Cytokines and Growth Factors
A C Silva1,2, J M Sousa Lobo3
1UCIBIO/REQUIMTE, MEDTECH, Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal. ana.silva@ff.up.pt.
Advances in Biochemical Engineering/Biotechnology
|August 7, 2019
Summary
Recombinant cytokines and growth factors are increasingly important in medicine, with many approved for treating diseases like cancer and infections. Future approvals are expected for more biological and biosimilar medicines.
Area of Science:
- Biotechnology
- Immunology
- Pharmacology
Background:
- Cytokines like interferons (IFNs), interleukins (ILs), and tumor necrosis factors (TNFs) are used for autoimmune diseases, infections, cancer, and skin regeneration.
- Hematopoietic growth factors (HGFs) such as epoetin and colony-stimulating factors (CSFs) treat anemia and neutropenia, respectively.
- While many growth factors are explored, few have demonstrated clinical relevance for market approval.
Purpose of the Study:
- To provide an overview of therapeutic applications of biological medicines containing recombinant cytokines and growth factors.
- To review the clinical relevance and regulatory status of approved recombinant cytokine-based therapies.
- To highlight progress in cytokine discovery and future prospects in therapeutic applications.
Main Methods:
- Literature review of therapeutic applications of recombinant cytokines and growth factors.
- Analysis of regulatory approvals by the European Medicines Agency (EMA) and Food and Drug Administration (FDA) since the 1980s.
- Examination of withdrawn, biosimilar, and orphan designations for approved biological medicines.
Main Results:
- The clinical relevance of recombinant cytokines has significantly increased.
- 89 biological medicines containing recombinant cytokines have been approved by EMA/FDA since the 1980s.
- Of the approved medicines, 18 were withdrawn, 24 are biosimilars, and 18 are designated as orphan drugs.
Conclusions:
- Considerable progress has been made in discovering new cytokines and understanding their functions in human diseases.
- The therapeutic landscape for recombinant cytokines and growth factors is expanding.
- Future prospects include the approval of additional biological and biosimilar medicines for diverse therapeutic applications.
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