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 on the the definition and regulatory framework:

• 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 on MS nurses responsibilities:

• 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.

Meet the speakers

Amy Perrin Ross
APN, MSN, CNRN, MSCN,
Loyola University Medical Center (USA)

Amy Perrin Ross is the Neuroscience Program Coordinator at Loyola University Medical Center in Maywood, Illinois. She is the Coordinator of the MS Center at Loyola. 

Ms. Ross earned her undergraduate and graduate degrees from Loyola University in Chicago, Illinois. She has also completed coursework for her doctoral degree at the University of Illinois Medical Center. She is board certified as a Neuroscience Nurse by the American Board of Neuroscience Nursing, and as a Multiple Sclerosis Nurse by the Multiple Sclerosis Nursing International Certification Board.

Ms. Ross is an active participant in a variety of medical societies, including the American Association of Neuroscience Nurses, the American Association of Critical Care Nurses, the Multiple Sclerosis Society, the Multiple Sclerosis Association of America, and the International Organization of Multiple Sclerosis Nurses and the Consortium of MS Centers. She is a Clinical Reviewer for the International Journal of MS Care. Her work has been published in numerous journals, including Multiple Sclerosis, Frontiers in Neurology, the International Journal of MS Care, the International Journal of Clinical Practice, Neurology, Practical Neurology and the Journal of Neuroscience Nursing. Ms. Ross has participated in more than 40 research studies and has been invited to speak before numerous national and international meetings and conferences. She has been honored for her work in the field, receiving the 2015 June Halper Award of Excellence in International MS Nursing, recognizing her for leadership and creativity in the care of people with MS and their families.  

Piet Eelen
RN, MSc, National MS Center,
Belgium

Piet Eelen is a Clinical Nurse Specialist Multiple Sclerosis working in the National Multiple Sclerosis Center (NMSC) of Melsbroek, Belgium. He has a post-bachelor degree in Rehabilitation and Continence Nursing. From 1990 until 2011 he worked as a head nurse of a rehabilitation ward. Since 2012 he works as a clinical nurse specialist guiding and supporting persons with MS in his clinical practice, with a special focus on chronic disease management and lifestyle factors in MS.

He organizes courses for nurses to stimulate development and education, in the NMSC and in Belgium. He participates and collaborates with national and international healthcare associations. He is an invited speaker and member of advisory boards organized by pharma companies. Finally he participates and organizes research projects in MS in the NMSC. Since 2012 he is the president of the Belgian Association of MS-Nurses. Since 2020 he is the chair of the syllabus committee of MS Nurse PRO.

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