Supply Chain

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.

With the UK generics market facing a rising number of supply issues, local off-patent industry association the BGMA has put forward a raft of policy proposals that it said could provide solutions.

Toxic-Free Cosmetics Act planner Shari Franjevic acknowledges the Washington State Department of Ecology is authorized to use enforcement discretion regarding the new law’s 1ppm limit on trace lead in cosmetic products, effective 1 January 2025, or raise the ceiling via rulemaking. But it does not seem inclined to do either based on data known to the department at present. 

Indian CMOs, CDMOs and CRDMOs are expanding capacity and making leadership moves ahead of the BIOSECURE Act, anticipating demand from big pharma and budding biotechs. Scrip brings details on leading Indian firms which could be potential go-to suppliers for US companies affected by the proposed Act