PHARMACY

Sandoz Canada GM to lead new CGPA Biosimilars Board

BY Michael Johnsen

TORONTO – The Canadian Generic Pharmaceutical Association announced Tuesday the establishment of a new CGPA Biosimilars Board and the election of Michel Robidoux, president and general manager of Sandoz Canada, as its inaugural chair.
 
"The establishment of the new CGPA Biosimilars Board signifies the focus our industry is placing on ensuring that Canada is a viable market for the production and sale of biosimilar treatments," said Robidoux. "The establishment of clear rules for the approval and reimbursement of cost-saving biosimilar products in Canada is essential for the ongoing sustainability of both public and employer-sponsored drug plans, and to ensure that more Canadians can gain access to the treatments they need."
 
"We have an important role to play in educating patients, prescribers and drug plan sponsors on biosimilar products," Robidoux added. "As the worldwide biosimilars market continues to rapidly evolve with more products becoming available, we will bring that international experience to Canada."
 
Robidoux was appointed president and general manager for Sandoz Canada in 2010 and has more than 25 years of experience in the pharmaceutical, generic, consumer and medical device industry. He originally joined Sandoz Canada as VP sales in 2008. Before joining Sandoz, Robidoux was VP at Roche for various business units within the company such as Diabetes Care, Professional Diagnostics, Molecular Diagnostics and also Applied Science. Prior to Roche, he worked at Bayer for seven years in sales and marketing.
 
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FDA files sDNA for Pradaxa

BY Ryan Chavis

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals on Monday announced that the Food and Drug Administration has filed a supplemental new drug application for Pradaxa (dabigatran etexilate mesylate) to prevent deep venous thrombosis and pulmonary embolism in patients who have had hip replacement surgery. If the sNDA is granted approval, this will mark the fourth indication for the drug.
 
According to the company, almost 300,000 hip-replacement surgeries are performed each year in the United States, without preventative treatment, incidences of DVT range from 40% to 60%. Fatal PE occurs in one-of-500 patients, the company said. 
 
“Total hip replacement is a common procedure, and preventive anticoagulant treatment is recommended because of the potential for DVT and PE, which can be life-threatening for some patients,” said Sabine Luik, MD, SVP, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals. “The acceptance of this sNDA is another step toward expanding the therapeutic uses for Pradaxa to improve patient outcomes in this population.”
 
Pradaxa first received FDA approval in 2010 and was approved for two additional indications — including the treatment of DVT and PE — in 2014. 
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Mylan launches generic Generess Fe

BY Ryan Chavis

POTTERS BAR, ENGLAND and PITTSBURGH — Mylan on Tuesday announced the launch of norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable), the generic version of Generess Fe tablets from Warner Chilcott. 
 
The drug is indicated to prevent pregnancy in women who decide to use oral contraceptives. The immediate shipment of the tablets marks the company’s ninth oral contraceptive product launch in the United States, according to Mylan. 
 
Norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable) had sales of $114.7 million for the 12 months ending Dec 31, according to data from IMS Health. 
 
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