Sandoz commences mid-stage trial for Rituxan biosimilar
HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.
Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.
The company said it had developed a high-yield and large-scale production process for rituximab at its factory in Schaftenau, Austria.
“This key development milestone demonstrates that Sandoz, the pioneer in biosimilars, is on track to maintain its global leadership in the medium to long term,” Sandoz global head Jeff George said.
Indeed, while Sandoz has made biosimilars for the European market for years, alongside such companies as Teva Pharmaceutical Industries and Hospira, biosimilars largely have been limited to interferons and such drugs as Omnitrope (somatropin [rDNA origin]), a biosimilar of Pfizer’s growth disorder treatment, Genotropin. Biosimilar monoclonal antibodies are a much newer development, and analysts have said it could take years before they begin hitting the market in large numbers.
Mylan’s generic Precose gets green light from FDA
PITTSBURGH — The Food and Drug Administration has approved a generic diabetes drug made by Mylan, the drug maker said Tuesday.
Mylan announced the approval of acarbose tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a version of Bayer’s Precose, used with diet and exercise to improve glycemic control in adults with Type 2 diabetes.
The drug had sales of around $23 million during the 12-month period ended in September, according to IMS Health.
Pfizer’s Germano to speak at 2011 Armada Specialty Pharmacy Summit
FLORHAM PARK, N.J. — Pfizer president and general manager for specialty care and oncology, Geno Germano, will deliver the “State of the Pharma/Biotech Industry Address” at the 2011 Armada Specialty Pharmacy Summit, Armada Health Care said Tuesday.
The summit, which will take place in Las Vegas in May, is in its seventh year and is expected to bring 1,500 participants representing 400 specialty healthcare organizations, including specialty pharmacy providers, pharmaceutical and biotech companies, wholesale distributors and others.
Germano joined Pfizer when the company bought out Wyeth, where he was president of the U.S. and pharmaceutical business units. He previously served numerous other positions at Wyeth and also worked at Johnson & Johnson.
Earlier this month, Armada announced that former President George W. Bush would deliver the keynote speech at the summit.