What are generic drugs?

A generic drug is a medication created to be the same as an originator drug in dosage form, strength, intended use, quality, efficiency, and safety.

Generic medicines use the same active ingredients as the originator medicines and are their equivalent replacement. They may have different characteristics, such as manufacturing process, formulation, excipients, colour, taste, and packaging.

What are the benefits of generic drugs?

Generic drugs have one common purpose: to provide an equally efficient and safe drug, cheaper than the originator drug. Generic drugs are cheaper because they take less time to develop and do not have to repeat the many animal and human studies required of the originator drugs.

Generic drugs are allowed for sale only after the patents on the originator drugs expire.

*One of the main benefits of generic drugs is greater access to drugs for patients during growing demand for health services and limited funds. In the past ten years, generic drugs have increased access to medicines by more than 100% in seven crucial therapeutic areas without increasing the end price of treatment. As a result, millions of patients in Europe have access to high-quality treatment.

67% of all prescription drugs in Europe are generic drugs, carrying only 29% of the total costs.

More statistics on the role of generic drugs in ensuring sustainable health systems in Europe can be found in the infographic below.

Alkaloid’s Generic Drugs

Our professional and highly specialized employees always follow the current requirements and standards when developing generic products. The end goal to create products equally as good, efficient, and safe as the originator drugs, at the same time available and affordable for extended use in the countries of the region and beyond.

Most developed countries require generic manufacturers to prove that their products are bioequivalent to the originator drugs before approval.

What is bioequivalence?

Two drugs are bioequivalent if they contain the same amount of the same active substance, with the same strength, in the same dosage form, and have a proven similar bioavailability. It is thereby expected that generic drugs have the same therapeutic effects and safety profile as originator drugs. Bioequivalence is proven in specially designed clinical studies on volunteer subjects, following defined and approved protocols.

Generic drug manufacturers must also comply with the rules of Current Good Manufacturing Practice (cGMP) required with medicines legislation.

What is the legislation for the manufacturing of generic drugs?

Regulatory agencies require drug manufacturers to maintain appropriate standards for quality of method and quality control, and of facilities for production, packaging, and processing of drugs. Alkaloid produces drugs in compliance with the leading global norms and the highest standards for drug manufacturing required with the European Union GMP. Regular controls performed by competent Macedonian and international inspection services confirm this.

In Alkaloid, we always aim at improving and maintaining each individual's health and continuously invest in creating high-quality generic drugs.

The long-lasting presence of Alkaloid's pharmaceutical portfolio in most of the countries of the region and beyond confirm the quality of its drugs. Its brands are also well established among health professionals and consumers.


The role of generic medicines in sustaining healthcare systems:

A European perspective