Open Access Open Access  Restricted Access Subscription or Fee Access

A Futuristic concept of understanding Biosimilars in the Pharmaceutical Field

Mohammed Shakir Ghouse, Mohd Abdul Mugni Danish

Abstract


Biosimilars, which are highly similar versions of approved biologic drugs, are expected to continue their expansion into new therapeutic areas, offering cost-effective alternatives to a wider range of medical conditions. This evolution includes the development of next-generation biosimilars with improved properties, such as enhanced efficacy, safety, and patient convenience. Innovations in drug delivery methods, reduced immunogenicity, and personalized medicine are anticipated to drive the development of biosimilars tailored to individual patient characteristics. Regulatory agencies are refining the approval pathways for biosimilars, aiming for greater clarity and consistency, while interchangeability designations will enhance their adoption. Educational efforts targeting healthcare professionals, patients, and policymakers will build confidence in biosimilars and promote their wider use. Collaboration between biosimilar manufacturers, biopharmaceutical companies, and academic institutions will drive innovation, leading to improved biosimilar products and manufacturing processes. Additionally, the growing role of emerging markets and global regulatory harmonization will further facilitate access to biosimilars worldwide. The biosimilar field's continual evolution promises to enhance patient access to biologic therapies and improve treatment outcomes while contributing to the sustainability of healthcare systems.

Keywords


Biosimilars, cost-effective treatment, personalized medicine, new drug delivery methods, patient convenience.

Full Text:

PDF

References


FDA.Q5E Comparability of biotechnological /biological products subject to changes in their manufacturing process, 2005. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q5e-comparability-biotechnologicalbiological-products-subject-changes-their-manufacturing-process

FDA. Demonstration of comparability human biological products, including therapeutic biotechnology-derived products, 2005. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstration-comparability-human-biological-products-including-therapeutic-biotechnology-derived

The Mashelkar Committee report on recombinant pharmaceuticals. http://geacindia.gov.in/resource-documents/biosafety-regulations/policies-and-reports/Report-of-the-Task-Force-on-Recombinant-Pharma_Aug-2005.pdf

Scientific considerations in demonstrating biosimilarity to a reference product. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product

Schumi J, Witts JT. Through the looking glass: understanding non-inferiority. Trials, 2011; 12: 106.

Van den Bemt BJ, den Broeder AA, Wolbink GJ, et al. Anti-infliximab antibodies are already detectable in most patients with rheumatoid arthritis halfway through an infusion cycle: an open-label pharmacokinetics cohort study: BMC MusculoskeletDisord, 2011; 12: 12.

Schellekens H, Biosimmilars: the long and winding road to clinical equivalence. Hosp Pharm Europe, 2009; 47: 42-2.

Guidance for Industry: Q8 Pharmaceutical Development, US Department of Health and Human Services, Food and Drug Administration(FDA). May 2006. Q8 Annex Pharmaceutical Development, Step 3, November 2007.

PAT Guidance for Industry-A Framework for innovative pharmaceutical development, manufacturing and quality assurance. September 2004.

Kozlowski S. Swann P. Current and future issues in the manufacturing and development of monoclonal antibodies. Adv Drug Deliv Rev., 2006; 58: 707-722.

KVG. SchweizetBundesgesetzuber die Krankenversicherung: Art.52a Substitutionsrecht, 2000.

Schiesttl, Zabransky M, Sorgel F. Ten years of biosimilars in Europe development and evaluation of the regulatory pathways. Drug Des Devel Their, 2017; 11: 1509-15.

Sheridan C First generic biologics finally approved. Nat Rev Drug Discov, 2006; 5: 445.

Llano A, Fisher M, McKay G. Biosimilar insulin the current landscape. Pract Diabetes, 2017; 34: 51-4.

El Zorkany B, Al Ani N, Al Emadi S, Al Saleh J, Uthman I, EL Dershaby Y, et al. Bioimilar in rheumatology: recommendations for regulation and use in middle eastern countries. ClinRheumatol, 2018; 37: 1143-52.




DOI: https://doi.org/10.37591/(rrjops).v14i3.1353

Refbacks

  • There are currently no refbacks.


Copyright (c) 2023 Research and Reviews: A Journal of Pharmaceutical Science