Theradiag, Biogen Partner to Provide Lisa Tracker Kits for Flixabi Monitoring

In vitro diagnostics and theranostics company Theradiag is partnering with the U.S. biotech company Biogen to provide Lisa Tracker kits for monitoring treatment with Flixabi, a biosimilar of Remicade (infliximab).

Like Remicade, which is marketed by Janssen, Biogen’s Flixabi is indicated for the treatment of autoimmune diseases and chronic inflammatory conditions such as ankylosing spondylitis.

Anti-TNFαs (TNF is tumor necrosis factor) are therapeutic agents prescribed to treat more than 50,000 patients with chronic inflammatory conditions. These agents bind to TNFα, blocking its action. TNFα is responsible for the promotion of an inflammatory state.

Infliximab is an anti-TNFα biologic recommended for the treatment of inflammatory diseases.

Studies have shown that anti-drug neutralizing antibodies (ADAb) can appear in patients who develop therapeutic resistance to treatment with anti-TNFα. The presence of such antibodies could be a sign of potential clinical deterioration.

Theradiag’s Lisa Tracker kits are the first CE (Conformité Européenne) marked kits for the assessment of TNFα levels and the presence of ADAb. The kit can measure three specific parameters within three hours after analyzing a serum sample: circulating TNFα, a marker of the inflammatory process; prescribed anti-TNFα levels such as Flixabi; and the presence of ADAbs, which could indicate a drop in the therapy’s effectiveness.

These kits allow the monitoring of the patient’s condition over time through these three parameters, offering the opportunity for clinicians to anticipate, optimize, and improve the management of patient treatment.

“This agreement with Biogen advances our strategy of developing together with pharmaceutical groups and provides further evidence of their interest in our monitoring kits. It will also enable us to continue Lisa Tracker’s commercial development biotherapy monitoring, especially in France,” Michel Finance, Theradiag’s chief executive officer, said in a press release.

Since 2016, Biogen has marketed two biosimilar drugs in France, including Flixabi. Now, thanks to this agreement, the company will supply Lisa Tracker monitoring kits to optimize the treatment of patients receiving Flixabi in France and other European countries.

According to the agreement, Theradiag will be Biogen’s preferred supplier of Lisa Tracker.