Hospira and STADA's Biosimilar Epoetin Retacrit Receives Positive Opinion Recommending EU Approval
Hospira (Lake Forest, IL) has received a "positive opinion" recommending European Union (EU) approval for its biosimilar Retacrit (epoetin zeta), a treatment for anemia associated with chronic renal failure and chemotherapy-induced anemia.
Hospira (Lake Forest, IL) has received a "positive opinion" recommending European Union (EU) approval for its biosimilar Retacrit (epoetin zeta), a treatment for anemia associated with chronic renal failure and chemotherapy-induced anemia. Retacrit is a similar biologic, often referred to as a biosimilar or a biogeneric, to epoetin alfa.
The Committee for Medicinal Products for Human Use (CHMP) issued the positive opinion, and the European Commission, which approves pharmaceuticals for use in Europe, usually follows CHMP recommendations. Hospira expects EU approval for Retacrit in late 2007. The company plans to launch the product, Hospira's first marketed similar biologic, in various EU countries beginning in early 2008.
In late 2006, Hospira, STADA Arzneimittel AG (Bad Vilbel, Germany), and BIOCEUTICALS Arzneimittel AG (Bad Vilbel, Germany) announced development, manufacturing, and distribution agreements for epoetin zeta. Under these agreements, Hospira obtained exclusive distribution rights for the product in countries including the US and much of Europe, with the exception of Germany, where Hospira and STADA will both market the product. The epoetin zeta project is being pursued through BIOCEUTICALS, a company spun out of STADA. STADA controlled the development process and conducted the approval process on behalf of BIOCEUTICALS and Hospira. Hospira has significantly invested in expanding to develop, manufacture, and market similar biologics.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
