REGULATORY CONSIDERATIONS OF BIOSIMILARS AND CLINICAL DILEMA OF THEIR USE

Sonja Genco Genadieva Stavrik, Aleksandra Grozdanova, Katerina Ancevska Netkovska, Magdalena Genadieva Dimitrova, Gligor Dimitrov

Abstract


Biomedical products are complex molecules, produced by living cells. More accurately, they are molecules that are naturally produced in the human body, like hormones or growth factors, monoclonal antibodies, blood products, immunological medicinal products, sera and vaccines, allergens, and advanced technology products such as gene and cell therapy products. Copies of these drugs, known as biosimilars, are comparable but not identical and are not generic version of innovator biological products. Specific regulatory requirements and abbreviated registration process apply in the case of biosimilars, in order to demonstrate efficacy and safety profile and to prove that product is similar to the original biomedical product.

Like all medicines, biological medicines work by interacting with the body to produce a therapeutic outcome, but the mechanisms by which they do this may vary from product to product and through indications. Therefore the role of the physicians in treatment of patients with these complex medicinal products is particularly important.

Regulatory issues, manufacturing, safety, physicians have part in develop use of biosimilars as much as generic drugs. Even though, the most important factor for market of biosimilar are commercial factor, still, real clinical dilemma of use are present, so it is necessary to have clear regulatory framework and postmarketing data on the use of biosimilars.


Keywords


biosimilars, innovate product, monoclonal antibodies, regulatory

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References


Gienentech Inc. Corporate Chronology. 1982. http://www.gene.com/gene/about/corporate/history/timeline.html.

Global Biopharmaceutical Market Report (2010-2015) IMARC October 29, 2010:234 pages. Pub ID:IMRC2849563.

Mc Kinnon RA, Lu CY. Biosimilars are not (bio)generics. Aust Prescr, 2009; 32(6):146-7.

Ledford H. Biosimilar drugs poised to penetrate market. Nature. 2010;468(7320):18-9.

Levy R. Karnofsky Lecture: Immunotherapy of lymphoma. J Clin Oncol 1999; 17(11 suppl): 7-12.

van Meerten T, Hagenbeek A. CD20 - target therapy: The next generation of antibodies. Semin Hematol. 2010; 47(2): 199-210.

Sousou T, Friedberg J. Rituximab in indolent lymphomas. Semin Hematol. 2010; 47(2): 133-42.

Zwick C, Murawski N, Pfeundshuh M, German High-Grade Non-Hodgkin Lymphoma Study Group. Rituximab in High-Grade Lymphoma. Semin Hematol. 2010; 47(2): 148-55.

Reichert JM, Rosenweig CJ, Faden LB , Dewitz MC. Monoclonal antibody successes in the clinic. Nat Biotechnol. 2005; 23(9): 1073-8.

Hirsch BR, Lyman GH. Biosimilars: A cure to the U.S. health care cost conundrum? Blood Rev. 2014; 28(6): 263-8.

Jahn EM, Schneider CK. How to systematically evaluate immunogenicity of theraeutic proteins- regulatory considerations. N Biotechnol. 2009; 25(5): 280-6.

Simoens S. Biosimilar medicines and cost-effectivness. Clinicoecon Outcomes Res. 2011; 3: 29-36.

Crommelin D, Bermejo T, Bissig M, et al. Pharmaceutical evaluation of biosimilars: important differences from generic low-molecular-weight pharmaceuticals. Eur J Hosp Pharm Sci. 2005;11(1):11–7.

Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology (Carlton). 2006;11(4):341–6.

Roger SD, Mikhail A. Biosimilars: opportunity or cause for concern? J Pharm Pharmaceut Sci. 2007;10(3):405–10.

Schellekens H. Follow-on biologics: challenges of the ‘next generation’. Nephrol Dial Transplant. 2005;20(suppl 4):31–6.

Mellstedt H. The future of biosimilars. Hosp Pharm Europe. 2010;49:33–4.

Long M, Trout J, Akpinar P. Biosimilars: HGH to TNFS, how will payers respond? ISPOR 12th Annual European Congress; October 26, 2009; Paris, France.

Danzon PM, Furukawa MF. Prices and availability of biopharmaceuticals: an international comparison. Health Aff (Millwood). 2006;25(5):1353–62.

Stanic Benic M, Jakovac S, Zekic T, Vlahovic-Palcevski V. Trend of Biosimilars Prescribing In A Croatian Teaching Hospital. Clin Ther. 2016;38(10S):e28.

Cesarec A, Liki? R. Budget impact analysis of biosimilar Trastuzumab for the treatment of breast cancer in Croatia. Appl Health Econ Health Policy. 2016 Oct 11. [Epub ahead of print].

European Generic Medicines Association. Biosimilars Handbook. 2nd ed. Brussels: European Generic Medicines Association, 2011.

Grozdanova A, Netkovska KA, Sterjev Z, Naumovska Z, Zarevski R, Dimovski A, et al. Biosimilar medical products - licensing, pharmacovigilance and interchangeability. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2016;37(1):27-36.

Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products. European Commission. Available at: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf.

EMA. Questions and Answers on Biosimilar Medi-cines, 2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062. pdf.

France to allow biosimilars substitution. 2014. Available at:http://www.gabionline.net/Policies-Legislation/Franceto-allow-biosimilars-substitution/(highlight)/france%20 substitution.

Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014; 124(22): 3191–6.




DOI: http://dx.doi.org/10.24125/sanamed.v1i1.158

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