BIOLOGICALS AND BIOSIMILAR: ADVANCING HEALTHCARE THROUGH INNOVATION AND ACCESSIBILITY

Pradeep Pal, Anjali Chorasiya, Akanshag Jawani, Chalsy Rathore, Mangal Singh Panwar

Abstract

“Biologics” considered one of the fastest growing sectors of the pharmaceutical industry; “Biologics” have introduced many new treatments for life-threatening and rare diseases. The first generation of bio pharmaceutical products produced using recombinant technologies was launched in the 1980s and is now on the way to patent expiration. As a result, research and generic pharmaceutical companies are seizing the opportunity to develop “generic” substitutes for original biologics, referred to here as biosimilars. However, the process of introducing an innovator's biosimilar product is much more complex than the relatively straightforward process of introducing a generic equivalent of an innovator's product based on a new chemical entity. Biologics are produced by cells in culture or whole organisms, which are inherently more variable than chemical synthesis methods. Therefore, unlike generic drugs, it is not possible to create an identical or identical copy of the innovator product. In this way, biosimilars are "similar but not the same" or in other words biosimilars are "a twin but not a clone" of the original biologic innovator product. The field of biosimilars therefore presents several important challenges, including i) validation of similarity, ii) interchangeability of biosimilar and innovative products, iii) possible need for a unique nomenclature to distinguish different bio pharmaceutical products, iv) regulatory framework, v) business opportunities as well as guidance for assistance to manufacturers in product development, vi) intellectual property rights and vii) public safety.

Keywords: Biosimilars, Biological drugs, Innovative product, Pharmacovigilance.

References

Sekhon BS, Saluja V. (2011), Biosimilars: An overview, Biosimilars. 1:1-11.

Dranitsaris G, Amir E, Dorward K. (2011), Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations, Drugs, 71:1527-1536.

Kay J. (2011), Biosimilars: A regulatory perspective from America, Arthritis Res Ther. 13:112.

World Health Organization. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). Geneva: WHO; 2009. Available from: http://www.who.int/biologicals/publications/trs/areas/biological_ therapeutics/BS2110Dft_guidelines_Final_HK_IK_29 July_09.pdf. Accessed June 1, 2012.

Roger SD (2010), Biosimilars: Current status and future directions, Expert Opin Biol Ther. 10:1011-1018.

Comisión Federal para la Protección contra Riesgos Sanitarios. Registros sanitarios de medicamentos. 2012. Available from: http://www.cofepris.gob.mx/AS/Paginas/Registros%20Sanitarios/ RegistroSanitarioMedicamentos.aspx. Accessed July 2, 2012.

Centro para el Control Estatal de Medicamentos. Medicamentos y biológicos-aprobados. 2012. Available from: http://www.cecmed. sld.cu/Docs/RegSan/RegSanMed.xls. Accessed June 2012.

Dirección General de Drogas y Farmacias. Consulta medicamentos. 2012. Available from.http://drogasyfarmacias.gov.do/index.php?option=com_ wrapper & view=wrapper& Itemid=437. Accessed July 5, 2012.

Dirección General de Drogas y Farmacias. Requisitos medicamentos. 2012. Available from: http://www.drogasyfarmacias.gov.do/index.php. Accessed July 5, 2012.

Departamento de Salud Gobierno de Puerto Rico. [Homepage on the Internet.] Available from: http://www.salud.gov.pr. Accessed July 5, 2012.

Departamento de Salud Gobierno de Puerto Rico. Reglamentos. 2007. Available from:http://www.salud.gov.pr/Publicaciones/Reglamentos/ Pages/default.aspx. Accessed July 5, 2012.

Knezevic I, Griffiths E. (2011), Biosimilars - Global issues-national solutions, Biologicals, 39:252-255.

Castanheira LG, Barbano DB, Rech N. (2011), Current development in regulation of similar biotherapeutic products in Brazil. Biologicals, 39:308-311.

Ministerio de Salud. Sistema de Consulta de Productos Registrados: Reditux concentrado para solución para infusión 10 mg/mL. 2010. Available from: http://200.68.11.21/RegistrosISP/fiFichaProducto. asp?RegistroISP=B-2142/10. Accessed July 2, 2012.

Pombo ML (2011), Biotechnological products in Pan American Health Organization (PAHO): regional efforts towards harmonization of regulation, Biologicals, 39:348.

Pombo ML, Di Fabio JL, Cortés MDlA. (2009), Review of regulation of biological and biotechnological products in Latin American and Caribbean countries, Biologicals, 37:271-276.

Presidente de los Estados Unidos Mexicanos. Decreto por el que se adiciona un artículo 222 Bis a la Ley General de Salud. 2009. Available from: http://dof.gob.mx/nota_detalle.php?codigo=5094117&fecha=11/ 06/2009. Accessed July 2, 2012.

Wang T., Chu L., Li W., Lawson K., Apostol I., Eris T. (2017), Application of a quantitative LC-MS multiattribute method for monitoring site-specific glycan heterogeneity on a monoclonal antibody containing two N-linked glycosylation sites, Anal. Chem. 89:3562-3567. https://doi.org/10.1021/acs.analchem.6b04856.

Largy, E., Cantais F., Van Vyncht G., Beck A., Delobel A. (2017), Orthogonal liquid chromatography-mass spectrometry methods for the comprehensive characterization of therapeutic glycoproteins, from released glycans to intact protein level. J. Chromatogr. A 2017, 1498, 128-146. https://doi.org/10.1016/j.chroma.2017.02.072.

Mouchahoir T, Schiel JE (2018), Development of an LC-MS/MS peptide mapping protocol for the NISTmAb. Anal. Bioanal. Chem. 410, 2111–2126. https://doi.org/10.1007/s00216-018-0848-6.

Gajadhar A, Fisher T., Scientific S.J. (2020), Sure Quant Intelligence-Driven MS: A New Paradigm for Targeted Quantitation.

European Medicines, A., Commission, E. Biosimilars in the EU-Information guide for healthcare professionals. 2019.

Food US, Drug A. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for Industry 2015.

Rugo HS, Linton KM Cervi P, Rosenberg JA, Jacobs, I (2016) A clinician’s guide to biosimilars in oncology. Cancer Treat. Rev. 46, 73-79. https://doi.org/10.1016/j.ctrv.2016.04.003.

Kim H, Alten R, Avedano L, Dignass A, Gomollón F, Greveson K, Halfvarson J, Irving PM, Jahnsen J, Lakatos PL (2020) The future of biosimilars: Maximizing benefits across immune-mediated inflammatory diseases. Drugs, 80:99-113.

Hemmer B, Wiendl H, Roth K, Wessels H, Hofler J, Hornuss C, Liedert B, Selmaj K (2023), Efficacy and safety of proposed biosimilar Natalizumab (PB006) in patients with relapsing-remitting multiple sclerosis: The antelope phase 3 randomized clinical trial. JAMA Neurol. 80, 298-307. https://doi.org/10.1001/jamaneurol.2022.5007.

Kesik-Brodacka M (2018) Progress in biopharmaceutical development. Biotechnol. Appl. Biochem. 65:306-322. https://doi.org/10.1002/bab.1617.

Cazap E., Jacobs I., McBride A., Popovian R., Sikora K. (2018) Global acceptance of biosimilars: Importance of regulatory consistency, education, and trust. Oncologist 223:1188-1198. https://doi.org/10.1634/theoncologist.2017-0671.

Christl, L. (2016), FDA’s overview of the regulatory guidance for the development and approval of biosimilar products in the US; US Food and Drug Administration: Silver Spring, MD, USA.

Singh A, Kalaivani M, Srivastava S, Goyal RK, Gupta SK (2020) Postmarketing Safety of Biosimilars: Current status, challenges, and opportunities in the spontaneous reporting system. Ther. Innov. Regul. Sci. 54:667-680. https://doi.org/10.1007/s43441-019-00101-6.

Kabir ER, Moreino SS, Sharif Siam MK (2019) The breakthrough of biosimilars: A twist in the narrative of biological therapy. Biomolecules 9:410. https://doi.org/10.3390/biom9090410.

Ascef, BO, Lopes ACF, de Soarez PC (2020) Health technology assessment of biosimilars worldwide: A scoping review. Health Res. Policy Syst. 18:95. https://doi.org/10.1186/s12961-020-00611-y.

Konstantinidou, S.; Papaspiliou, A.; Kokkotou, E. Current and future roles of biosimilars in oncology practice. Oncol. Lett. 2020, 19, 45–51. https://doi.org/10.3892/ol.2019.11105.

Tkaczuk K.H.R, Jacobs I.A. (2014), Biosimilars in oncology: From development to clinical practice. Semin. Oncol. 41:S3-S12.

Lyman, G.H., Balaban E., Diaz M., Ferris A., Tsao A., Voest E., Zon R., Francisco M., Green, S., Sherwood S (2018), American society of clinical oncology statement: Biosimilars in oncology. J. Clin. Oncol.,36:1260-1265. https://doi.org/10.1200/JCO.2017.77.4893.

Peyrin-Biroulet L, Lonnfors S, Roblin X, Danese S, Avedano L (2017) Patient perspectives on biosimilars: A survey by the european federation of crohn’s and ulcerative colitis associations. J. Crohns Colitis, 11:128-133. https://doi.org/10.1093/eccojcc/jjw138.

Planes S, Villier C, Mallaret M (2016) The nocebo effect of drugs. Pharmacol. Res. Perspect. 4:e00208. https://doi.org/10.1002/prp2.208.

Rezk MF, Pieper B. (2017) Treatment outcomes with biosimilars: Be aware of the nocebo effect. Rheumatol. Ther. 4:209–218. https://doi.org/10.1007/s40744-017-0085-z.

Ghil, J., Niebrzydowski J., Zielińska A., Lee Y (2017) FRI0198 usability and safety of SB5 (An adalimumab biosimilar) pre-filled syringe and pre-filled pen in patients with rheumatoid arthritis. Ann. Rheum. Dis., 76:556.

Kijanka M, Dorresteijn B, Oliveira S (2015) van Bergen en Henegouwen, P.M. Nanobody-based cancer therapy of solid tumors. Nanomedicine 10:161–174. https://doi.org/10.2217/nnm.14.178.

Schellekens H, Lisman J, Bols T. (2008) Biosimilars in clinical practice - The challenges for hospital pharmacists. EJHPP Practice, 14:32-33.

Generic Pharmaceutical Association. Press release. February 1, 2010. www.gphaonline.org. Accessed February 4, 2010.

Federal Trade Commission. FTC releases report on Follow-on Biologic Drug Competition. June 10, 2009. www.ftc.gov/opa/2009/06/biologics. shtm. Accessed February 4, 2010.

http://www.incresearch.com/Resource/Foresight/Foresight_201010- Biosimilars.pdf. 88. Promise of biosimilars tempered by complexity, caution. January 10, 2011; http://www.hemonctoday.com/article.aspx?rid=79243.

http://www.amarexcro.com/articles/docs/RAPS_Focus_Biosimilars_ Apr2010.pdf. Regulatory Focus, April 2010:21-26.

Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Omol. 2008;19:411–419. 91. Background on Biosimilars. http://www.pahef.org/en/news/ 2-news/228-pahef-hosts-two-workshops-in-mexico-to-educate-aboutsafety-of-biosimilars.html.

http://www.faqs.org/periodicals/201007/2127490141.html#ixzz1 BpLJT0d6.

Salem T, Harvie B. (2010) Biosimilar medicines and their use: the nurse’s role and responsibility. Renal Soc Aust J. 6:76-80.

Schellekens H, Lisman J, Bols T (2008) Biosimilars in clinical practice-The challenges for hospital pharmacists. EJHPP Practice. 14:32-33.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/Therapeutic BiologicApplications/Biosimilars/default.htm. November 2010.

Declerck PJ, Darendeliler F, Góth M (2010) Biosimilars: controversies as illustrated by rhGH. Curr Med Res Opin. 26:1219-1229.

Hospira symp on assessing biosimilars. http://www.thepharmaletter. com/file/89334/hospira-symp-on-assessing-biosimilars.html

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