Date: 2017-12-13
Type of information: Granting of a Market Authorisation in the US
Product name: Ixifi ™ - PF-06438179 (biosimilar version of Remicade® (infliximab)
Compound: (infliximab-qbtx)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Dermatological diseases - Digestive diseases - Rheumat
Action mechanism:
- monoclonal antibody/biosimilar. Infliximab is a tumor necrosis factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis (RA) and psoriasis.
- In February 2016, Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of Ixifi ™ - PF-06438179 in the 28 EU member states, as well as three of the four member states of the European Free Trade Association (EFTA) (Iceland, Liechtenstein and Norway) that form the European Economic Area (EEA). Under the terms of the divestment, Pfizer retains commercialization and manufacturing rights to PF-06438179 in countries outside the EEA.
Company: Pfizer (USA - NY)
Disease:
- rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis
Latest news:
- • On December 13, 2017, Pfizer announced that the FDA has approved Ixifi™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product (rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis).
- This approval follows the acceptance of the Ixifi™Biologics License Application in April 2017 and is based on the totality of evidence demonstrating a high degree of similarity to the reference product, including the REFLECTIONS B537-02 study in patients with moderate to severe active rheumatoid arthritis.
- The Phase 3, multi-national, randomized, double blind, two-arm, parallel group study evaluated the safety, efficacy, and immunogenicity of Ixifi™ versus Remicade administered intravenously in combination with methotrexate to treat patients with moderate to severely active RA who have had an inadequate response to methotrexate therapy.2 The study met its primary endpoint of ACR20 response (?20% improvement by American College of Rheumatology criteria) at Week 14, and was supported by data at week 30.
- Ixifi™is the third FDA-approved biosimilar to U.S.-licensed Remicade®. Inflectra™ has been approved in April 2016. The biosimilar has been developed by Celltrion and Hospira, which is now a part of Pfizer. Renflexis™ (infliximab-abda) has been approved in April 2017. The drug has been developed by Merck&Co and Samsung Bioepis.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-12-13
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
