NEW YORK, NY, USA I April 5, 2016 I The United States (U.S.) Food and Drug Administration (FDA) today approved Celltrion’s INFLECTRA™ (biosimilar infliximab) across all eligible indications of the reference product, Remicade® (infliximab).1 INFLECTRA is now the first and only biosimilar monoclonal antibody (mAb) therapy, and only the second biosimilar, to be approved in the U.S.
Hospira, now a Pfizer company, entered into an agreement with Celltrion Inc. and Celltrion Healthcare, Co., Ltd. in 2009 for several potential biosimilar products, including INFLECTRA. Pfizer holds exclusive commercialization rights to INFLECTRA in the U.S. and certain other jurisdictions.
“The introduction of high-quality, effective biosimilars provides an opportunity to expand access to important medicines,” said Salomon Azoulay, MD, senior vice president and chief medical officer, Pfizer Global Established Pharma Business. “As a leading global biologics company with several biosimilar products in our pipeline, we appreciate the significance of this milestone in developing a pathway for biosimilars to come to market in the U.S., and in helping advance their adoption in the healthcare system.”
INFLECTRA is a treatment indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease.
The FDA approval was based on the comprehensive data package submitted by Celltrion demonstrating a high degree of similarity between INFLECTRA and the U.S. reference product, Remicade. The FDA’s decision follows the February 9, 2016 FDA Arthritis Advisory Committee’s recommendation to approve proposed biosimilar infliximab across all eligible indications, by a vote of 21-3.
“Our experience in other markets across the globe demonstrates that biosimilars can be a welcome option for patients, physicians and others,” said Jenny Alltoft, head of global biosimilars, Pfizer Inc. “Pfizer is proud to play a leading role in preparing the U.S. market for biosimilars. We are committed to bringing these important medicines to patients in the U.S. as quickly as possible. While launch timing for INFLECTRA will ultimately depend on a number of factors such as marketplace dynamics and intellectual property considerations, we are continuing with the preparation of our launch plans for 2016.”
Pfizer Inc.: 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 healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer healthcare 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, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
SOURCE: Pfizer
Post Views: 123
NEW YORK, NY, USA I April 5, 2016 I The United States (U.S.) Food and Drug Administration (FDA) today approved Celltrion’s INFLECTRA™ (biosimilar infliximab) across all eligible indications of the reference product, Remicade® (infliximab).1 INFLECTRA is now the first and only biosimilar monoclonal antibody (mAb) therapy, and only the second biosimilar, to be approved in the U.S.
Hospira, now a Pfizer company, entered into an agreement with Celltrion Inc. and Celltrion Healthcare, Co., Ltd. in 2009 for several potential biosimilar products, including INFLECTRA. Pfizer holds exclusive commercialization rights to INFLECTRA in the U.S. and certain other jurisdictions.
“The introduction of high-quality, effective biosimilars provides an opportunity to expand access to important medicines,” said Salomon Azoulay, MD, senior vice president and chief medical officer, Pfizer Global Established Pharma Business. “As a leading global biologics company with several biosimilar products in our pipeline, we appreciate the significance of this milestone in developing a pathway for biosimilars to come to market in the U.S., and in helping advance their adoption in the healthcare system.”
INFLECTRA is a treatment indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease.
The FDA approval was based on the comprehensive data package submitted by Celltrion demonstrating a high degree of similarity between INFLECTRA and the U.S. reference product, Remicade. The FDA’s decision follows the February 9, 2016 FDA Arthritis Advisory Committee’s recommendation to approve proposed biosimilar infliximab across all eligible indications, by a vote of 21-3.
“Our experience in other markets across the globe demonstrates that biosimilars can be a welcome option for patients, physicians and others,” said Jenny Alltoft, head of global biosimilars, Pfizer Inc. “Pfizer is proud to play a leading role in preparing the U.S. market for biosimilars. We are committed to bringing these important medicines to patients in the U.S. as quickly as possible. While launch timing for INFLECTRA will ultimately depend on a number of factors such as marketplace dynamics and intellectual property considerations, we are continuing with the preparation of our launch plans for 2016.”
Pfizer Inc.: 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 healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer healthcare 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, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
SOURCE: Pfizer
Post Views: 123
