Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim

  • Sandoz’ late-stage biosimilar pipeline gains momentum with sustained investment – five of 10 planned regulatory filings achieved

  • Sandoz believes that the totality of evidence in its submission, including three pivotal clinical studies, demonstrates that the proposed biosimilar is highly similar to the reference product.

  • Sandoz is the European market leader in both the daily G-CSF class and for biosimilar filgrastim.

Holzkirchen, 11 February, 2016 – Sandoz, a Novartis company and the global leader in biosimilars, …

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Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim

  • Sandoz’ late-stage biosimilar pipeline gains momentum with sustained investment – five of 10 planned regulatory filings achieved

  • Sandoz believes that the totality of evidence in its submission, including three pivotal clinical studies, demonstrates that the proposed biosimilar is highly similar to the reference product.

  • Sandoz is the European market leader in both the daily G-CSF class and for biosimilar filgrastim.

Holzkirchen, 11 February, 2016 – Sandoz, a Novartis company and the global leader in biosimilars, …

/by