Regulatory overview of biosimilars in Europe

Journal Title: International Journal of Drug Regulatory Affairs - Year 2018, Vol 6, Issue 3

Abstract

A biosimilar is a biological medicine similar, but not identical, to an already registered reference bio therapeutic product in terms of quality, safety, and efficacy. These drugs are also called as biosimilar products„, follow-on protein products‟ and subsequent-entry biologics„. The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally. Since the EU approved the first biosimilar in 2006, healthcare professionals have gained increasing experience with their use. Today, biosimilars are an integral part of the effective biological therapies available in the EU, supported by adequate safeguards protecting patient safety. In Europe, in 2001, legislation concerning biosimilar was codified as Directive 2001/83/EC to create a new marketing authorization procedure for similar biological medicinal products and also Committee for Medicinal Products for Human Use (CHMP) of the EMA is concern with these biosimilar products. The aim of biosimilars development is to demonstrate bio similarity - high similarity in terms of structure, biological activity and efficacy, safety and immunogenicity profile. Safety of biosimilars is monitored through pharmacovigilance activities, in the same way as for any other medicine. Biosimilars can offer advantages to EU healthcare systems, as it is expected to improve patients‟ access to safe and effective biological medicines with proven quality.

Authors and Affiliations

Shailaja Pashikanti, Jyothi Sri Durga V, Sowmya A. N. V. L

Keywords

Related Articles

EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS

Pharmaceutical drug development had become very costly and time consuming. There is an estimate that a drug from molecular development to marketing approvals cost $800 Millions. Drug approval process is time consuming pr...

REVIEW ON OCULAR DRUG DELIVERY SYSTEM AND ITS DEVICES

Ocular drug delivery system for the treatment of eye diseases has become popular and feasible in the past few years. Improving ocular contact time, enhancing corneal permeability and site specificity are the key points f...

QUALITY BY DESIGN- A NEW APPROACH TO DRUG DEVELOPMENT

Quality by design is an essential part of the modern approach to pharmaceutical quality. A new approach to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important busi...

CONDUCIVE ENVIROMENT FOR FOSTERING INDIA SPECIFIC INNOVATION: NEW MEDICAL DEVICE RULES 2017

The medical technology sector in India valued at approximately $ 10 billion in 2015 at end consumer prices and is growing at 10-12 percent annually. Currently, the Indian medical devices industry represents just over 2 p...

REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND

The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved f...

Download PDF file
  • EP ID EP426949
  • DOI 10.22270/ijdra.v6i3.270
  • Views 116
  • Downloads 0

How To Cite

Shailaja Pashikanti, Jyothi Sri Durga V, Sowmya A. N. V. L (2018). Regulatory overview of biosimilars in Europe. International Journal of Drug Regulatory Affairs, 6(3), 40-44. https://europub.co.uk/articles/-A-426949