Why is this significant?

Biosimilars production was negatively impacted by COVID-19 and the US is behind the EU in biosimilar approvals (40 vs. 74 in the EU)[1]. In 2022 the US approved 47% of the biosimilar applications received, the highest to date. Biosimilars can significantly reduce drug costs and expand access to expensive biologics-based therapies.

Why Could this Impact Care?

Biosimilars and their expedited approval process established to provide more treatment options, increase patient access, and potentially reduce the cost of therapies through competition.

1. Alymsys injection approved for multiple cancer indications (reference Avastin).

2. Cimerli injection approved to treat wet age-related macular degeneration, macular edema, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization (reference Lucentis). First interchangeable for ranibizumab.

3. Fylnetra injection approved to decrease the incidence of infection in patients with nonmyeloid malignancies receiving anti-cancer drugs (reference Neulasta).

4. Idacio injection approved to treat inflammatory conditions (reference Humira).

5. Releuko injection approved to treat and prevent the chemotherapy complication febrile neutropenia (reference Neupogen).

6. Stimufend injection approved to decrease the incidence of infection in patients with non-myeloid malignancies receiving anti-cancer drugs (reference Neulasta).

7. Vegzelma injection approved for multiple cancer indications (reference Avastin).