The FDA plans to eliminate comparative clinical study requirements that currently add $24 million and up to eight years to ...

Amneal Pharmaceuticals and mAbxience received Food and Drug Administration approval for two biosimilars. The companies said Monday that the FDA greenlit Biologics Licensing Applications for Boncresa, ...

Mark Cuban Cost Plus Drug Co. has added Vegzelma, a biosimilar indicated for six cancer types, to its marketplace for hospitals and other healthcare providers. The company plans to expand its ...

The proposed aflibercept biosimilar is intended to treat ophthalmic disorders. This FDA submission follows the licensing agreement under which Fresenius Kabi will exclusively commercialize the ...

Fact: branded biologic drugs are consistently among the most expensive in our healthcare system. 1 Compounding this, chronic conditions – often treated with biologics – are becoming increasingly ...

A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...

Every day, I think about the patients waiting for medicines that could change, or even save, their lives. For them, access is not a statistic. It is hope, health, and a chance for a better future.

The Development: The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of ...

The biosimilar Hyrimoz showed similar flare rates to Humira, but 25% of patients experienced adverse events, mainly injection site reactions. Injection pain, linked to Hyrimoz's citrate content and ...

(RTTNews) - Fresenius (FRE.DE) announced the launch of its denosumab biosimilars, Conexxence and Bomyntra, in Europe. The biosimilars received approval from the European Commission in July 2025 for ...

Armlupeg, a biosimilar to Neulasta, is approved for reducing febrile neutropenia in non-myeloid malignancy patients undergoing myelosuppressive chemotherapy. Lupin's FDA-approved facility in India ...

Data demonstrate a high degree of similarity between Armlupeg and the reference product. The Food and Drug Administration (FDA) has approved Armlupeg ™ (pegfilgrastim-unne), a biosimilar to Neulasta ® ...