As more biosimilars become available globally, clinicians are eager to understand: How does switching between biological medicines affect patients? On June 13, the Global Alliance for Patient Access hosted an international group of physicians, researchers and patient advocates in London to take a closer look at one source of clinical data on switching – the NORSWITCH study.
The NORSWITCH Study
Conducted in Norway, NORSWITCH is a randomized, double-blind, phase 4 study. It’s designed to assess the safety and efficacy of a single switch from innovator infliximab to a biosimilar infliximab. The study seeks to determine non-inferiority – whether the biosimilar’s results are no worse than the biologic’s. It differs from trials designed to establish interchangeability, which typically employ multiple switches between the biosimilar and the biologic.
NORSWITCH includes patients with:
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
- Ulcerative colitis
- Crohn’s disease
- Chronic plaque psoriasis.
The study has gained significant attention in recent months – for both its design and its potential to influence policies that govern biological medicine.
GAfPA Meeting: Switching, Safety & Pharmacovigilance
To explore the meaning and impact of forthcoming NORSWITCH data, GAfPA welcomed representatives from dermatology, rheumatology, gastroenterology, neurology, pharmacology, and patient advocacy. Guest speakers included NORSWITCH clinical coordinators Guro Løvik Goll, MD, PhD, and Kristin K Jørgensen, MD, PhD. Attendees from Spain, Germany, Italy, Poland, the United Kingdom, the United States and Latin America brought a global perspective to the dialogue.
Key policy issues included:
- The importance of distinguishable names for track and trace
- The need for registries to collect data on biologic and biosimilar use to evaluate the safety of switching
- The importance of educating patients and patient groups on key policy issues so they, in turn, can educate policymakers.
NORSWITCH coordinators acknowledged several of the study’s limitations, such as whether the number of patients enrolled allows coordinators to truly evaluate the effect of the switch. They also conceded the challenge of combining data from all six of the disease states tested, rather than sub-grouping patients and their data.
The group was enthusiastic, however, about the significant biobank of serum samples collected methodically for every patient, as these endpoints can help establish whether the switch is associated with loss of efficacy. Clinical coordinators also explained that the study’s data are likely to “build confidence in biosimilars.”