Eye on Pharma: Nichi-Iko Seeks Interchangeable Designation for NI-071

Last month, Tokyo-based biosimilar developer Nichi-Iko announced that its biosimilar infliximab, NI-071 had been approved by Japan’s Ministry of Labor, Health, and Welfare. The biosimilar infliximab will be jointly marketed in Japan by ZERIA Pharmaceutical Co.

The biosimilar developer has also begun a phase 3 clinical program in the United States with an eye toward eventual FDA approval for its biosimilar; the RADIANCE trial—conducted by Nichi-Iko’s US subsidiary, Sagent Pharmaceuticals—will evaluate the similarity of NI-071 and the US-approved originator infliximab (Remicade) in terms of safety and efficacy in patients with rheumatoid arthritis who have not responded adequately to methotrexate.

Nichi-Iko also disclosed that it is currently engaged in consultations with the FDA concerning the demonstration of interchangeability of the proposed biosimilar with the reference Remicade. The United States is alone among regulatory bodies in requiring an FDA designation of interchangeability for a biosimilar before it can be substituted for its reference at the pharmacy level. The fact that the FDA has not yet published its final interchangeability guidance poses a distinct challenge to biosimilar developers seeking the additional level of regulatory clearance. However, in July, FDA officials signaled that the interchangeable biosimilars could begin to gain approval within the next 2 years.

If Nichi-Iko is successful in bringing an infliximab biosimilar to the US marketplace, NI-071 would join biosimilars made by Pfizer (Inflectra) and Merck (Renflexis) in competing with Remicade for a place on insurers’ formularies. Analysts predict that competition among biosimilar infliximab therapies will serve as a bellwether for how successful the US biosimilars market could be in the coming years.

So far, Johnson and Johnson has largely maintained its market share for infliximab, though biosimilar challengers question its methods; in September, Pfizer filed a district court lawsuit against Johnson and Johnson for allegedly engaging in exclusionary formulary contracting and anti-competitive practices that have effectively denied patients access to biosimilars.