Swiss IBD Group's Position Statement on Biosimilars Discourages Pharmacy-Level Substitution and Nonmedical Switching

The Inflammatory Bowel Disease Net, an official working group of the Swiss Society of Gastroenterology, has issued a new position statement on the use of biosimilars in treating inflammatory bowel disease (IBD).

The position statement explains that the Swiss regulatory body, Swissmedic, requires that biosimilars be “sufficiently similar” in their structure, activity, efficacy, safety, and immunogenicity, much like the FDA’s requirement that there be no clinically meaningful differences between biosimilars and their references.

The statement goes on to say that biosimilars and biologics should be prescribed by brand name, not by international nonproprietary name (INN), because biosimilars and their reference products share INNs. Using brand names will help with postmarketing studies and monitoring programs, says the group, and global harmonization on nomenclature is desirable.

With respect to interchangeability of biosimilars with their reference products, the statement indicates that the infliximab biosimilars Inflectra and Remsima, which are the same product (CT-P13) marketed under different names, can be interchanged. The group cautions that interchanging the reference infliximab, Remicade, with biosimilars will require close monitoring for efficacy and safety.

The group strongly discourages pharmacy-level substitution, in keeping with Swissmedic’s advice that the decision to interchange products be left with prescribing physicians. “There is general concern that automatic substitution might lead to dispensing mistakes that might potentially harm patients, especially when interchangeability has not directly been demonstrated in many specific clinical settings of a given disease,” say the position statement’s authors, who add that concerns exist about pharmacovigilance, as pharmacists in Switzerland are not required to track batches of products, while prescribers must track such data.

Despite its cautions about interchangeability and substitution, the position does note that the available data on nonmedical switches from Remicade to CT-P13 do not suggest that there are adverse impacts related to switching. It also notes that immunogenicity and the frequency of adverse events have not been shown to differ between patients treated with reference or biosimilar infliximab.

However, the position also points out that, in Switzerland, unlike many other countries, healthcare providers “are currently the only beneficiaries of switching a patient from a reference product to a less-expensive biosimilar,” and patients do not see any financial benefit from undertaking a nonmedical switch. As such, nonmedical switches should be avoided, says the group.

Reference

Burri E, Juillerat P, Maillard MH, et al. Position statement on the use of biosimilars in inflammatory bowel disease. Swiss Med Wkly. 2019;149:w20148. doi: 10.4414/smw.2019.20148.