Webinar Recap: Generics and Biosimilars in MS Treatment

On 20 November 2024, MS Nurse PRO hosted an engaging webinar, Generics and Biosimilars in the Treatment of Multiple Sclerosis (MS), featuring expert speakers Piet Eelen and Amy Perrin Ross.

The session offered valuable insights into the role of generics and biosimilars in MS care, with a focus on the nursing perspective.

Key Insights from Amy’s Presentation

• Definition and characteristics of biosimilars:
  Biosimilars are highly similar to reference biologics, with no clinically meaningful differences in terms of quality, safety, or efficacy.
• Comparison with branded products:
  Biosimilars share the same living sources, route of administration, strength, dosage, and treatment benefits as branded biologics.
• Distinction between generics and biosimilars:
  Unlike generics, which are chemically synthesized, biosimilars are derived from living organisms and involve more complex manufacturing and regulatory processes.
• Cost implications in MS treatment:
  MS is among one of the most expensive chronic conditions to treat, with lifetime costs averaging around $5 million. Biosimilars offer a cost-effective alternative due to their abbreviated clinical trial programmes.
• Approval and regulatory requirements:
  Approval of biosimilars is based on the "totality of evidence," including structural, functional, pharmacokinetic, and pharmacodynamic equivalence studies.
• Interchangeability:
  Not all biosimilars are interchangeable. Additional regulatory requirements must be met to classify a biosimilar as interchangeable, allowing substitution without prescriber intervention.
• Benefits vs. risks:
  While biosimilars provide cost savings and access benefits, careful evaluation of safety, efficacy, and immunogenicity in sensitive populations is essential.
• Impact on care of people with MS:
  The adoption of biosimilars could reduce treatment costs, improving accessibility while maintaining treatment efficacy.
  

Key Insights from Piet Eelen's Presentation:

• Evolving role of MS nurses:
  The increasing complexity of disease-modifying therapies (DMTs) requires MS nurses to adapt their roles, emphasising patient education and communication.
• Treatment landscape:
  Over the past 30 years, MS treatments have advanced significantly, with the introduction of high-efficacy therapies, oral treatments, and biosimilars, adding complexity to patient management.
• Practical management strategies:
  MS nurses are pivotal in managing therapy switches, educating patients about their disease and treatment options, and fostering shared decision-making to improve adherence and outcomes.
• Nocebo effect in biosimilars:
  Negative expectations about biosimilars can reduce their acceptance and clinical benefits. Nurses can counteract this by delivering balanced information, framing positive attributes, and empowering patients.
• Consensus recommendations for follow-on DMTs:
  Recommendations include comprehensive education, timely reporting, ongoing pharmacovigilance, and strategies to minimise nocebo effects, promoting evidence-based decision-making and patient empowerment.
• Tools for nurses:
  Resources like pocket guides, lexicons, and infographics can support nurses in explaining treatment options effectively to patients.
  

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