Sandoz Receives FDA Approval for Enzeevu (aflibercept-abzv), Further Strengthening Biosimilars’ Position in the US Page 1

Ad hoc announcement pursuant to Art. 53 SIX Swiss Exchange Listing Rules

• Enzeevu (aflibercept-abzv) approved for the treatment of neovascular age-related macular degeneration
• Enhances the leading U.S. ophthalmology portfolio and increases patient access
• This is expected to be a major growth driver for biosimilars in the US

Basel, August 12, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generics and biosimilars, today announced that the U.S. Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. Enzeevu is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD).(1) In addition, the FDA has provisionally determined that Enzeevu would be interchangeable with the reference medicine, as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.

Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said: “nAMD, or wet AMD, remains a leading cause of vision loss in patients over 50 years of age in North America. This condition affects millions of people and leads to significant challenges in their daily lives due to the progressive loss of central vision. The U.S. approval of Enzeevu is an important milestone in Sandoz’s efforts to significantly improve the lives of patients affected by this incurable disease.”

Enzeevu is a key biosimilar value driver for the company and this approval is an important step in advancing Sandoz’s growth strategy by further expanding its leading U.S. ophthalmology portfolio. The timing of the launch will depend on several factors, including the progress and outcome of any pending or potential future related litigation or possible settlements.

nAMD, also called wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision loss in patients over 50 years of age in North America.(2)

Jeff Todd, JD, President and CEO of Prevent Blindness, said, “As vision fades, so can a person’s connection to the world. We welcome all treatment options that help preserve vision and meet the unique needs of the individual, so people with wet AMD can potentially remain independent longer. Currently, there is no cure for this disease and long-term treatment can be costly. More FDA-approved options, including biosimilars, can help make healthcare more personalized and affordable.”

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