WASHINGTON, DC — The success of the infliximab biosimilar in two European studies could increase uptake of the agent in the United States, experts said here at the American College of Rheumatology 2016 Annual Meeting.
No red flags were raised in the Norwegian and Danish studies when patients switched from the infliximab originator Remicade (Janssen) to the biosimilar Remsima, known as Inflectra in the United States (Celltrion/Pfizer).
"Given that the FDA has approved the infliximab biosimilar in the United States, these data are reassuring," said Kelly Weselman, MD, from the WellStar Health System in Smyrna, Georgia.
"It's an important issue because so many policy decisions will be made that will effect clinicians in terms of being forced to use biosimilars," she told Medscape Medical News.
The Norwegian NOR-SWITCH noninferiority randomized controlled trial involved 481 patients with a mix of diagnoses, including spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and chronic plaque psoriasis.
Patients who had been on stable treatment with infliximab for at least 6 months were randomized to continue or to switch to the biosimilar.
At 52 weeks, disease had worsened in 26.2% of the originator group and 29.6% of the biosimilar group.
"This is within the predefined noninferiority margin," said lead investigator Tore Kvien, MD, from Diakonhjemmet Hospital in Oslo, Norway.
"There was some variation between the different diseases, but the study was not powered to show noninferiority in individual diseases," he told Medscape Medical News.
There were no differences between groups in the secondary end points of remission rate, change in composite score, immunogenicity, or safety.
Results from the larger observational Danish trial were "extremely similar," said investigator Merete Lund Hetland, MD, from Copenhagen University Hospital in Hvidovre, Denmark.
Dr Hetland and her colleagues used the DANBIO registry to identify 802 patients — 279 with spondyloarthritis, 403 with rheumatoid arthritis, and 120 with psoriatic arthritis — who received the infliximab biosimilar as part of a nationwide mandated switch.
The team compared disease activity and flares 3 months before and 3 months after the switch and found no significant changes for any of the three diseases.
Adherence rates at 1 year were similar for each disease, and the 16% nonadherence rate was similar to historic nonadherence rates with the infliximab originator.
Table. Reasons for Nonadherence to the Biosimilar
| Reasons | Percent of Patients |
| Lack of effect | 54 |
| Adverse events | 28 |
| Remission | 4 |
| Cancer | 4 |
| Death | 2 |
| Several | 2 |
| Other | 6 |
| Unknown | 1 |
"It's amazing. From withdrawal rates, to efficacy, to flares, our study and NOR-SWITCH showed similar things. I think they complement each other very well," Dr Hetland said.
"Their findings are very consistent with ours and provide additional support for efficacy, safety, and immunogenicity issues related to switching," Dr Kvien added.
But both researchers cautioned that the results for the infliximab biosimilar should not be extrapolated to biosimilars for etanercept or adalimumab.
"They are completely different molecules and we cannot know it will be the same story," said Dr Hetland.
In Denmark, switches to the infliximab biosimilar led to an 80% cost reduction. In Norway, the cost reduction was about 70%.
"The idea of biosimilars is that they are not better or worse, but they're less expensive," said Dr Kvien. "If we save costs, we will have more resources for new innovative therapies. If drugs are cheaper, more patients will have access to good therapies."
"This is good news for patients," added Dr Hetland. "I hope this will make biologic treatments available to more people."
As the infliximab biosimilar enters the market in the United States, it is expected that there will also be cost savings, Dr Weselman said.
But cost aside, "physicians and patients must be confident in the safety and efficacy of these new products," she explained. "These findings support the safety and efficacy of this particular biosimilar agent."
NOR-SWITCH was funded by the Norwegian government. Dr Weselman reports receiving consulting fees from UBC. Dr Kvien reports financial relationships with Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Hospira, Merck-Serono, Novartis, Orion Pharma, Prizer, Sandoz, and UCB. Dr Hetland reports receiving research grants from AbbVie, BMS, MSD, Roche, Pfizer, UCB, and Crescendo.
American College of Rheumatology (ACR) 2016 Annual Meeting: Abstract 951, presented November 13, 2016; abstract 19L, presented November 15, 2016.
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Cite this: European Studies of Infliximab Biosimilar Reassuring - Medscape - Nov 17, 2016.
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