Hospira wins approval for Europe’s first biosimilar monoclonal antibody
LEAMINGTON SPA, United Kingdom — European regulators have approved the European Union’s first biosimilar monoclonal antibody. The new product, made by U.S.-based Hospira, comes seven years after the approval of Europe’s first biosimilar.
Hospira announced Tuesday the European Medicines Agency’s approval of Inflectra (infliximab) for the treatment of autoimmune disorders like rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.
The product is a biosimilar version of Merck’s and Johnson & Johnson’s Remicade, which had sales in Europe of $2 billion last year, according to Merck. Merck and J&J agreed to split sales of the drug in 2011 as part of a settlement in a lawsuit. According to a study published last year in the Generics and Biosimilars Initiative Journal, the introduction of biosimilar monoclonal antibodies in Europe is expected to deliver savings of more than $27 billion by 2020, particularly in France, Germany and the United Kingdom.
"The rigorous scientific review and approval process by the EMA and [European Commission] confirms that Inflectra has demonstrated similar quality, efficacy and safety to Remicade," Hospira corporate VP and chief medical officer Stan Bukofzer said. "For more than a decade, biologic medicines have been pivotal in treating a range of inflammatory conditions, so the granting of marketing authorization in Europe is a major milestone for Inflectra and for the future of biologic therapy."
The growth disorder treatment Omnitrope (somatropin [rDNA origin]), made by Novartis generics division Sandoz, was the first biosimilar to win approval in Europe, in 2006. The drug, which is a version of Pfizer’s Genotropin, was also approved by the U.S. Food and Drug Administration the same year as a special consideration. However, it was only with the approval of amendments to the Patient Protection and Affordable Care Act in 2010 that the United States got its own abbreviated approval pathway for biosimilars, and the FDA is still working on regulations.
Dr. Fresh participates in 10th annual Halloween Candy Buyback program
BUENA PARK, Calif. — Just a few pieces of Halloween candy can go a long way toward satisfying kids’ cravings for sweet treats, but large quantities lead to tooth decay. That’s why dentists are teaming up to host this year’s Halloween Candy Buyback program.
Participating dentists are asking children to drop in the day after Halloween to donate their candy for a great cause. In exchange, children can receive prizes like Dr. Fresh’s classic FireFly toothbrush with suction cup, featuring a light-up timer that promotes thorough brushing and good oral care habits.
Through the program, which marks its 10th anniversary in 2013, children bring unopened candy to local dental offices, and it is then sent through Operation Gratitude as part of holiday care packages to troops serving overseas. It’s a win-win situation that rewards children with better oral hygiene and lets them show appreciation to America’s service men and women.
“Participating dentists are doing their part to encourage kids to enjoy all the fun of trick-or-treating, without overindulging in cavity-causing sweets,” stated Chris Kammer, the Wisconsin dentist who founded the Halloween Candy Buyback Program. “Kids love the colorful, glowing FireFly toothbrushes they get in return for the candy they donate, and they are thrilled to help send a little piece of home to our soldiers far away.”
Dentists who wish to participate in the Halloween Candy Buyback program will be able to purchase classic FireFly toothbrushes with suction cup holders for 85 cents each, versus the regular price of $1.25. The toothbrushes come in red, green, pink, yellow and blue, and can be purchased at the special price through Nov. 15 2013 at DrFreshDental.com
Jif whips up new peanut butter spreads
ORRVILLE, Ohio — Jif Peanut Butter announced on Tuesday a new whipped flavor innovation to add to its line of peanut butter products.
Jif Whips Peanut Butter Spread is a new smooth, fluffy spread that is whipped. It’s a more ideal choice for dipping snacks and still provides as much versatility in snacking and spreading peanut butter on consumer favorites, like bagels or fruits, the company stated.
Jif Whips is available in two on-going varieties: whipped peanut butter and whipped peanut butter and chocolate. In addition, Jif Whips is rolling out a seasonal whipped peanut butter and chocolate mint variety for a limited time.
Jif Whips Whipped Peanut Butter has a suggested retail price of $3.49 for a 15-oz. wide-mouth tub. Whipped Peanut Butter and Chocolate comes in a slightly larger 15.9-oz. tub with a SRP of $3.89. The seasonal Whipped Peanut Butter and Chocolate Mint is available in a 15.9-oz. tub with a SRP of $2.99.
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