Biosimilars Industry sentiments following Zarxios US approval Sandoz

Biosimilars Industry sentiments following Zarxio’s US approval Sandoz refrained from commenting on the price of Zarxio; however hinted it will be “competitively priced” Margaret A Hamburg, MD, FDA Commissioner 1: “Biosimilars will provide access to important therapies for patients who need them. Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards. ” Carol Lynch, Global Head of Biopharmaceuticals and Oncology Injectables, Sandoz 2: “Being the first, we also have the responsibility to ensure we’re educating our key stakeholder and customers so they understand why it is the data we have can be extrapolated. The product has been shown to be highly similar to the originator molecule. But I do think we’ll have some education to do. ” A Sandoz representative 3: “We're not commenting on price until the product launches, for competitive reasons. Sandoz is committed to bringing high-quality, competitively priced biosimilars to the U. S. market, including Zarxio. ” Amgen said in a statement that 4: “each manufacturer’s product will be distinct” and suggested it would keep promoting Neupogen. The company said it is has a “deep understanding of Neupogen based on extensive clinical experience in all five indications” and believes that it “continues to have an important role to play in helping patients. ” Gary Lyman, an oncologist at the Fred Hutchinson Cancer Research Center 4: “I don’t think it’s going to be an overnight sensation. I think oncologists are going to have to gain from experience that [biosimilars] are safe, they’re efficacious, and patient convenience and quality of life is maintained. ” 1 Sources: 1. FDA 2. i. Market Reports 3. Medpage Today 4. WSJ