• Vk
  • LinkedIn
  • Youtube
X7 Research
  • News
  • Registration strategy and Сonsulting
    • Budgeting
    • Registration strategy development
    • Study feasibility
    • Vendor selection
    • Data search and analysis
  • Clinical trials
    • Outsourcing CRAs in Russia and the EAEU
    • Development of medical documentation and biostatistics
    • Monitoring
    • Data-management
    • Patient home visits
    • Bioequivalence study
    • Therapeutic equivalence studies
    • Clinical trials of medical devices
  • Registration
    • Audit of the registration dossier
    • Bringing the registration dossier in compliance with the requirements of the EAEU
    • Conversion of registration dossier into XML format
    • PIL readability user testing
    • Translation of the Registration dossier
    • Turnkey registration
  • Post-authorization clinical studies
    • Phase IV studies
    • Non-interventional studies
    • Investigator-initiated studies
    • Post-authorisation safety study
    • Marketing research
  • Pharmacovigilance
    • QPPV in the EAEU
    • Safety monitoring of medical devices
    • Building a pharmacovigilance system
    • Safety in clinical trials
    • Pharmacovigilance audit
    • Pharmacovigilance contact person
  • Therapeutic expertise
    • Clinical trials in Oncology in the EAEU
  • Contact
  • EnglishEnglish
    • РусскийРусский
  • Menu

European regulatory stuff supports simple approach to biosimilars

17.04.2017/in News /by daryab

A large volume of comparative trials including preclinical and clinical data is required to demonstrate automatic substitution (EU terminology, or interchangeability by US terminology) as biosimilar product is developed by a different manufacturer using a different manufacturing process.

Since there is no official position on interchangeability of a biosimilars at the EU level, several EU national regulatory authorities developed their national positions on interchangeability. These agencies’ staff recently expressed possible issues and EU perspectives for biosimilars in the article published in BioDrugs journal.

Immunogenicity can be an issue when switching from reference biologic product to it’s biosimilar, but currently, the probability of acute hypersensitivity to biosimilar is near to zero as amino-acid sequence of both reference and biosimilar products is the same. However, manufacturing change can lead to lack of similarity and therefore in immunogenicity, and such subtle loss of interchangeability has been reported earlier. Several examples are reviewed by authors, but they still conclude that the risk of exaggerated immune reactions as a result of switching between a biosimilar and its reference products is substantially overrated.

Switching from a reference product to its biosimilar versions has been extensively studied for various products in modern randomized controlled trials with crossover design. These trials successfully demonstrated efficacy, safety and interchangeability of biosimilars. Analysis of EudraVigilance database reveals only 3 case reports that can possibly link adverse reactions to switching from reference to biosimilar product.

Considering all the evidence and pharmacovigilance data, authors conclude that further need for such trials is questionable, and the necessity to conduct such trials may discourage biosimilar development. Moreover, these trials assume increase sample size to achieve sufficient power taking the switching into account and adjusting for confounders. In the EU, no specific switching studies are required by legislation or by regulatory guidelines.

A state-of-the-art demonstration of biosimilarity, along with intensified post-marketing surveillance, is a sufficient and realistic way of ensuring interchangeability of EU-approved biosimilars under supervision of the prescriber.

While EU regulatory bodies support the current vision, industry can feel confident that there will be no further increase in either complexity or costs for biosimilar development.

 

Share this entry
  • Share on Twitter
  • Share on WhatsApp
  • Share on Pinterest
  • Share on LinkedIn
  • Share on Tumblr
  • Share on Vk
  • Share on Reddit
  • Share by Mail

YOU MAY ALSO BE INTERESTED IN

Publications
Readability User Testing of Package Information Leaflets (PIL) in EAEU
Read More
Publications
Remote clinical trial monitoring
Read More
Publications
Post-authorization studies of drug safety in Russia
Read More

RUBRICS

Registration strategy and Сonsulting

Clinical trials

Registration

Post-authorization clinical studies

Pharmacovigilance

LATEST PUBLICATIONS

  • Corrections to clinical trial documents due to COVID-19. Russian experience.
  • WHAT IS BIOEQUIVALENCE
  • THE VOLUME OF RUSSIAN PHARMACEUTICAL MARKET 2016-2019

Tags

bioequivalenceClinical trials in the CISfeasibilitymonitoringRadiopharmaceuticals

CONTACT

1 + 3 = ?

This contact form is deactivated because you refused to accept Google reCaptcha service which is necessary to validate any messages sent by the form.

PRIVACY

Use of this site constitutes your consent to our Privacy Policy.


SOCIAL RESPONSIBILITY

X7 Research’s primary responsibility is to help our clients in bringing medicines & products to the market efficiently and safely.

The Best CRO for Clinical Trials | Full-service Global CRO — X7 Research

The Best CRO in Pharma | Clinical Research Organisation — X7 Research

The Best Contract Research Organisation (CRO) | Trusted CRO — X7 Research

The Best Clinical Research Organisation (CRO): Full Service CRO | X7 Research

The Best CRO in Research | Trusted CRO for Your Trail — X7 Research

The Best Clinical Trial Company | Global Full-service CRO - X7 Research

The Best Pharma CROs: Clinical Trials for Drugs | X7 Research

The Best CROs Company: Clinical Trials with Global CRO — X7 Research

The Best Pre-clinical CRO: Safety Assessment With X7 Research

The Best Clinical Development | Trusted CRO for Your Product: X7 Research

The Best Biostatistical Consulting: Statistical Services | X7 Research

The Best Pharmacovigilance Consulting Services | CRO — X7 Research

Feasibility in Clinical Trials: What is a Feasibility in Clinical Trials?

Clinical Study Trials: What are Clinical Study Trials?

Category
Strategy and consulting
Clinical trials
Registration
Post-authorization clinical studies
Pharmacovigilance

Registration strategy and Сonsulting
Registration strategy development
Budgeting
Study feasibility
Vendor selection
Data search and analysis

Clinical trials
Development of medical documentation and biostatistics
Monitoring
Data management
Patient home visits
Bioequivalence study
Therapeutic equivalence studies

Registration
Audit of the registration dossier
Dossier eaeu
Conversion of registration dossier into xml format
Pil readability user testing
Turnkey registration

Post-authorization clinical studies
Phase iv studies
Non interventional studies
Investigator initiated studies
Post authorisation safety study
Marketing research

Pharmacovigilance
Building a pharmacovigilance system
Safety in clinical trials
Pharmacovigilance audit
Pharmacovigilance contact person

Blog
Contacts

© Copyright 2010-2023 - X7 Research. All rights reserved.
10 popular drugs that are about to lose their patents EMA implicates anonymous denunciations procedure
Scroll to top