Biosimilar monoclonal antibodies—challenges and opportunities in Europe

Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 3

Abstract

New regulations for the development of biosimilars have been introduced in Europe and a new class of biosimilars – monoclonal antibodies – is expected on the market soon, which will both challenge and benefit our healthcare systems.

Authors and Affiliations

Andrea Laslop

Keywords

Related Articles

What to look forward to in GaBI Journal, 2012, issue 2

It is my pleasure to introduce the second edition of GaBI Journalwhich contains a number of interesting articles. Professors Benjamin and Kearns present a review of advances in paediatric drug development and labelling,...

US state legislation on biosimilars substitution

Despite the fact that US Food and Drug Administration has yet to receive a biosimilars application, many US states have been considering legislation which could potentially limit biosimilars substitution.

Recent trends and special topics in new drug review in PMDA

The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory agency, which works together with the Ministry of Health, Labour and Welfare. At the 24th Drug Information Association Annual EuroMeeting in Mar...

ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities

The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scient...

‘Similar biologics’ approved and marketed in India

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory aut...

Download PDF file
  • EP ID EP354838
  • DOI 10.5639/gabij.2013.0203.034
  • Views 121
  • Downloads 0

How To Cite

Andrea Laslop (2013). Biosimilar monoclonal antibodies—challenges and opportunities in Europe. Generics and Biosimilars Initiative Journal, 2(3), 110-111. https://europub.co.uk/articles/-A-354838