Sandoz advances its biosimilars program with European Medicines Agency (EMA) acceptance of regulatory submission for biosimilar etanercept

  • Sandoz is seeking approval for all indications included in the reference product’s label which includes chronic inflammatory conditions like rheumatoid arthritis and psoriasis.
  • Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the biosimilar etanercept is highly similar to the reference product.
  • EMA acceptance follows recent FDA regulatory submission acceptance and is the third of ten regulatory filings planned over a three year period (2015-2017).

Holzkirchen, 8 December, …

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Phase III data shows Sandoz’ proposed biosimilar pegfilgrastim has similar safety and efficacy as the reference product

  • PROTECT 2 study compared safety and efficacy of the proposed biosimilar pegfilgrastim with the reference product for the prevention of neutropenia in patients with breast cancer.
  • The study met its primary endpoints demonstrating equivalence and non-inferiority to the reference product.
  • Data presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition.

Holzkirchen, 7 December 2015 – Sandoz, a Novartis company and global leader in biosimilars, today announced results from the PROTECT 2 study which compared the …

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