What are biopharmaceuticals?

Abstract

Throughout history, biopharmaceuticals have been essential in addressing health crises and enhancing human well-being. With advancements in genetic engineering, biotechnology, and bioinformatics, the development and approval rates of new biopharmaceuticals have surged, placing them at the forefront of the pharmaceutical field. Modern manufacturing processes and streamlined regulatory pathways have further expedited approval timelines, providing hope for previously untreatable conditions and significantly improving patients’ quality of life worldwide. However, despite these advancements, ambiguity persists regarding the definition of biopharmaceuticals due to the use of varied terms and a lack of standardized definitions. This article addresses this confusion by proposing a clear and comprehensive definition of biopharmaceuticals. Additionally, we present a reclassification of biopharmaceuticals into seven distinct verticals based on their functions. We assert that biopharmaceuticals not only offer superior therapeutic benefits for human health but also contribute to environmental sustainability, promoting a healthier planet. Thus, this article aims to clarify the scope of biopharmaceuticals and advocate for their broader adoption in the pursuit of global health and environmental integrity.

Keywords

Biopharmaceuticals / classification / chempharmaceuticals / environmental sustainability

References

[1] Rasmussen ASB, Hammou A, Poulsen TF, Laursen MC, Hansen SF. Definition, categorization, and environmental risk assessment of biopharmaceuticals. Sci Total Environ. 2021; 789: 147884.

[2] Rader RA. What Is a Biopharmaceutical? Part. 2005; 1: 60-5.

[3] Dasani S, Palanki R, Menon P, Bose SK. Biopharmaceuticals. In: Eltorai AEM, Bakal JA, Newell PC, Osband AJ, editors. Translational Surgery. Academic Press; 2023. pp. 535—8.

[4] What Are “Biologics” Questions and Answers [Internet]. U.S. Food & Drug Administration; [cited 2024 Jun 2]. Available from: https://www.fda.gov/about—fda/center—biologics—evaluation—and—research—cber/what—are—biologics—questions—and—answers

[5] Tsang L, Cortez N. Biopharmaceuticals: Definition and regulation. In: Pharmaceutical Sciences Encyclopedia: Drug Discovery, Development, and Manufacturing. John Wiley & Sons, Ltd; 2010. pp. 1-18.

[6] U.S. Code. Social Security—Subchapter XX—Block Grants to States for Social Services and Elder Justice Division B—Elder Justice. In: The Public Health and Welfare. NY: Legal Information Institute, LII; §§ 1397—1397n—13.

[7] Walsh G. Biopharmaceuticals and biotechnology medicines: an issue of nomenclature. Eur J Pharm Sci. 2002; 15: 135—8.

[8] Samanen J. Similarities and differences in the discovery and use of biopharmaceuticals and small—molecule chemotherapeutics. In: Ganellin R, Roberts S, Jefferis R, editors. Introduction to biological and small molecule drug research and development. Elsevier; 2013. pp. 161-203.

[9] Rader RA. (Re)defining biopharmaceutical. Nat Biotechnol. 2008; 26: 743-51.

[10] Small vs Big: Understanding the Differences between Small Molecule Drugs and Biologic Drugs [Internet]. Toronto: IMMpress Magazine; c2019 [cited 2024 Jun 2]. Available from: https://www.immpressmagazine.com/small—vs—big—understanding—the—differences—between—small—molecule—drugs—and—biologic—drugs/

[11] Miettinen M, Khan SA. Pharmaceutical pollution: A weakly regulated global environmental risk. RECIEL. 2022; 31: 75-88.

[12] Moermond CTA, Puhlmann N, Brown AR, Owen SF, Ryan J, Snape J, et al. GREENER Pharmaceuticals for More Sustainable Healthcare. Environ Sci Technol Lett. 2022; 9: 699-705.

[13] Sharma J, Joshi M, Bhatnagar A, Chaurasia AK, Nigam S. Pharmaceutical residues: One of the significant problems in achieving ‘clean water for all’ and its solution. Environ Res. 2022; 215: 114219.

[14] Kümmerer K, Dionysiou DD, Olsson O, Fatta—Kassinos D. A path to clean water. Science. 2018; 361: 222—4.

[15] Green pharma: the growing demand for environmentally friendly drugs [Internet]. London: Verdict Media Limited; c2024 [cited 2024 Jun 4]. Available from: https://www.pharmaceutical—technology.com/comment/commentgreen—pharma—the—growing—demand—for—environmentally—friendly—drugs—5937344/

[16] Tiller KE, Tessier PM. Advances in Antibody Design. Annu Rev Biomed Eng. 2015; 17: 191-216.

[17] Sgro C. Side—effects of a monoclonal antibody, muromonab CD3/orthoclone OKT3: bibliographic review. Toxicology. 1995; 105: 23-9.

[18] Walsh G, Walsh E. Biopharmaceutical benchmarks 2022. Nat Biotechnol. 2022; 40: 1722—60.

[19] Crescioli S, Kaplon H, Chenoweth A, Wang L, Visweswaraiah J, Reichert JM. Antibodies to watch in 2024. MAbs. 2024; 16: 2297450.

[20] Pande AH, Sandeep, Shinde SH. Polybodies: Next—generation clinical antibodies. Drug Discov Today. 2024; 29: 104198.

[21] Lim K, Zhu XS, Zhou D, Ren S, Phipps A. Clinical Pharmacology Strategies for Bispecific Antibody Development: Learnings from FDA—Approved Bispecific Antibodies in Oncology. Clin Pharmacol Ther. 2024; 116: 315-27.

[22] Liu K, Li M, Li Y, Li Y, Chen Z, Tang Y, et al. A review of the clinical efficacy of FDA—approved antibody‒drug conjugates in human cancers. Mol Cancer. 2024; 23: 62.

[23] Monoclonal Antibodies Industry is Rising Rapidly [Internet]. BioSpace; c2024 [cited 2024 Oct 12]. Available from: https://www.biospace.com/article/releases/monoclonal—antibodies—industry—is—rising—rapidly/

[24] Monoclonal Antibodies (MAs) Global Market Report 2024 [Internet]. TBRC The Business Research Private Ltd.; c2024 [cited 2024 Oct 12]. Available from: https://www.thebusinessresearchcompany.com/report/monoclonal—antibodies—global—market—report

[25] Growing Demand for Monoclonal Antibodies to Boost the Cell Culture Market [Internet]. Meticulous Market Research Pvt. Ltd.; c2024 [cited 2024 Oct 12]. Available from: https://www.meticulousresearch.com/blog/127/growing—demand—for—monoclonal—antibodies—to—boost—the—cell—culture—market

[26] 100 Years of Insulin [Internet]. Lilly; c2024 [cited 2024 Jun 4]. Available from: https://www.lilly.com/discovery/100—years—of—insulin

[27] Spiliotis BE. Recombinant human growth hormone in the treatment of Turner syndrome. Ther Clin Risk Manag. 2008; 4: 1177-83.

[28] Gou P, Cheng X, Leng J, Su N. A Real—World Study of Recombinant Human Growth Hormone in the Treatment of Idiopathic Short Stature and Growth Hormone Deficiency. Ther Clin Risk Manag. 2022; 18: 113—24.

[29] Lecka—Ambroziak A, Wysocka—Mincewicz M, Doleżal—Ołtarzewska K, Zygmunt—Górska A, Wędrychowicz A, Żak T, et al. ; On Behalf Of The Polish Coordination Group For rhGH Treatment. Effects of Recombinant Human Growth Hormone Treatment, Depending on the Therapy Start in Different Nutritional Phases in Paediatric Patients with Prader—Willi Syndrome: A Polish Multicentre Study. J Clin Med. 2021; 10: 3176.

[30] Jain M, Singh M. Assisted Reproductive Technology (ART) Techniques. Treasure Island (FL): StatPearls Publishing; 2024.

[31] Hormone Replacement Therapy Market Size [Internet]. Global Market Insights Inc.; c2024 [cited 2024 Jun 4]. Available from: https://www.gminsights.com/industry—analysis/hormone—replacement—therapy—market

[32] Hormone replacement therapy market size, share & industry analysis [Internet]. Fortune Business Insights; c2024 [cited 2024 Jun 7]. Available from: https://www.fortunebusinessinsights.com/hormone—replacement—therapy—hrt—market—102543

[33] de la Torre BG, Albericio F. The Pharmaceutical Industry in 2023: An Analysis of FDA Drug Approvals from the Perspective of Molecules. Molecules. 2024; 29: 585.

[34] Robinson PK. Enzymes: principles and biotechnological applications. Essays Biochem. 2015; 59: 1-41.

[35] Trono D. Recombinant Enzymes in the Food and Pharmaceutical Industries. In: Advances in Enzyme Technology. Elsevier; 2019. pp. 349-87.

[36] Sanchez S, Demain AL. Enzymes and Bioconversions of Industrial, Pharmaceutical, and Biotechnological Significance. Org Process Res Dev. 2011; 15: 224-30.

[37] de la Fuente M, Lombardero L, Gómez—González A, Solari C, Angulo—Barturen I, Acera A, et al. Enzyme Therapy: Current Challenges and Future Perspectives. Int J Mol Sci. 2021; 22: 9181.

[38] Tripathy RK, Anakha J, Pande AH. Towards development of biobetter: L—asparaginase a case study. Biochim Biophys Acta Gen Subj. 2024; 1868: 130499.

[39] Prasad YR, Anakha J, Pande AH. Treating liver cancer through arginine depletion. Drug Discov Today. 2024; 29: 103940.

[40] Enzyme Replacement Therapy Market Size, Share & Industry Analysis [Internet]. Fortune Business Insights; c2024 [cited 2024 Jun 7]. Available from: https://www.fortunebusinessinsights.com/enzyme—replacement—therapy—market—106424

[41] Enzyme Replacement Therapy Market Size [Internet]. Delaware: Global Market Insights Inc.; c2024 [cited 2024 Jun 7]. Available from: https://www.gminsights.com/industry—analysis/enzyme—replacement—therapy—market

[42] COVID—19 Vaccines for 2024—2025 [Internet]. U.S. Food and Drug Administration; [cited 2024 Jun 10]. Available from: https://www.fda.gov/emergency—preparedness—and—response/coronavirus—disease—2019—covid—19/covid—19—vaccines—2024—2025

[43] Vaccines Market by Technology. Pune: MarketsandMarkets Research Private Ltd.; c2024 [cited 2024 Jun 10]. Available from: https://www.marketsandmarkets.com/Market—Reports/vaccine—technologies—market—1155.html

[44] World Health Organization, editor. Global vaccine market report 2023. Geneva: World Health Organization; 2024.

[45] Global Vaccine Market Size, Share, and Trends Analysis Report — Industry Overview and Forecast to 2031 [Internet]. DataBridge; [cited 2024 Jun 10]. Available from: https://www.databridgemarketresearch.com/reports/global—vaccines—market

[46] Vaccines & Immunizations [Internet]. Centre for Disease Control and Prevention; [cited 2024 Jun 10]. Available from: https://www.cdc.gov/vaccines/index.html

[47] Race for Immunity: Exploring the Evolving Landscape of the Vaccines Market [Internet]. IQVIA; c2023 [cited 2024 Oct 13]. Available from: https://www.iqvia.com/—/media/iqvia/pdfs/library/white—papers/race—for—immunity.pdf

[48] Sridharan K, Gogtay NJ. Therapeutic nucleic acids: current clinical status. Br J Clin Pharmacol. 2016; 82: 659-72.

[49] Belgrad J, Fakih HH, Khvorova A. Nucleic Acid Therapeutics: Successes, Milestones, and Upcoming Innovation. Nucleic Acid Ther. 2024; 34: 52-72.

[50] Abusalah MAH, Khalifa M, Al—Hatamleh MAI, Jarrar M, Mohamud R, Chan YY. Nucleic Acid—Based COVID—19 Therapy Targeting Cytokine Storms: Strategies to Quell the Storm. J Pers Med. 2022; 12: 386.

[51] Ning L, Liu M, Gou Y, Yang Y, He B, Huang J. Development and application of ribonucleic acid therapy strategies against COVID—19. Int J Biol Sci. 2022; 18: 5070-85.

[52] Nucleic Acid Therapeutics CDMO Market Size, Share & Trends Analysis Report By Type (Gene Therapy, RNA—based Therapies), By Service, By End—use, By Application, By Region, And Segment Forecasts, 2024 — 2030 [Internet]. San Francisco: Grand View Research, Inc.; c2024 [cited 2024 Oct 13]. Available from: https://www.grandviewresearch.com/industry—analysis/nucleic—acid—therapeutics—cdmo—market—report

[53] Malech HL, Garabedian EK, Hsieh MM. Evolution of Gene Therapy, Historical Perspective. Hematol Oncol Clin North Am. 2022; 36: 627—45.

[54] Kulkarni JA, Witzigmann D, Thomson SB, Chen S, Leavitt BR, Cullis PR, et al. The current landscape of nucleic acid therapeutics. Nat Nanotechnol. 2021; 16: 630—43.

[55] Nucleic Acid—Based Therapeutics Market Size & Share Analysis — Growth Trends & Forecasts (2024 — 2029) [Internet]. Hyderabad: Mordor Intelligence; c2024 [cited 2024 Jun 10]. Available from: https://www.mordorintelligence.com/industry—reports/nucleic—acid—based—therapeutics—market

[56] Bashor CJ, Hilton IB, Bandukwala H, Smith DM, Veiseh O. Engineering the next generation of cell—based therapeutics. Nat Rev Drug Discov. 2022; 21: 655-75.

[57] Xie G, Dong H, Liang Y, Ham JD, Rizwan R, Chen J. CAR—NK cells: A promising cellular immunotherapy for cancer. EBioMedicine. 2020; 59: 102975.

[58] Stoddard—Bennett T, Reijo Pera R. Treatment of Parkinson’s Disease through Personalized Medicine and Induced Pluripotent Stem Cells. Cells. 2019; 8: 26.

[59] Huang L, Fu C, Xiong F, He C, Wei Q. Stem Cell Therapy for Spinal Cord Injury. Cell Transplant. 2021; 30: 963689721989266.

[60] Hoang DM, Pham PT, Bach TQ, Ngo ATL, Nguyen QT, Phan TTK, et al. Stem cell—based therapy for human diseases. Signal Transduct Target Ther. 2022; 7: 272.

[61] Zaib S, Saleem MA, Khan I. CRISPR—Cas9 Genome Engineering: Trends in Medicine and Health. Mini Rev Med Chem. 2022; 22: 410-21.

[62] Cell Therapy Market Size, Share, Growth Analysis, By Therapy Type [Internet]. SkyQuest Technology Consulting Pvt. Ltd.; c2024 [cited 2024 Jun 10]. Available from: https://www.skyquestt.com/report/cell—therapy—market

[63] Cell Therapy Market Size, Share & Trends Analysis Report By Therapy Type [Internet]. San Francisco: Grand View Research, Inc.; c2024 [cited 2024 Jun 10]. Available from: https://www.grandviewresearch.com/industry—analysis/cell—therapy—market

[64] Recombinant Coagulation Factors Market Size, Share, Growth Analysis, By Product [Internet]. SkyQuest Technology Consulting Pvt. Ltd.; c2024 [cited 2024 Jun 10]. Available from: https://www.skyquestt.com/report/recombinant—coagulation—factors—market