Journal of Pharmacy And Bioallied Sciences
Journal of Pharmacy And Bioallied Sciences Login  | Users Online: 989  Print this pageEmail this pageSmall font sizeDefault font sizeIncrease font size 
    Home | About us | Editorial board | Search | Ahead of print | Current Issue | Past Issues | Instructions | Online submission

 Table of Contents  
Year : 2013  |  Volume : 5  |  Issue : 1  |  Page : 80-81  

Biosimilars: Current regulatory perspective and challenges

1 Global Medical Information and Scientific Affairs, Inventiv-I3, Gurgaon, India
2 Department of Pharmacy, Birla Institute of Technology and Sciences - Pilani, Hyderabad Campus, R. R. District Hyderabad, Andhra Pradesh, India

Date of Web Publication28-Jan-2013

Correspondence Address:
Diwakar Jha
Global Medical Information and Scientific Affairs, Inventiv-I3, Gurgaon
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0975-7406.106569

Rights and Permissions

How to cite this article:
Jha D, Mishra RK, Pandey R. Biosimilars: Current regulatory perspective and challenges. J Pharm Bioall Sci 2013;5:80-1

How to cite this URL:
Jha D, Mishra RK, Pandey R. Biosimilars: Current regulatory perspective and challenges. J Pharm Bioall Sci [serial online] 2013 [cited 2020 Oct 27];5:80-1. Available from:


Biosimilars-the generic version of biologicals is the new buzz word in pharmaceutical industry.With annual growth rate of 7%, the sector is expected to grow to $172 billion by 2015. [1] Biosimilars are highly similar to licensed reference product notwithstanding minor differences in clinically inactive components; also there are no clinically meaningful differences between the biologicals and the reference product in terms of safety, purity, and potency.

Beginning with human insulin, human growth hormone, and erythropoietin (1982, 1985, and 1989) >200 biosimilars have hit market. The market for erythropoietin was worth $13 billion in 2011, ahead of Lipitor which had market of $12.4 billion in 2008 ($12.4 billion in 2011). [2]

Biologicals differ from conventional generics in size, structure, stability, in-built heterogeneity, and analytical characterization. Their unique multidimensional structure and complicated mode of action are never fully reproducible. Even with same molecular weight and production by same type of cells, they possess different properties, e.g., European Medicines Agency (EMEA) rejected the biosimilar Alpheon (interferon-oL) due to a higher number of AEs and more frequent recurrence of disease in patients treated with Alpheon than reference-Roferon-A. For immunoglobulins, small differences in core fucosylation led to big changes in receptor binding and consequently impacted immune functions like cellular cytotoxicity. [2]

The classical paradigm of bioequivalence cannot be applied to protein drugs as evident from case of Retacrit. EMEA/Committee for Medicinal Products for Human Use (CHMP) burgeoned the concept of biosimilarity. Biosimilars' approval should consider exactly same high standards and stringent requirements for quality, efficacy, or safety. First recommendation for the approval of biogenerics came in 2004 by the European Parliament. By 2011, 14 marketing authorizations were made by EMEA. EMEA lays that biosimilars be fully characterized for physicochemical and biophysical attributes. [3] Guidelines are laid for human soluble insulin, somatropin, granulocyte colony stimulating factor (G-CSF), and epoetins. With France as only exception, there are no regulations in other countries of EU. Australia adopted the EMEA guidelines, whereas Japan and Singapore issued guidelines in 2009, followed by Health Canada in 2010. WHO and some national guidance documents recommend EMEA approaches. FDA recommends two approaches: (1) biosimilar approach and (2) stand-alone approach. The guidelines are under construction and vary case to case. Sandoz's somatropin product, Omnitrope, was approved by FDA, but this pathway cannot be used for other products. [4] Till recently in India, marketing authorizations were in line with US approach. In July 2012, "Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India" was introduced. It draws cues from EMEA/ICH guidelines. [5]

The main points to consider about biosimilars are their safety, automatic substitution, naming, and labeling/prescription. The safety profile of biosimilars is not identical to reference as seen for biosimilar growth hormone, Valtropin, which had different precautions and warnings from reference, Humatrope. The immunogenicity of biosimilars cannot be fully predicted using preclinical/clinical studies. Robust pharmacovigilance still remains critical consideration. The story of epoetin therapy is instructive and called for subtle changes in manufacturing. Biosimilars cannot have the same international non-proprietary name as innovator. ''Quality by design" approach provides assurance of quality of the reference product but requires critical understanding of variability ofevery product attribute. A manufacturer may well establish the design space for his product but cannot use this concept to ensure similarity with the reference. Every biological is different and healthcare professionals should interchange biologicals after careful analysis of supporting data. [2]

   References Top

1.Biosimilars. Macroview event reports, 2009. Available from: [Last Updated on 2010 Aug 01].  Back to cited text no. 1
2.Jo P, Yann B. Opportunities and barriers in the biosimilar market: Evolution or revolution for generics companies? Pharmaceutical strategy consultants at pricewaterhouse Coopers LLP, 2006. Available from: [Last accessed 2010 Sep 04].  Back to cited text no. 2
3.European Medicines Agency. Committee for medicinal products for human use. Guideline on similar biological medicinal products, 2005. Available from: [Last Updated on 2005 Oct 30].  Back to cited text no. 3
4.Ahmed I, Kaspar B, Sharma U. Biosimilars: Impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Clin Ther 2012;34:400-19.  Back to cited text no. 4
5.DBT and CDSCO. Guidelines on Similar Biologics: Regulatory requirements for marketing authorization in India, 2012. Available from: [Last Updated on 2012 Jun 05].  Back to cited text no. 5

This article has been cited by
1 Perception of Originator Biologics and Biosimilars: A Survey Among Belgian Rheumatoid Arthritis Patients and Rheumatologists
Eline van Overbeeke,Birgit De Beleyr,Jan de Hoon,Rene Westhovens,Isabelle Huys
BioDrugs. 2017; 31(5): 447
[Pubmed] | [DOI]


    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
    Access Statistics
    Email Alert *
    Add to My List *
* Registration required (free)  

  In this article

 Article Access Statistics
    PDF Downloaded131    
    Comments [Add]    
    Cited by others 1    

Recommend this journal