AstraZeneca considering entering biosimilars market
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.
AstraZeneca seeks approval for use of Nexium in infants
NEW YORK AstraZeneca has submitted a supplemental application to the Food and Drug Administration for the use of the drug Nexium as a short-term treatment of gastroesophageal reflux disease in infants.
GERD, which is closely related to acid-reflux disease, affects about 7 million children in the United States.
The FDA has already approved Nexium (esomeprazole magnesium) for use in children between 1 and 17 years of age, though AstraZeneca hopes to have it approved in infants less than a year old.
Amgen applies for FDA approval of denosumab osteoporosis, cancer treatment
THOUSAND OAKS, Calif. Amgen has submitted an approval application to the Food and Drug Administration for denosumab, a treatment for women with postmenopausal osteoporosis and patients undergoing hormone ablation for prostate and breast cancer, the biotech company announced Friday.
The approval application contains data from six phase 3 trials involving more than 11,000 patients, the company said. Amgen also plans to submit applications in Canada, Australia, the European Union and Switzerland.
“Today’s submission marks a significant step toward realizing our goal of making this important therapeutic available to patients at risk for fractures, for whom there is a significant need for new therapies,” Amgen EVP for research and development Roger Perlmutter said.