European Medicines Agency Confirms Biosimilar Medicines Can Be Interchanged Safely

-

A biosimilar medicine is one that shows a high level of similarity to an existing approved biological medicine, known as the "reference product." Interchangeability refers to the practice of substituting one medicine with another, as long as the therapeutic effect remains consistent. In this case, it means replacing a reference product with a biosimilar that will provide the same clinical outcomes.

Biosimilar Medicines


The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement, supported by an analysis of over a million patient-treatment years with no safety concerns raised. The statement confirms that once a biosimilar is approved in the EU, it can be substituted for the reference product or replaced by another biosimilar of the same reference product. Although several EU member states already allow such interchangeability, the joint statement aims to harmonize and standardize this practice across the EU.

READ THE FULL BLOG 

Know more about our Regulatory Services in USA

To get the daily updates, follow us on:

Facebook — https://www.facebook.com/DDReg

LinkedIn — https://www.linkedin.com/company/ddregpharma/

Twitter — https://x.com/DDRegPharma

Instagram  — https://www.instagram.com/ddreg.pharma/

Comments

Post a Comment

Popular posts from this blog

What is an IMPD? Understanding Its Role in Clinical Trials and Drug Development

-
Image
What is an IMPD? Understanding Its Role in Clinical Trials and Drug Development An Investigational Medicinal Product Dossier (IMPD) is a key document in the clinical trial and drug development process, specifically for drugs or biologics undergoing testing in human clinical trials within the European Union (EU). It serves as a comprehensive report detailing the quality, manufacture, and control of the investigational product. The IMPD is a crucial regulatory submission required by the European Medicines Agency (EMA) or national regulatory bodies to evaluate whether a clinical trial can proceed. Key Components of an IMPD The IMPD includes several sections, providing information that ensures the safety and efficacy of the investigational product. These sections typically cover: Product Description and Composition: The IMPD provides detailed information about the investigational product, including its chemical composition, formulation, and dosage forms. Manufacturing and Control: This...
Read more

Gap Analysis and Compliance Remediation Services

-
Image
Ensuring Regulatory Compliance: A Step-by-Step Guide to Gap Analysis and Remediation In the fast-paced world of the pharmaceutical industry, following FDA rules and standards is key. It's a complex task, but being proactive can help companies avoid risks and keep their products top-notch. This guide will show you how to do a gap analysis and fix any issues, helping your business stay safe and respected. For the pharmaceutical industry, following rules is essential. A detailed gap analysis helps find where your company might not meet standards. This step is important for fixing problems and making sure your company is in line with the rules. Key Takeaways Regulatory compliance is crucial for pharmaceutical companies to ensure product quality, reduce risks, and maintain a positive reputation. Gap analysis is a vital process that identifies areas where an organization's practices fall short of regulatory requirements. Effective remediation strategies address the identified gaps ...
Read more

What Are Regulatory Intelligence and Strategic Advisory Services?

-
Image
  What Are Regulatory Intelligence and Strategic Advisory Services? Regulatory Intelligence (RI) and Strategic Advisory Services play a pivotal role in guiding companies through the complex landscape of regulatory compliance and market access in the healthcare and pharmaceutical industries. These services provide businesses with the insights and strategies needed to navigate ever-evolving regulatory requirements and ensure long-term success. Regulatory Intelligence involves the collection, analysis, and interpretation of regulatory information from global, regional, and local authorities. This includes staying updated on legislation, guidelines, and regulatory trends affecting specific markets or products. The primary goal is to anticipate changes in regulations and adapt compliance strategies proactively. RI also provides competitive insights by analyzing how similar companies or products address regulatory challenges, helping businesses make informed decisions. Strategic Adviso...
Read more