New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse ...

Enzeevum, a biosimilar to Eylea, is approved in Canada for multiple retinal conditions, expanding treatment options for ophthalmologists. Biosimilars may offer cost-effective alternatives, potentially ...

Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

In the evolving biosimilar landscape, patent challenges remain a critical strategy to clear the path for market entry. Recent ...

As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...

The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process. The regulatory framework has been designed to reduce ...

The Delhi High Court in India has upheld the grant of a pharmaceutical patent to privately-held Swiss drugmaker Helsinn ...

India’s Zydus Lifesciences, an innovation-led life-sciences company with an international presence, has launched the world’s first biosimilar of nivolumab in India under the brand name Tishtha, ...

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

The FDA has approved Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Perjeta (pertuzumab). Poherdy, as approved, is indicated for use in adults with HER2-positive breast cancer, ...

The administration announced some proposals for the Food And Drug Administration. (Sarah Silbiger/Getty Images) The Trump administration is proposing changes to Food and Drug Administration guidelines ...