Drug Review

Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.

Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu

The FDA plans to implement generative AI for drug reviews by 30 June 2025, enhancing efficiency and potentially accelerating approval processes. Discussions with OpenAI about AI integration are ongoing.

In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.

With Sandoz set to debut US competition to Prolia and Xgeva in a matter of months, other biosimilar sponsors are working hard to ensure launch of Amgen’s blockbuster in a timely manner.

Ahead of the first biosimilars to denosumab emerging later in the spring, the market is continuing to prove enticing, with Amneal the latest to file for biosimilars to Prolia and Xgeva.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Having picked up Niemann-Pick disease type C drug Miplyffa for a song, the US rare disease specialist is singing all the way to the bank after selling the priority review voucher that came with its approval.