Europe

2025 is likely to be a game-changing year for the pharmaceutical industry. Generics Bulletin sat down with Medicines for Europe’s Adrian van den Hoven and Beata Stepniewska to discuss the opportunities of the Critical Medicines Act and EU pharmaceutical legislation revision.

Although it was no walk in the park, Europe’s leading life sciences VC firm has amassed a huge pot of cash for biotechs and will use its AI capabilities to find up to 60 start-ups to support.

A new methodology for measuring pharmaceutical company carbon footprints could lead to a single standard for producing these calculations that is applicable to all medicines sold in France, said the industry association, Leem. However, it warned that there remains uncertainty about how the methodology will work in practice.

Fresenius has become the latest firm to launch a Stelara biosimilar in both the US and Europe, bringing partner Formycon’s Otulfi version to market. But with heavy discounting already seen in the US and multiple competitors already established in the EU, will the firm be able to stand out from the crowd?

Reporting year-end financials, the Fresenius group spoke at length about its ambition for Fresenius Kabi to reach the billion euro milestone in annual revenues for its prospering Biopharma unit in the coming years, as management also addressed queries about the dynamic pricing environment ahead of the firm’s imminent launch of a biosimilar to Stelara in the US.

Assimilated EU medtech law used in Great Britain will not be sunsetted on 26 May 2025, as originally provided for. That was the first decision published by the MHRA in the wake of its recent consultation on shaping the regulatory system.

Generics Bulletin reviews the latest regulatory developments across the world.

The Polish player has won two grants sourced from the government’s National Recovery and Resilience Plan, which has given out $28.1m in funding in the latest round.

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.

Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.