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Teva launches generic version of Prevpac Kit

BY Alaric DeArment

NORTH WALES, Pa. — Teva Pharmaceutical Industries has introduced a generic version of an antibiotic drug kit, the company said.

Teva, through U.S. subsidiary Teva Pharmaceuticals, announced the introduction of 30-mg lansoprazole delayed-release capsules, 500-mg amoxicillin capsules and 500-mg clarithromycin tablets. The treatment is packaged in 14 cards with eight pills, designed for 14 days of treatment.

The treatment is a generic version of Takeda’s Prevpac Kit.

 

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Kardashian Beauty to expand into South Africa

BY Antoinette Alexander

SANTA MONICA, Calif. — Boldface Group, a Santa Monica, Calif.-based celebrity beauty licensing company, has announced that it is expanding international distribution and will launch Kardashian Beauty into South Africa.

The company’s South African distributor Azulade Marketing will launch Kardashian Beauty into Stuttafords Stores beginning Nov. 15, 2013.

Stuttafords is a boutique-like multi category retailer that sells international beauty brands, such as Dior, Estée Lauder, Cartier, Bulgari, Dolce & Gabbana, Clinique and others.

Azulade Marketing projects that after the initial limited launch in Stuttafords’ 15 stores, Kardashian Beauty will expand its distribution throughout the country in 2014 to up to 700 additional retail venues with the future distribution it has underway.
 

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Hospira wins approval for Europe’s first biosimilar monoclonal antibody

BY Alaric DeArment

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.

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