Biosimilars

Running from 11-14 November, the fifth annual Global Biosimilars Week awareness campaign has been launched by the IGBA, with the international off-patent association this year focusing on advancing access.

After a “solid start to the year”, Organon has delivered on analyst expectations with its third quarter results, despite ongoing questions surrounding future growth and market penetration of key compounds. Meanwhile, the firm’s filing for a biosimilar rival to Prolia/Xgeva has been accepted by the FDA.

Meitheal has announced a licensing agreement with parent company Hong Kong King-Friend to add another three biosimilars to its pipeline for the US market.

After under-delivering on already muted expectations, Biocon's optimistic future was overshadowed by pending FDA inspection outcomes on two of its facilities.

Biogen has struck another blow against European generic competitors to Tecfidera, after the European Patent Office upheld a dosage patent for the brand that runs until February 2028. Meanwhile, the firm reported flat biosimilars sales in the third quarter of 2024.

Alvotech and Advanz have celebrated a worldwide first with the European Medicines Agency’s acceptance of an application for their partnered golimumab biosimilar rival to Simponi.

Sandoz has raised its full-year guidance on the back of third-quarter results that saw the firm enjoy growth of more than a tenth, with biosimilars sales up by a whopping 37%.

Generics Bulletin reviews the latest regulatory developments across the world.

Respondents to the FDA’s questions over biosimilar development did not hold back. So, what is it: product-specific or product class-specific guidance? Or nothing?

In a citizen petition to the FDA, Alvotech has called on the US agency to refrain from approving as interchangeable certain Stelara biosimilars that use a different cell line to its own ustekinumab product – including the Pyzchiva version set to be brought to market by Samsung Bioepis and Sandoz.