Biosimilars Regulation in the United States and FDA Approved Biosimilars from 2015-2018

Author(s): Vikram, Aakash Deep*, Manita, Avtar C. Rana, Monu Yadav, Rakesh K. Marwaha

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 1 , 2020

Become EABM
Become Reviewer

Graphical Abstract:


Abstract:

Background: Biological products are the chemicals in the form of medicines that are prepared from the living cells through highly intricate manufacturing techniques that should be handled and managed under favorable conditions. The regulation of the biosimilar products consists of significant challenges, since they are part of the growing sector of the pharmaceutical industry and normally used by human beings. The regulatory framework and the technical requirements of the US biosimilars program involve a stepwise approach that relies heavily on analytical methods to demonstrate through a “totality of the evidence” that a proposed product is biosimilar to its reference product. By integrating analytical, pharmacological, and clinical data, each of which has limitations, a high level of confidence can be reached regarding clinical performance. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the health reform (Affordable Care Act).

Objective: The current manuscript will provide the information regarding the regulation of Biosimilars products with the detail of biosimilar USER fees structure and the list of approved biosimilar by FDA from 2015- 2018.

Conclusion: Research is continually developing more biological products that will help treat medical conditions or add some innovation to the existing treatment options. Biosimilars and reference products are generated in the living cells and require trained expertise as well as technology for biologics being usually highly effective compared to small molecule drugs. These are usually specific against the respective target, which generally produces lesser side effects and low toxicity. FDA’s regulatory authority for the approval of biologics is under PHS (Public Health Service Act) which are also suggested to regulate under the Federal Food, Drug and Cosmetics Act (FD&C). Biosimilars can help expand access to high-quality treatment options for doctors and patients, as well as reduce costs for the healthcare system.

Keywords: Biosimilars, regulation, FDA approved biosimilar products, vaccine, biological products, therapeutic serum.

[1]
Barakat NS. Biological products: Manufacturing, handling, packaging and storage. Promising Pharma 2012; 23: 63-82.
[2]
Zwebb H. FDA definitions of generics and biosimilars / general / biosimilars / home - gabi online - generics and biosimilars initiative 2018.[cited: 5 October 2018] Available from: http://gabionline.net/Bio similars/General/FDA-definitions-of-generics-and-biosimilars
[3]
Ventola CL. Biosimilars part 1: proposed regulatory criteria for FDA approval. Pharmacol and Ther 2013; 38(5): 270.
[5]
Zuñiga L, Calvo B. Regulatory aspects of biosimilars in Europe. Trends Biotechnol 2009; 27(7): 385-7.
[6]
Sekhon B, Saluja V. Biosimilars: an overview. Biosimilars 2011; 1: 1-11.
[7]
Mounho-Zamora B. Regulatory standards for the approval of biosimilar products: a global review In nonclinical development of novel biologics, biosimilars, vaccines and specialty biologics. Academic press 2013; pp. 159-84.
[9]
Banthia V. Biosimilar regulation: bringing the United States up to speed with other markets. Minn J Law Sci & Technol 2015; 16: 879.
[10]
Johnson JA. Biologics and biosimilars: background and key issues. Congressional Research Service, Library of Congress 2019; [cited: 6 June 2019] Available from: https://fas.org/sgp/crs/misc/R44620.pdf
[12]
Biosimilar user fee act 2018.[cited: 22 September 2018] Available from: https://www.pbwt.com/con tent/uploads/2016/09/FY-2013-BsUFA-Performance-Report.pdf
[13]
Dabrowska A, Johnson JA, Sarata AK, Thaul S. FDA human medical product user fee programs: in brief 2018. [cited: 26 September 2018] Available from: https://fas.org/sgp/crs/misc/R44750.pdf
[14]
Food and drug administration department of health and human services. Biosimilar user fee act of 2012; [cited: 24 September 2018] Available from: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialRep orts/BsUFA/UCM605987.pdf
[15]
One hundred fifteenth congress of the United States of America 2018; [cited: 24 September 2018] Available from: https://www.congress.gov/115/bills/ hr2430/BILLS-115hr2430enr.pdf
[16]
Proposed FDA user fee acts: generic drug user fee amendments of 2012 (GDUFA) and Biosimilar user fee act of 2012 (BSUFA) 2018; [cited: 30 September 2018]. Available from:.https://www.everycrsreport. com/files/20120518_R42540_2251e4ffd6bc4a8f23ed7070719fa6fbba4ddb1f.pdf
[17]
U.S Food and Drug Administration. Five-year financial plan; biosimilar user fee act, food and drug administration department of health and human services ; 2018.[cited: 1 October 2018]. Available from: . https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/UserFeeFive YearFinancialPlans/UCM603100.pdf
[18]
Zwebb h. FDA issues final guidance on biosimilar user fees / Guidelines / Home - GaBI Online - Generics and Biosimilars Initiative 2018. [cited: 3 October 2018] Available from: http://www.gabionline.net/ Guidelines/FDA-issues-final-guidance-on-biosimilar-user-fees
[19]
Pyndiah N. BsUFA II fees - are you aware of the major changes? 2018. [cited: 5 October 2018] Available from: https://hartmannwillner.com/uncategorized/ bsufa-ii-fees-are-you-aware-of-the-major-changes/
[20]
Mezher M. FDA finalizes guidance on biosimilar user fees under BsUFA II 2018. [cited: 4 October 2018] Available from: https://www.raps.org/news-and-articles/news-articles/2018/6/fda-finalizes-guidance-on-biosimilar-user-fees-und
[21]
Leslie K. Food and drug administration, biosimilar user fee rates for fiscal year 2018.[cited 4 October 2018] Available from: https://www.gpo.gov/fdsys/ pkg/FR-2012-08-01/pdf/2012-18712.pdf
[22]
Food and drug administration, biosimilar user fee rates for fiscal year 2014.[cited 5 October 2018] Available from: https://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18621.pdf
[23]
Food and drug administration, biosimilar user fee rates for fiscal year 2015.[cited: 6 October 2018] Available from: https://www.gpo.gov/fdsys/pkg/FR-2014-08-01/pdf/2014-18112.pdf
[24]
Food and drug administration, biosimilar user fee rates for fiscal year 2016. [cited: 7 October 2018] Available from: https://www.gpo.gov/fdsys/pkg/FR-2015-08-03/pdf/2015-18908.pdf
[25]
Food and drug administration, biosimilar user fee rates for fiscal year 2017.[cited: 13 October 2018] Available from: https://www.gpo.gov/fdsys/pkg/FR-2016-07-28/pdf/2016-17800.pdf
[26]
Biosimilar user fee amendments 2018.[cited: 14 October 2018] Available from: https://www.fda.gov/ ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ default.htm
[27]
Biosimilar biological product authorization performance goals and procedures fiscal years 2013 through 2017.[cited: 17 October 2018] Available from: https://www.biologicsblog.com/content/uploads/2016/09/BSUFA-Committment-letter-1-12-2012.pdf
[28]
FDA user fee program 2018. [cited: 19 October 2018] Available from: https://www.fda.gov/ForIn dustry/UserFees/BiosimilarUserFeeActBsUFA/ucm320768.htm
[29]
FDA releases biosimilar action plan. Center for Biosimilars 2018. [cited: 21 October2018] Available from: https://www.centerforbiosimilars.com/news/fda-releases-biosimilar-action-plan
[30]
FDA’s Dr. Gottlieb Chastises big pharma for biosimilars entry delays 2018. [cited: 23 October 2018] Available from: https://www.clinicaloncology.com/ FDA-Watch/Article/07-18/FDA-s-Dr-Gottlieb-Chasti ses-Big-Pharma-for-Biosimilar-Entry-Delays/51266
[31]
Watch B. FDA releases biosimilar action plan (BAP) to enhance biosimilar competition and market penetration. Big molecule watch. 2018. [cited: 24 October 2018] Available from: https://www.bigmoleculewatch.com/2018/07/18/fda-releases-biosimilar-action -plan-bap-to-enhance-biosimilar-competition-and-mar ket-penetration/
[32]
WSGR Alert - ninth circuit overturns altera and revives regulations on cost sharing of stock-based compensation 2018. [cited: 27 October 2018] Available from: https://www.wsgr.com/WSGR/Display.aspx? SectionName=publications/PDFSearch/wsgralert-BAP.htm
[33]
FDA announces biosimilars action plan with surprising rhetoric | biologics blog. Patterson Belknap Webb & Tyler llp. 2018. [cited: 28 October 2018] Available from: https://www.biologicsblog.com/fda-announces-biosimilars-action-plan-with-surprising-rhetoric
[35]
Frequently asked questions: biosimilars forums 2019. [cited: 21 January 2019] Available from: http://www.biosimilarsforum.org/sites/default/files/uploads/biosimilars_faqs_032816opt_0.pdf
[36]
White paper: breaking through biosimilars 2019.[cited: 21 January 2019] Available from: http://biosimilarscouncil.org/wp-content/uploads/2018/05/Breaking -Through-on-Biosimilars-Biosimilars-Council-White-Paper.pdf
[37]
Five barriers that could keep biosimilar manufacturers from cracking the US market. Deloitte Center for Health Solutions 2019. [cited: 21 January 2019] Available from: https://blogs.deloitte.com/centerfor healthsolutions/five-barriers-that-could-keep-biosimil ar-manufacturers-from-cracking-the-us-market/
[38]
Leber MB. Optimizing use and addressing challenges to uptake of biosimilars. Am J Manag Care 2018; 24(21)(Suppl.): S457-61.
[39]
Stevenson JG. Challenges with the introduction of biosimilars in the US. Am J Pharm Benefits 2016; 8(3): 93-6.
[40]
Chaudhari PS, Nath R, Gupta SK. Opportunities and challenges in biosimilar development. Bioprocess Int 2017; 15(5): 24-33.
[41]
Price W, Nicholson II, Rai AK. Manufacturing barriers to biologics competition and innovation. Iowa Law Rev 2015; 101: 10-23.
[42]
Rehman K, Bukhari NI. Equitable access to biosimilars: an overview Inequitable access to high-cost pharmaceuticals. 1st ed. . 2018; pp. 129-42.
[43]
Crespi-Lofton J, Skelton JB. The growing role of biologics and biosimilars in the United States: perspectives from the APhA biologics and biosimilars stakeholder conference. J Am Pharm Assoc 2017; 57(5): e15-27.
[44]
Brill A, Robinson C. Steps to Reducing Barriers to Biosimilars in the United States, Boehringer-inge lheim.us. 2019. [cited: 21 January 2019] Available from: https://www.boehringer-ingelheim.us/sites /us/f iles/files/barrierstobiosimilars_september2018.pf
[45]
Knezevic I, Sheets R. Biosimilars fundamentals of biologicals regulation: vaccines and biotechnology medicines. 1st ed. Academic Press 2018; pp. 345-58.
[46]
Biosimilar product information. FDA-approved biosimilar products 2018. [cited: 31 October 2018] Available from: https://www.fda.gov/Drugs/Develo pmentApprovalProcess/HowDrugsareDevelopedandA pproved/ApprovalApplications/TherapeuticBiologic Applications/Biosimilars/ucm580432.htm


Rights & PermissionsPrintExport Cite as

Article Details

VOLUME: 7
ISSUE: 1
Year: 2020
Page: [12 - 29]
Pages: 18
DOI: 10.2174/2213476X06666190213141839

Article Metrics

PDF: 17
HTML: 4
EPUB: 1
PRC: 1