Generics

FDA approves Celltrion's Actemra biosimilar
Avtozma is indicated for the treatment of rheumatoid arthritis, giant cell arteritis and other ailments.
Breckenridge obtains FDA OK for generic Afinitor Disperz
Everolimus TFOS is a kinase inhibitor indicated in adult and pediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected.

Camber launches sirolimus oral solution

Sirolimus oral solution is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in certain patients.
Lupin receives FDA nod for generic Atrovent

Ipratropium bromide nasal solution 0.06% is indicated for symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children aged five years and older.
AAM: Redesigned Medicare drug program still allows PBMs to deny patients access to lower-cost generics, biosimilars

AAM submitted comments to CMS, highlighting the extent and ways in which Part D sponsors and their PBMs engage in practices that favor, intentionally or unintentionally, more expensive reference drugs and biological products over generics.
FDA accepts Alvotech, Teva's BLAs for Simponi biosimilars

Simponi and Simponi Aria (golimumab) are prescribed to treat a variety of inflammatory conditions.
FDA gives Lupin OK for new generic, tentative nod for generic Triumeq

The FDA has given Lupin approval for generic Entresto, and tentative approval for generic Triumeq.
Organizations react to administration's new tariffs

Several organizations, including the National Retail Federation, are weighing in on the impact of the new tariffs on China and Canada.
FDA gives Amneal permission for 2 new generics, tentative OK for generic Xifaxan

The approvals provide therapies for dementia, oncology and gastrointestinal disease.
Glenmark launches generic vitamin K1 injectable emulsion

Vitamin K1 injectable emulsion had a market value of approximately $19.7 million, for the 12 months ending November 2024, per IQVIA.

FDA approves Celltrion's Actemra biosimilar

Breckenridge obtains FDA OK for generic Afinitor Disperz

Camber launches sirolimus oral solution

Lupin receives FDA nod for generic Atrovent

AAM: Redesigned Medicare drug program still allows PBMs to deny patients access to lower-cost generics, biosimilars

FDA accepts Alvotech, Teva's BLAs for Simponi biosimilars

FDA gives Lupin OK for new generic, tentative nod for generic Triumeq

Organizations react to administration's new tariffs

FDA gives Amneal permission for 2 new generics, tentative OK for generic Xifaxan

Glenmark launches generic vitamin K1 injectable emulsion