and safer.

Role of manufacturers and approval procedures

Manufacturers of medicinal products play an important role in the introduction of new medicines on the market. Original preparations are protected by patents, meaning that the original manufacturer has the sole right to manufacture them. Only after the patent has expired may generics be produced and sold. These are usually cheaper, as the research costs for new active ingredients are eliminated. The approval of generics must be granted by state authorities to ensure quality and safety. Manufacturers must submit scientific studies to demonstrate the interchangeability of the generics with the original medicine.

Differences in manufacturer approaches

In Germany, there are several companies that specialize in the manufacture of generics have specialized in the production of generics. Companies such as ratiopharm, Stada and Hexal offer a wide range of active ingredients. Some providers focus on special groups of medicines such as Antibiotics or neurological preparations. Generics require the same quality, safety and efficacy as the original drug. They are usually approved under the non-proprietary name of the active ingredient, but can also bear the trade name of the manufacturer. The production is cheaper, as various manufacturers generics can produce generics. Biopharmaceutical manufacturers must instead offer biosimilars, which are similar but not identical to the original product.

Procedure for the authorization of generics

The authorization of generics in Germany is simplified by the fact that it is based on the original manufacturer's data. Generics require proof of the same bioavailability as the original. This ensures that the effect of the medicine remains the same. The competent authorities carry out strict tests with regard to safety and quality. The same requirements apply as for all other medicines according to German and European standards. The official proof of approval guarantees that generics have the same active ingredient and the same quality as the original.

Comparison	Original preparations	Generics
Price	Higher due to research costs	Lower, as no research costs
Production costs	Only from the patent holder	Several manufacturers possible
Authorization	Complex tests	Easier conditions, reference to original documents
Bioavailability	Proven	Must be equivalent

These aspects and procedures ensure that patients receive both original preparations as well as generics with confidence.

Meaning of generics in patient care

Generics play an important role in drug therapy. In Germany, they accounted for over 60 % of prescription drugs in 2008. medicines that were covered by statutory health insurance. In the USA, they accounted for around 85% of new approvals. These figures show that generics are of great importance in the healthcare sector worldwide.

Advantages of generics:

Costs: Generics are cheaper because they cover the high development costs of the original preparations do not have to bear.
AccessibilityMore Patients can be supplied with proven medications.
Safety and efficacyThey contain known active ingredientswhose safety has been proven by years of clinical studies.

Access to medicines for patients

Generics are crucial for access to essential medicines. Due to their cost-effective production, they are offered at lower prices. In Germany, the proportion of prescribed generics from around 30% in the 1980s to 62% in 2008. The EU Commission is endeavoring to simplify approval procedures for generic drugs. generics to speed up the approval process. Pharmacies can often dispense a generic drug instead of an original preparation if no substitution is excluded on the prescription.

Improving healthcare provision

Generics Carry contribute to significant savings in the healthcare system, which eases the financial burden on the system. They promote competition and drive research, which stimulates the development of new therapies. In Europe, twice the number of patients can be treated at the same cost. Generics also offer faster access to expensive therapies and optimize healthcare as a whole.

Competition in the healthcare market

The healthcare market is experiencing generics a considerable boost to competition. These cheaper alternatives to original preparations enter the market as soon as a drug's patent protection expires. Particularly in countries with a high proportion of generics intensive research activities can be seen. Competition between manufacturers is driving innovation. Pharmaceutical companies that generics save large sums of money as they avoid the expensive research and development costs of the original active ingredients. In Germany, the proportion of generics without patent protection has risen steadily in recent years. In 2008, they accounted for around 62 % of the total market.

Influence of generics on drug prices

Generics are generally significantly cheaper than original products. This makes care affordable and ensures access to necessary therapies for many people. Thanks to the savings made by generics the community of insured persons can also cover expensive drugs finance. Generic manufacturers have to spend less on research and development. This leads to lower costs for the patient. Average costs generics 30 % less than their originals, sometimes they are even up to 70 % cheaper. As soon as patent protection ends, many companies often enter the market with their generics which increases competition and leads to better prices.

Dynamics of competition between manufacturers

Competition between generic manufacturers is particularly intense, as several companies enter the market once the patent protection of an original preparation has expired. This leads to competitive prices. We observe strong research activities in countries with a high proportion of generics. Pro Genericsthe German industry association, represents 17 members who account for more than 90 % of the market. This supports competition and offers patients wider access to medicines, while reducing healthcare costs. Thanks to the possibility of obtaining generic products from many manufacturers, the generics remain an efficient and affordable solution.

Conclusion: When are generics the better choice?

Generics offer a cost-effective alternative to original preparations. They are generally at least 30 percent cheaper. This leads to considerable cost savings in the healthcare system. Generics are only approved if they are proven to be bioequivalent to the original medication. This guarantees their effectiveness. These medicines benefit from the research and development work that has already been carried out. As a result, their production costs are much lower.

Generics facilitate access to therapy optionsas they enable greater availability of medicines at affordable prices. They also often offer practical advantages. Many generic medicines have easily divisible tablets or special pack sizes that make it easier for patients to use.