Biologics and Biosimilars: Advancements, Challenges, and Therapeutic Applications
1Joseph Obiezu Chukwujekwu Ezeonwumelu, 2Uhama Kingsley Chukwuka, 3Ugwu Okechukwu Paul-Chima, 3Alum Esther Ugo, 4Ugwuanyi Anthony Chukwudi and 5Tambwe Patrick Rodrigue
1Department of Clinical Pharmacy and Pharmacy Practice, Kampala International University Western Campus, Uganda.
2Department of Biochemistry, Faculty of Applied Natural Sciences, Enugu State University of Science and Technology, Nigeria.
3Department of Publication and Extension Kampala International University Uganda.
4Department of Microbiology Ebonyi State University Abakaliki, Nigeria.
5Department of Public Health Kampala International University Uganda.
Email: kingsley.uhama@esut.edu.ng
ABSTRACT
Biologics, derived from living cells, have revolutionized the treatment of chronic and complex diseases such as cancer, autoimmune disorders, and metabolic diseases. These complex molecules often exhibit superior efficacy and safety profiles compared to traditional chemical drugs, owing to their unique pharmacologic mechanisms and biophysical properties. The increasing demand for biologics has also spurred the development of biosimilars, cost-effective versions that promise to alleviate the financial burden on healthcare systems. Despite their benefits, biologics and biosimilars face significant manufacturing, regulatory, and economic challenges. This paper explores the definition, characteristics, and therapeutic applications of biologics, alongside the intricate processes involved in their production and purification. It also delves into the regulatory landscape governing biologics and biosimilars, highlighting the approval processes and future directions for innovation and accessibility in this rapidly evolving field.
Keywords: Biologics, Biosimilars, Therapeutic proteins, Monoclonal antibodies, Cytokines and Growth factors
CITE AS: Joseph Obiezu Chukwujekwu Ezeonwumelu, Uhama Kingsley Chukwuka, Ugwu Okechukwu Paul-Chima, Alum Esther Ugo, Ugwuanyi Anthony Chukwudi and Tambwe Patrick Rodrigue (2024). Biologics and Biosimilars: Advancements, Challenges, and Therapeutic Applications. RESEARCH INVENTION JOURNAL OF SCIENTIFIC AND EXPERIMENTAL SCIENCES 3(1):6-11.