• 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, …