Generics contain the same active ingredient as the original drugs and are available after their patent has expired. They are bioequivalent, meaning they provide the same therapeutic effect as the so-called originals. Generics meet strict regulatory standards as regards quality, safety and efficacy and are usually cheaper, as their manufacturers do not have to pay to research and develop a new active ingredient. Generics make treatment more available and reduce healthcare costs.

Yes, generics are just as effective as their originator pharmaceuticals because they contain the same active ingredient, in the same amount and in the same dosage form. They must demonstrate bioequivalence, meaning that they act in the body in the same way as the originator pharmaceuticals. Regulatory authorities such as the European Medicines Agency (EMA) within EU Member States and individual national regulatory authorities require and check that generics meet strict quality, safety and efficacy standards. Although they may contain different excipients, these differences usually have no significant impact on the therapeutic effect. Patients usually do not notice any differences in efficacy between generic and originator drugs.

They are generally cheaper because their manufacturers do not have to pay the costs of researching and developing a new active ingredient or conducting extensive clinical trials. The marketing and promotion costs are also usually lower for generics. Regulatory authorities already have the necessary data on the safety and efficacy of the active ingredient from the originator, which further reduces the cost of approving the generic.

Generics contain the same active ingredient as the original drugs; the active ingredient is the only substance that has the therapeutic effect and is therefore identical in the generic and the originator. However, generics do not necessarily contain the same excipients as the originators. Excipients are non-active ingredients that may include binders, fillers, colorants, preservatives, and other additives used to create the final form of the drug.

While the active ingredients in generics are the same as in the originator pharmaceuticals, excipients may cause small differences in effect. However, the majority of patients will not notice any differences. If you have concerns or problems with a generic drug, it is important to consult a healthcare professional.

Generics have to go through an approval process involving several stages before they can be marketed. The manufacturer submits an application to the national regulatory authorities or the EMA, which includes evidence of bioequivalence, meaning that the generic acts in the body in the same way as the originator. It must also meet strict quality, safety and efficacy standards that are the same for all pharmaceuticals, including originators. The regulatory authorities examine manufacturing processes and check that the drug is free of harmful substances and stable throughout its shelf life. If a generic meets all the requirements, it is approved for sale.

A generic can appear on the market after the patent protection of the originator pharmaceutical has expired, which is usually 20 years from the date the patent application was filed, and at the same time until at least 10 years have passed since the originator was first registered/approved in the EU. Before the expiry of the protection periods (patent and registration), generic manufacturers can apply for regulatory approval of their versions of the drug, which can take several months to years. The process involves demonstrating bioequivalence and compliance with all the regulatory requirements. In some cases, multiple generic versions may be launched simultaneously, increasing competition and lowering prices. The total time from when the originator pharmaceutical is launched until the generic becomes available therefore depends on the length of the patent and the speed of the approval process.

Generic competition significantly reduces the price of drugs on the market as more manufacturers offer equivalent products. This increases the availability of treatment for patients, who have access to more affordable drugs. The reduction in the prices of generic also puts pressure on the manufacturers of originator pharmaceuticals to innovate and develop new drugs. This competition ensures fairer market conditions and promotes economic efficiency in the healthcare system. Overall, it plays a part in improving public health by giving more people access to the treatment they need.