FDA approves new Pfizer biosimilar

PfizerPfizer Inc. (NYSE:PFE) announced that the United States (U.S.) Food and Drug Administration (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. (1)

The FDA has approved IXIFI as a treatment for patients with rheumatoid arthritis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.(1)

FDA 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 RA(2). 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.(3)

Pfizer has a portfolio of three marketed biosimilar medicines outside the U.S. including INFLECTRA® (infliximab), Retacrit (epoetin zeta), and Nivestim (filgrastim); and a biosimilars pipeline consisting of 13 distinct biosimilar molecules in various stages of development. As part of its global biosimilars strategy, Pfizer supplies Celltrion's INFLECTRA® (infliximab-dyyb) in the U.S. and certain other markets across the globe.

About IXIFI™

IXIFI™ (infliximab-qbtx) is a chimeric human-murine mAb against tumor necrosis factor, approved as a biosimilar for all eligible indications of the reference product.(1) IXIFI has been approved in the U.S. for rheumatoid arthritis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.(1)

In February 2016, Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of 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.(4)

About Pfizer: Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

1. IXIFI (infliximab-qbtx) Prescribing Information. New York. NY: Pfizer Inc: 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdf. Accessed December 2017.
2. Pfizer. Pfizer Announces Positive Top-Line Results From Reflections B537-02 Study For PF-06438179 (Infliximab-Pfizer) A Potential Biosimilar To REMICADE® (Infliximab). September 2016. Available at: http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_reflections_b537_02_study_for_pf_06438179_infliximab_pfizer_a_potential_biosimilar_to_REMICADE_infliximab. Accessed December 2017.
3. Cohen SB, Alten R, Kameda H, Rehman MI, Schumacher K, Schmitt S, Hua SY, Sewell KL. A Randomized, Double-Blind Study Comparing PF-06438179/GP1111, a Potential Infliximab Biosimilar, and Infliximab, Both in Combination with MTX, As Treatment for Patients with Moderate to Severe Active RA Who Have Had an Inadequate Response to MTX Therapy [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). Available at: http://acrabstracts.org/abstract/a-randomized-double-blind-study-comparing-pf-06438179gp1111-a-potential-infliximab-biosimilar-and-infliximab-both-in-combination-with-mtx-as-treatment-for-patients-with-moderate-to-severe-active/. Accessed December 2017.
4. Novartis. Sandoz strengthens its biosimilars portfolio with acquisition of Pfizer's biosimilar infliximab in EEA. Available at: https://www.novartis.com/news/media-releases/sandoz-strengthens-its-biosimilars-portfolio-acquisition-pfizers-biosimilar. Accessed December 2017.

Most Popular Now

Pfizer's elranatamab granted FDA Breakthrough Ther…

Pfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administrati...

Salvat Laboratories announces submission of New Dr…

Salvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsi...

New insights on antibody responses to Omicron vari…

Knowing how well vaccination against one SARS-CoV-2 strain (with or without previous infection) counteracts infection with a different strain is a critical research quest...

The origin-of-life molecule, a key to cancer resea…

RNA, the molecule that gave rise to life, has been shown to be essential for repairing human genetic material and preventing mutations that might lead to developing cance...

Bayer with continued strong performance

The Bayer Group maintained its strong business performance across all three divisions in the third quarter. "Despite rising inflation and global supply chain problems, we...

Vividion Therapeutics names Jenna Goldberg as Chie…

Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision the...

Sugar molecules as a target in cancer therapy

Cancer cells use sugar molecules on their surface to disable attacks by the body's immune system. Researchers at the University of Basel now report on how this mechanism ...

COVID vaccination improves effectiveness of cancer…

Patients with nasopharyngeal cancer are often treated with drugs that activate their immune system against the tumor. Until now, it was feared that vaccination against Co...

Pfizer and BioNTech receive positive CHMP opinion …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron ...

Making melanoma immortal: Pitt scientists discover…

Scientists at the University of Pittsburgh School of Medicine have discovered the missing puzzle piece in the mystery of how melanoma tumors control their mortality. I...

Study reveals vaccine confidence declined consider…

A new study suggests that, despite the success of the COVID-19 vaccination campaigns, vaccine confidence has declined significantly since the start of the pandemic. Re...

New drug shows promise for fighting both COVID-19 …

While vaccination can provide life-saving protection against COVID-19, scientists are still searching for ways to treat severe infections, including in people who cannot ...