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Pfizer introduces first and only biosimilar monoclonal antibody therapy

BY Michael Johnsen
NEW YORK – The United States Food and Drug Administration on Tuesday approved Celltrion’s Inflectra (biosimilar infliximab) across all eligible indications of the reference product, Remicade (infliximab). Inflectra is now the first and only biosimilar monoclonal antibody (mAb) therapy, and only the second biosimilar, to be approved in the U.S.
 
“The introduction of high-quality, effective biosimilars provides an opportunity to expand access to important medicines,” stated Salomon Azoulay, SVP 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.”
 
Hospira, now a Pfizer company, entered into an agreement with Celltrion and Celltrion Healthcare in 2009 for several potential biosimilar products, including Inflectra. Pfizer holds exclusive commercialization rights to Inflectra in the U.S. and certain other jurisdictions.
 
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 Feb. 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,” noted Jenny Alltoft, head of global biosimilars, Pfizer. “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.”
 
 
 
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Beauty, seasonal merchandise drive March sales at Fred’s

BY Gina Acosta

MEMPHIS, Tenn. — Fred’s says beauty, personal care and Easter merchandise drove traffic in March, as the company reported an 11% increase in net sales to $214.4 million.

Fred's same store sales for the month rose 1.8% versus an increase of 1.9% for the year-earlier period. Fred's total sales for the first two months of fiscal 2016 increased 11% to $385.8 million compared with $346.8 million for the same period last year. On a comparable store basis, year-to-date sales increased 1.3% versus an increase of 0.9% for the year-earlier period.

"We are pleased to report that total March sales increased at the high end of our guidance, while comparable stores sales came in near the midrange," said Jerry A. Shore, CEO. "Much of the total increase can be attributed to the April 2015 acquisition of EntrustRx specialty pharmacy. Next month, we begin cycling the acquisition and in May, total sales comparisons will be normalized. Our traffic-driving initiatives for the pharmacy department continue to take hold, and for the second consecutive month, comparable scripts and sales were positive."

Fred's, Inc. and subsidiaries operate 660 discount general merchandise stores and three specialty pharmacy-only locations in 15 states in the southeastern United States. 

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Ahold USA taps Canadian retailer to lead U.S. merchandising

BY Michael Johnsen
CARLISLE, Pa. – Ahold USA on Tuesday announced that Andrew Iacobucci has been appointed to EVP merchandising effective April 11. 
 
“We are delighted that Andrew is joining our team, and he brings outstanding merchandising experience to help us on our journey from good to great,” stated James McCann, COO, Ahold USA.
 
In this role, Iacobucci will focus on leading a merchandising team that supports Ahold USA and its four retail divisions, Stop & Shop New England, Stop & Shop New York Metro, Giant Landover and Giant Carlisle.
 
Iacobucci brings an extensive background in the supermarket industry to his new role with Ahold USA, including a mix of merchandising, P&L ownership and retail strategy experience. In the last ten years, he has held several leadership positions at Loblaw Companies Limited, the largest food retailer in Canada. Most recently, Iacobucci was president of the Discount Division, a $17 billion business.
 
Before that, he held senior leadership roles in Loblaw’s Grocery Discount Division, Drugstore Business Unit, Central Store Operations team, Superstores team and Corporate Development function. Prior to his time at Loblaw, Iacobucci spent several years at Monitor Group, a global strategy consulting firm where he focused on U.S. retail.
 
With a bachelor’s degree in economics from Queens University in Ontario and a law degree from the University of Toronto, Iacobucci is relocating to the United States from Canada.
 
 
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