by Thomas Meek

LONDON, Oct 18 (APM) - Pfizer and Celltrion's biosimilar version of Janssen's Remicade (infliximab) demonstrated it is not inferior to the originator drug across its range of indications, according to real-world data presented on Tuesday.

Results of the NOR-SWITCH study, presented at the United European Gastroenterology conference in Vienna, Austria, showed great similarity between outcomes on Remicade and Remsima, a biosimilar version of the product developed by Celltrion approved in Europe in 2013, after patients were switched to the biosimilar (APMMA 34689).

Remsima is an identical drug to the biosimilar Inflectra, developed by Hospira. Pfizer obtained rights to Inflectra when it acquired Hospira in 2015 and is in a partnership with Celltrion on biosimilar infliximab.

Funded by the Norwegian government, the 52-week Phase IV trial involved 481 patients diagnosed with Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis and chronic plaque psoriasis and all originally on stable treatments with Remicade. Of the patients, 241 remained on Remicade and 240 were switched to Remsima.

Researchers said changes in the generic disease variables and disease-specific composite measures were similar in both arms, while the incidence of anti-drug antibodies detected during the study was 17 (7.1%) and 19 (7.9%) in the Remicade and biosimilar patients respectively.

Data showed disease worsening in all conditions in 53 patients (26.2%) in the Remicade arm and 61 patients (29.6%) in the Remsima arm. The gap was the biggest in Crohn's disease, where 14 patients (21.2%) on Remicade saw disease worsening compared to 23 (36.5%) on the biosimilar. All other conditions had relatively equal levels of disease worsening.

In a telephone interview with APM, Pfizer's Javier Coindreau, vice president global medical affairs - biosimilars, said there were "no surprises" in the results of the study, which he said was the first independent clinical trial evaluating the switching of an originator product to its biosimilar.

He said the data produced in the study support switching from the originator monoclonal antibody to its biosimilar, as Remsima maintained the expectations of efficacy and safety.

"There is no worsening of the patient," said Coindreau. "There is only the worsening that is expected. For each one of the indications there was a pre-defined definition of worsening and the great result of this study is there is no worsening of those patients who switched".

Coindreau said he expects the results of the study to help increase confidence in switching patients from Remicade to the cheaper Inflectra - an important issue considering the potential savings that could be made by cash-strapped healthcare systems in Europe.

Norway is among the countries leading the way in this area, with IMS Health saying in June this year that biosimilar infliximab had a market share of 94%, and Denmark and Poland also nearing complete switch (APMMA 48344). However, uptake is much lower in other countries, with biosimilar infliximab holding a market share of less than 30% in the UK, Germany, Italy, Spain and France, and the results of NOR-SWITCH could influence acceptance in these areas.

"Of course the level of confidence that exists will be strengthened by results of clinical trials like this. So I think the physicians will feel more confident about the issue of biosimilars, in this case Inflectra infliximab," said Coindreau.

In an emailed statement on NOR-SWITCH, The Global Alliance for Patient Access (GAFPA) urged healthcare policymakers not to take the results as a reason to switch all stable patients on biological drugs to biosimilars to save money.

GAFPA member David Charles said: "GAFPA is concerned that policymakers may use the findings of the 'NOR-SWITCH' study as a 'carte blanche' to switch stable patients from a biologic medicine to a biosimilar for non-medical and purely financial reasons."

"It is imperative that decisions about a patient's treatment always be made by the physician and his or her patient, and that the patient is given meaningful information in order to provide clear consent. Any switch without informed consent places at risk the accurate reporting of adverse reactions and jeopardises the patient-physician relationship."

Coindreau responded to these comments by saying the NOR-SWITCH trial should only apply to switching between Remicade and Inflectra infliximab.

"The results of switching trials cannot be extrapolated to other biosimilars or other compounds. Each biosimilar needs to have its own evidence in order to make clinical and regulatory and reimbursement decisions. That's Pfizer's position."

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