By ParadigMS Foundation
On June 11th 2024, FROM 3:30 TO 4:30 PM we had the pleasure of running a highly insightful live webinar on the use of generics, biosimilars, and NBCDs for Multiple Sclerosis, led by two outstanding experts, Professor Celia Oreja-Guevara and Professor Thomas Bergen.
Who attended:
Neurologists, opthamologists, radiologists and other HCP as well as industry representatives from more than 30 countries.
Key Takeaways:
- In Europe, there are robust regulatory processes specific for generics, biosimilars and follow-on NBCDs to ensure that in Europe these agents can be considered equally effective and safe as the originator Disease-Modifying Therapies (DMT).
- Concerns exist about the approval of such products in resource-limited settings where regulatory processes and post-marketing pharmacovigilance practices are less robust than in Europe. As these agents become more widely available, it is the responsibility of physicians caring for PwMS to familiarise themselves with the regulatory environment.
- Generics, including biosimilars and NBCDs, are pharmaceutical products designed to be similar to reference medicines but may have molecular differences due to their complex nature
- Biosimilars undergo rigorous comparability assessments to demonstrate similarity in quality, safety, efficacy, and immunogenicity to the reference product, aiming to show no clinically meaningful differences.
- Generics play a crucial role in providing cost-effective alternatives while ensuring comparable therapeutic outcomes to their reference products.
If you wish to see the recording it will be soon available:
