Biosimilar medicines, also known as biosimilars, are used in medicine to treat severe and chronic conditions such as cancer, diabetes and autoimmune diseases. Biosimilars – true to their name, they are similar to existing biological reference drugs. They are produced using living organisms or their cells, such as proteins, antibodies and other biological substances. These pharmaceuticals are also produced using biological processes but are not identical to the original reference medicines.
Biosimilars must meet certain criteria to be approved by the relevant regulatory authorities. They must be similar in quality, efficacy and safety to reference medicines. This means that they must have similar biological properties, such as action, mode of action and side effects, to those of the reference drugs.
Molecular farming is a field of biotechnology that promotes the use of plant crops as biofactories for the production of high-value bioproducts using biotechnology. The term also includes the genetic modification of agricultural products for the production of proteins for commercial and pharmaceutical purposes. The transformation of non-viable crops into efficient biofactories is aimed at an effective solution in the context of a modern bioeconomy and at the same time supporting a sustainable rural development strategy through, among others, the best possible synthesis of plants with drugs.
The term “molecular farming” was coined in 1986, but it took three decades for the FDA (Food and Drug Administration) to approve the first plant-derived therapeutic protein. Carrot cell protein turned out to be a valuable tool in the treatment of a rare genetic disorder, which is Gaucher disease, which causes abnormal breakdown of fats in the human body, and therapeutic protein of plant origin helps restore proper metabolic function (research by the Israeli pharmaceutical company Protalix BioTherapeutics has shown this fact). Plant-derived pharmaceutical products have received a lot of attention in recent years due to the increasing demand for clinical applications in recent years.
A drug in a disposable dispenser as a slimming agent – is it legal?
Press controversies related to the use of modern drugs created for the treatment of chronic diseases for procedures with the use of their side effects raise a number of legal problems related to the legality of using such medicinal products for non-dedicated procedures with the use of side effects of the medicinal substance.
Legal assessment on the example of press releases about the use of diabetes drugs, such Ozempic for slimming. Regulatory issues between the drug law and the law of medical devices.
On 5 January 2023 the Corporate Sustainability Reporting Directive (CSRD) entered into force. In the framework of European green deal and ESG initiatives, this new directive tries to modernize and strengthen the rules about social and environmental information that companies have to report. A broader set of large companies, as well as listed SMEs, will now be required to report on sustainability – approximately 50.000 companies in total. By the previous regulation, the Non-Financial Reporting Directive, only about 11.000 companies were required to report. A consultation carried out by the Commission found that many stakeholders were in favour of extending reporting requirements to additional categories of companies.