Roche Holding was granted approval by the FDA for its Hemlibra, or emicizumab-kxwh, as a treatment for adult and pediatric patients with hemophilia A who have factor VIII inhibitors. The once-weekly administered drug, given via subcutaneous injection, is a preventive treatment for bleeding episodes in patients.
The CMS announced Thursday that it might allow Medicare drug plans to require that members get opioid prescriptions from selected prescribers and fill them only at certain pharmacies as part of measures to fight the opioid abuse epidemic. The agency is also considering requiring payers to pass on drug discounts to consumers, treating out-of-pocket costs for biosimilars like generic drugs and permitting midyear formulary changes after a lower-cost generic drug enters the market. The proposal is open for comments until Jan. 16.
Biosimilars hold the promise of reducing drug costs, but regulatory and patent issues remain obstacles to their adoption. "Less than half the number of biosimilars that have been approved in the United States by the FDA are currently on the market, and the reason for that is the other ones are still tied up in litigation," said Chip Davis, CEO of the Association for Accessible Medicine.
Using Cue Biopharma's Cue Biologics platform, the company will work with Merck to develop treatments for autoimmune diseases. Under the terms of the collaboration, Cue will get an undisclosed upfront payment and is eligible for up to $374 million in milestones, plus royalties.