Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases

Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases

  • European Commission’s (EC) approval based on comprehensive data package confirming that Zessly® matches safety, efficacy and quality of reference medicine
  • Biosimilars such as Zessly enable earlier patient access to important medicines and positively impact healthcare systems
  • Zessly is the third EC approval for a Sandoz biosimilar in 12 months …
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Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases

Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases

  • European Commission’s (EC) approval based on comprehensive data package confirming that Zessly® matches safety, efficacy and quality of reference medicine
  • Biosimilars such as Zessly enable earlier patient access to important medicines and positively impact healthcare systems
  • Zessly is the third EC approval for a Sandoz biosimilar in 12 months …
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Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab

Holzkirchen, May 2, 2018 — Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab.

Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.

There is a …

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Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab

Holzkirchen, May 2, 2018 — Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab.

Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.

There is a …

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