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.
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:
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.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Physician and Patient Perspectives After Starting or Switching to Amgevita in IBD
March 23rd 2024A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.
Biosimilars Gastroenterology Roundup for January 2024—Podcast Edition
February 4th 2024On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.
Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake
March 18th 2024Government policies, including those related to prescribing incentives and interchangeability, need to be reworked to encourage biosimilar adoption and create meaningful savings for health systems, according to speakers at a recent webinar.
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.