Supply Chain

The European Commission's 100-day countdown to deliver a Critical Medicines Act, aimed at improving the EU's resilience to supply chain disruptions and price volatility, began last December. Meanwhile, negotiations over the proposed package that will reform the over 20-year-old EU pharmaceutical legislation are now in the hands of the Council of the EU. The Pink Sheet examines what to expect for these key pieces of legislation this year.

Drug companies are being invited to participate in a new pilot project that the five Nordic countries will run to see if they can improve the availability of certain critical products that are used in hospitals.

The BGMA has lauded as “comprehensive and welcome” a report published by the Royal Pharmaceutical Society on UK shortages, just weeks after the BGMA put forward its own supply-chain policy proposals.

The Therapeutic Goods Administration says it wants to balance regulatory burden on sponsors with the need to improve its monitoring of medicine shortages.

Tariffs are expected again under a second Trump Administration and the future of the Americas Partnership for Economic Prosperity is uncertain, says the Personal Care Products Council, which will continue to push for regulatory alignment and lower trade barriers.

Coherus BioSciences will have to weather the storm of supply interruptions for its sole biosimilar product, Udenyca, in the final quarter of 2024.

In the first earnings call since Amgen confirmed launch of the first US biosimilar to Regeneron’s near $6bn Eylea brand, the originator spoke of its confidence in defending its brand, while also touching on how supply issues for repackaged Avastin had impacted its operations.

All eyes are on Eylea, after Amgen said last week that it would launch the first US biosimilar in the face of ongoing litigation. The California-based player has spoken of its prospects in the wet-AMD space, including a desire to chart its own path amid supply shortages for Avastin.

With a looming deadline of 1 January 2025 for firms supplying Northern Ireland to comply with the Windsor Framework, UK generics and biosimilars association the BGMA has warned of potential supply interruptions due to requirements that include a “UK only” label for all packs as well as UK-based batch testing for biologicals.

The 2025 social security financing bill includes measures to reduce spending on reimbursed drug costs, change the way that industry paybacks are calculated, and tackle medicine shortages.