The Novartis Group of companies, recently provided comments on the U.S. Food and Drug Administration (FDA) Proposed Rule entitled “Designation of Official Names and Proper Names for Certain Biological Products”.

As the first company to market a biosimilar in the US, Sandoz, a Novartis company, shares the FDA’s commitment to patient safety and to ensuring accurate perceptions of the safety and effectiveness of biological products.

Sandoz believes biosimilars and interchangeable biologics should share the same non-proprietary name as their respective reference products and that …

  • Sandoz demonstrates commitment to oncology by seeking approval for its proposed biosimilar pegfilgrastim.
  • Sandoz believes that the totality of evidence in its submission, including three pivotal clinical studies, will demonstrate that the proposed biosimilar is highly similar to the reference product.
  • Proposed biosimilar pegfilgrastim filing is the second of ten regulatory filings planned over the next three years.

Holzkirchen, November 18, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US …

Generic medicines saved the US healthcare system a record USD 254 billion in 2014, according to a new report compiled by the IMS Institute for Healthcare Informatics on behalf of the US Generic Pharmaceutical Association (GPhA).

Chip Davis, President and CEO of the GPhA, said: “The facts are irrefutable, generic drugs drive enormous health care savings.

“This new report reinforces that generic drugs are a critical part of any solution to rising costs for patients, payors and the entire healthcare system. Safe, effective and more affordable generic medicines mean increased …