Spanish Provider Group Revises Its Position on Biosimilars

This week, the Spanish Society of Digestive Pathology (SEPD) became the most recent organization to announce an updated position statement on the use of biosimilars.

Published in The Spanish Journal of Gastroenterology,¹ the new position statement explains the organization's current thinking on biosimilar usage, extrapolation, and switching. SEPD came to these viewpoints based on the data found by the NOR-SWITCH study, and the new views of the European Crohn’s and Colitis Organization (ECCO) on biosimilars.

SEPD’s new position holds that that:

• A biosimilar is intended to provide an action equivalent to its reference product and requires a thorough testing process.
• The extrapolation of indications is reasonable if the European Medicines Agency considers extrapolation based on previous clinical trials.
• The label of the biosimilar should clearly identify the name of the biosimilar.
• Based on data published, biosimilar infliximab, CT-P13, is safe and effective in inflammatory bowel disease.
• The use of a biosimilar should involve a discussion between physicians and patients.
• The organization supports the development of biosimilar drugs as well as their approval by regulatory agencies.

In addition to SEPD, the American Society of Clinical Oncology (ASCO) also updated its biosimilar position statement in recent days. ASCO’s statement notes that, in terms of the safety and efficacy of biosimilars, postmarket evidence will be key to demonstrating the value of biosimilars to stakeholders. In order to make informed treatment choices, ASCO also emphasizes that prescribers should be consulted before a pharmacist substitutes an interchangeable biosimilar for a reference product. In addition, ASCO discussed the importance of healthcare stakeholders to be able to easily identify products to ensure that patients receive the correct therapy.

In order to limit patient’s out-of-pocket costs, ASCO states that, if a biosimilar is not designated as interchangeable, it could be subject to policies that cover single-source and non-preferred products. “Reasonable compensation, fair and medically appropriate coverage, and transparency of cost will serve to ensure a true value benefit to patients and society and promote access to new and innovative therapies,” notes ASCO.

Reference

1. Arguelles F, Hinojosa J, Mendoza I. Update of the SEPD position statement on the use of biosimilars for inflammatory bowel disease. Published online March 12, 2018. Rev Esp Enferm Dig. doi: 10.17235/reed.2018.5456/2018.