Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2014 Jul;4(2):63-6.
doi: 10.4103/2229-516X.136774.

Biosimilar drugs: Current status

Rajiv Kumar  1 , Jagjit Singh  1
Affiliations
Review

Biosimilar drugs: Current status

Rajiv Kumar et al. Int J Appl Basic Med Res. 2014 Jul.

Abstract

Biologic products are being developed over the past three decades. The expiry of patent protection for many biological medicines has led to the development of biosimilars in UK or follow on biologics in USA. This article reviews the literature on biosimilar drugs that covers the therapeutic status and regulatory guidelines. Appraisal of published articles from peer reviewed journals for English language publications, search from PubMed, and guidelines from European Medicines Agency, US Food Drug Administration (FDA) and India were used to identify data for review. Literature suggest that biosimilars are similar biological products, i.e., comparable but not identical to the reference product, are not generic version of innovator product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and marketing approval is also more complicated. To improve access, US Congress passed the Biologics Price Competition and Innovation act 2009 and US FDA allowed "abbreviated pathway" for their approval. U.S law has defined new standards and terms and EMA scientific guidelines have also set detailed approval standards. India being one of the most preferred manufacturing destinations of biosimilars, there is a need for stringent safety and regulatory guidelines. The New India Guidelines "Draft Guidelines on Similar Biologics were announced in June 2012, by Department of Biotechnology at Boston bio and available online.

Keywords: Biologicals; European Medicines Agency; Food Drug Administration; India; biosimilars; guidelines.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: None declared.

References

    1. Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies: Regulatory, clinical and commercial considerations. Drugs. 2011;71:1527–36. - PubMed
    1. Crommelin DJ, Storm G, Verrijk R, de Leede L, Jiskoot W, Hennink WE. Shifting paradigms: Biopharmaceuticals versus low molecular weight drugs. Int J Pharm. 2003;266:3–16. - PubMed
    1. Brockmeyer C, Seidl A. Binocrit: assessment of quality, safety and efficacy of biopharmaceuticals. Eur J Hosp Pharm Pract. 2009;15:34–40.
    1. Schellekens H, Casadevall N. Immunogenicity of recombinant human proteins: Causes and consequences. J Neurol. 2004;251(Suppl 2):II4–9. - PubMed
    1. The New India Guidelines on Similar Biologics. 2012. Oct, [Last accessed on 2013 Jul 16]. Available from: http://www.biospectrumasia.com/biospectrum/analysis/3021/biosimilars-gui... .