Carl Byrnes

Ashwani Verma

Balaji Prasad

Christopher Uhde

Di Zhao

Niall Alexander

Vineet Agra

- **Alvotech** announced on **October 6, 2025**, that the **European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for AVT23**, a proposed biosimilar to Xolair® (omalizumab).  **[1898416_0001171843-25-006280_f6k_100625.htm:0]** **[1898416_0001171843-25-006280_exh_991.htm:0]** 
- **Advanz Pharma Holdco Limited** has licensed commercialization rights for AVT23 in the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand.  **[1898416_0001171843-25-006280_f6k_100625.htm:0]** **[1898416_0001171843-25-006280_exh_991.htm:0]** 
- This EMA acceptance follows the **UK Medicines and Healthcare Products Regulatory Agency (MHRA)'s acceptance of an MAA for AVT23 earlier this year**.  **[1898416_0001171843-25-006280_exh_991.htm:0]**

Alvotech: European Medicines Agency Accepts Marketing Application for Biosimilar AVT23

- Alvotech's commercialization partner in Japan, Fuji Pharma Co., Ltd., received marketing authorization for **three new biosimilars**: AVT03 (referencing Xgeva/Ranmark), AVT05 (referencing Simponi), and AVT06 (referencing Eylea).  **[1898416_0001171843-25-006012_f6k_092225.htm:0]** **[1898416_0001171843-25-006012_exh_991.htm:0]** 
- **AVT05** is the **first golimumab biosimilar** to be approved for sale in major markets globally.  **[1898416_0001171843-25-006012_exh_991.htm:0]** 
- These approvals, announced on **September 19, 2025**, expand Alvotech's presence in Japan, following the successful launch of a Stelara biosimilar in **May 2024** with Fuji Pharma.  **[1898416_0001171843-25-006012_f6k_092225.htm:0]** **[1898416_0001171843-25-006012_exh_991.htm:0]**

Alvotech (ALVO)