Biological medicines represent a major advance in the treatment of serious pathological conditions such as cancer, neurodegenerative and autoimmune diseases. And biosimilars, as their cost-effective alternatives, improve patient access to modern therapy.
The European Medicines Agency (EMA) has been a pioneer in issuing scientific guidelines related to the regulatory requirements for the approval of biosimilars, with European National Authorities following similar efforts to enable access to these medicines.
After biosimilarity is demonstrated and products are authorized, manufacturers still struggle to access markets and ensure patients have access to them. And there are many reasons why, especially around pricing and policy at many different levels, that this is such a complex and interesting process.
Whilst the majority of EU countries have succeeded in achieving widespread acceptance by payers, providers and patients of biosimilars, these positive efforts have also revealed new challenges and risks.
The experience with biosimilars acquired to date has helped to strengthen trust in them. They are becoming more widely used by clinicians, and there is evidence that they can be used safely and effectively in their approved indications. In the near future, there is expected to be an avalanche of new biosimilars coming onto the market as the patents of innovator products expire.
It is therefore essential to discuss the regulatory challenges and share current experiences around biosimilars in readiness, which the panelists will do in this webinar, in order to spread both awareness and knowledge about them amongst all stakeholders.
Gabriela Marton, Regulatory Affairs Director, Quality Director, Arriello
Gabriela Marton is the Regulatory Affairs Director and Quality Director at Arriello. She leads all regulatory affairs functions, developing robust and efficient market access and post-marketing strategies to support pharmaceutical companies’ business needs.
She has over 14 years of experience in regulatory affairs and compliance within the pharmaceutical and food supplements sectors. Previously, she was an independent regulatory consultant, and has held several positions in regulatory affairs and compliance in various pharmaceutical companies, one of which is GSK, where she started her regulatory career and has worked for over 9 years.
Who Should Attend?
- Regulatory Affairs Heads, Directors, Managers and Specialists
- Market Access Heads, Directors, Managers and Specialists
- Business Development Functions with an Interest in Biosimilars
- Anyone with an Interest in Biosimilars
What You Will Learn
In this webinar, participants will learn about:
- Patent and market exclusivity status
- Interchangeability within the current EU framework
- Positive changes and challenges of biosimilars with EU policy
Arriello has been a leading provider of risk management and compliance services to the Life Sciences sector since 2008. These include Market Consultancy, Global Regulatory Affairs strategy and implementation, Full and Local Pharmacovigilance solutions, Clinical Drug Safety, and Quality and Compliance auditing and systems.
Our brief is simple: to make the process from development to market faster, better and smarter.
Headquartered in Ireland, with European operations in Central Europe, our technical team has a combined experience of over 130 years working across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa. We currently operate in 143 countries with the ability to expand this as required.
With our in-house expertise, vendor network, ISO 9001 certification, years of experience and satisfied clients, including global Originators, Biotech’s, Generics and CRO’s, you can be confident in our ability to deliver as a trusted partner.