A biopharmaceutical (biological or biologic), which consists of sugars, proteins, nucleic acids, living cells, or tissues, is a medicinal product manufactured in extracted or semi-synthesized from biological sources like humans, animals, or microorganisms. Different from traditional drugs synthesized from chemical processes, the majority of biopharmaceutical products are derived from biological processes including the extraction from living systems or the production by recombinant DNA technologies (Table 1). Transgenic organisms, especially plants, animals, or microorganisms that have been genetically modified, are potentially used to produce biopharmaceuticals.

Biopharmaceuticals are revolutionizing the world of medicine and saving the lives of thousands of people every day. Patients suffering from cancer, diabetes, cardiovascular disease, immune diseases, and other health problems already benefit from biopharmaceuticals, which provides targeted treatment and fewer side effects. Soon, billions of people around the world will benefit from this innovative approach to treating disease.

Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms pertaining to different subsets of therapeutics within the overall biopharmaceutical category. Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid-based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source. Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. the ecu Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are “based on genes, cells, or tissue engineering”, including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof. Within EMA contexts, the term advanced therapies refers specifically to ATMPs, although that term is quite nonspecific outside those contexts.

There is an urgent need for new discoveries and development in biodrugs field. Indeed, the continuous development mutations of viruses and microbes and the emergence of distinct types of diseases along with numerous patients with specific cases push the industrial and biopharmaceutical sectors to collaborate with each other to innovate and develop new biodrug to face this dilemma and serve the interest of all mankind healthcares. This would lead to an increase in the lifetime expectancy and an improvement of life quality via providing better therapies. However, the biopharmaceutical innovation faces numerous challenges and difficulties before giving birth to a new biodrug but this did not stop it from discovering and boosting the development and innovation of drugs with huge benefits and better health outcomes for the population. Such development improves the quality of life for the society and the coming generations. Within this review, we describe selected examples that illustrate the benefits of the biopharmaceutical innovation as well as the related challenges.

Regards,

Elsa

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