Celltrion presents data at US conference

By Gareth Macdonald contact

- Last updated on GMT

Celltrion manufactures a biosimilar to Janssen's Remicade
Celltrion manufactures a biosimilar to Janssen's Remicade

Related tags: Rheumatoid arthritis

Celltrion’s Remsima campaign rolled into the US this week with another presentation of data showing that the Remicade (Infliximab) biosimilar is equivalent to the reference drug.

The South Korean drugmaker’s attendance at Digestive Diseases Week (DDW) in Washington DC was similar – all puns intended – to its attendance at the European Crohn´s and Colitis Organisation (ECCO) event in Barcelona in February.

Celltrion hosted a satellite symposium where independent researchers presented data underlining that Remsima (Infliximab) is as safe and effective as treating autoimmune diseases as the reference product.

As in Barcelona, the Celltrion-hosted symposium in Washington featured a presentation from University of Oslo researcher Jørgen Jahnsen who told attendees the efficacy and tolerability of Remsima in IBD “appears to be the same as the reference medicinal product​.”

Cost saving

Prof Jahnsen also said Remsima offers “potential budget savings​” which was a point also stressed by Celltrion when Biopharma-Reporter.com asked for more information.

The firm told us “in Norway, Orion Pharma has offered a 72% price reduction for the Remsima, a 69% lower cost than for the RMP.

The price of Remsima in other markets is determined by Celltrion Healthcare’s partner companies according to their own pricing and marketing strategy​” the firm added.

These comments fit with what Celltrion told us in February, when is argued that Governments and patients across would save money as a result of Remsima​, and also were in keeping with predictions made by Merck & Co​, which sells Remicade in Europe.

US review

Celltrion already sells Remsima in many European markets in partnership with various local distributors​.

The drug is not approved in the US, although Celltrion and Hospira – which sells the drug under license as Inflectra​ in a number of European markets – filed it for US Food and Drug Administration assessment last August​.

The US agency was due to meet to discuss Remsima – filed as CT-P13 – in March, however, it delayed the meeting in February and asked Celltrion for additional information.

When asked about the status of the application Celltrion told us the “Biologics License Applications for Remsima is currently under review by the FDA.

The timing of the FDA Arthritis Advisory Committee will be determined by the FDA but it is anticipated that it will be scheduled in 2015​.”

Related topics: Markets & Regulations, Biosimilars

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