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.
TORONTO (PRWEB)
November 11, 2020
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.
Join Gabriela Marton, Regulatory Affairs Director, Quality Director, Arriello in a live webinar on Tuesday, November 24, 2020 at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Biosimilars in Europe: Pricing, Interchangeability and Policy.
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