• Net sales grew 5% (cc[1], +7% USD) mainly driven by:
  • Cosentyx grew to USD 701 million, (+40% cc) with strong growth in all indications in the US and EU
  • Entresto sales more than doubled to USD 239 million, (+113% cc) driven by continued uptake worldwide
  • Oncology grew 10% (cc) driven by continued growth from Promacta/Revolade, Tafinlar + Mekinist and Jakavi, uptake of Kisqali and Kymriah and contribution from the AAA acquisition
• Core[ …

• Zessly^® (infliximab) matched the reference medicine in terms of safety and efficacy at 54 weeks, even in patients who switched from the reference medicine to Zessly[1]
• Switching from the reference medicine to Erelzi^® (etanercept) did not impact efficacy and safety in patients with moderate to severe rheumatoid arthritis at 48 weeks[2]
• Nearly 320 million people in Europe are expected to have limited access to disease-modifying anti-rheumatic medicines, underscoring the value of Zessly and Erelzi[3 …

• Sandoz is seeking approval of proposed biosimilar adalimumab for use in all reference medicine indications including those in rheumatology, gastroenterology and dermatology
• Positive CHMP opinion based on comprehensive analytical, preclinical and clinical data package that shows proposed biosimilar adalimumab matches reference medicine
• This recommendation marks the fourth positive CHMP opinion for a Sandoz biosimilar within 18 months

Holzkirchen, June 1, 2018 – Sandoz, a Novartis division and the global leader in biosimilars, …

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 …

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 …