PHARMACY

Teva chief confident bill on follow-on biologics to appear in Congress

BY Alaric DeArment

NEW YORK The chief executive officer of Teva North America is confident that a bill to create a regulatory pathway for follow-on biologics will appear in Congress next year, according to published reports.

Bill Marth, chief executive of Teva Pharmaceutical Industries? North America division, told Reuters Tuesday that there was a “very good chance” that Congress would introduce a bill to allow follow-on biologics, also known as biosimilars, in 2009. 

Several large drug makers have already announced plans to create biosimilar divisions, including Merck & Co., Eli Lilly & Co. and AstraZeneca, which announced its own plan earlier this week.

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FDA approves Novadel’s Zolpimist for short-term insomnia treatment

BY Alaric DeArment

FLEMINGTON, N.J. The Food and Drug Administration has approved a drug by NovaDel Pharma for the short-term treatment of insomnia characterized by difficulties with sleep initiation, NovaDel announced Monday.

NovaDel said that Zolpimist (zolpidem tartrate) is its second product approved by the FDA that uses its proprietary NovaMist spray technology. The active ingredient in Zolpimist is the same as the one in Sanofi-Aventis’ Ambien.

“We believe that the FDA’s approval of Zolpimist provides patients with an important treatment option for insomnia, as Zolpimist provides rapid absorption from the oral mucosa,” NovaDel board chairman and interim CEO Steven Ratoff said.

Ambien had worldwide sales of $559.3 million for first six months of 2008, according to Sanofi-Aventis financial data.

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AstraZeneca considering entering biosimilars market

BY Alaric DeArment

LONDON AstraZeneca may soon start developing biosimilars, according to published reports.

David Brennan, the company’s CEO, told the Financial Times that depending on legislation being considered, the Anglo-Swedish drug maker might expand into creating follow-on versions of biologics that have lost patent protection.

Merck and Eli Lilly have also said they might develop biosimilars. Merck announced earlier this month that it would create a new biosimilars division, Merck BioVentures, to make follow-on and novel biologics using engineering technology from GlycoFi, a company it acquired in 2006. The Whitehouse Station, N.J.-based drug maker plans to launch its first biosimilar, the anemia drug MK-2578, in 2012 and have at least five biosimilar candidates at that time.

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