Biosimilars

The IGBA has introduced its first global intellectual property and competition report, addressing the urgent need to reform current regulations. But, in a bid to increase access to medicines across the world, did it stop short at just IP and patents?

US President Trump’s threat of a “25% or higher” import tariff on pharmaceuticals sends ripples through an already uncertain environment. With about half of generics sourced from India, captains of industry read between the lines

In its latest draft standard contract for 2025/26, the National Health Service in England has proposed enhanced prescribing requirements “in recognition of the increasing importance of biosimilars in the provision of biological medicines.”

Generics Bulletin reviews the latest regulatory developments across the world.

Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.

While quarterly revenues show ups and downs in each region, Lupin is set on continued growth, with a touch of complexity and innovation – including shifting its thinking on the attractiveness of biosimilars.

Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

In its latest draft standard contract for 2025/26, the National Health Service in England has proposed enhanced prescribing requirements “in recognition of the increasing importance of biosimilars in the provision of biological medicines.”

Samsung Bioepis is only the second firm to receive a US FDA endorsement for its denosumab biosimilars, with the nod coming at the same time as formal European Commission approval. But plenty more firms are waiting in line with their own rivals to Prolia and Xgeva.