Teva’s dream of a smooth summer launch for its Alvotech-partnered Humira biosimilar is in jeopardy after its Icelandic compatriot weathered a second FDA snub in less than a year. Manufacturing ...

Please provide your email address to receive an email when new articles are posted on . The complete response letter cites facility issues in denying the biosimilar. The approval process had been on ...

Alvotech (NASDAQ:ALVO) shares dropped ~7% pre-market Thursday after the Iceland-based drugmaker said that the FDA declined to approve AVT02, a biosimilar candidate to AbbVie (ABBV) blockbuster ...

The FDA has accepted the supplemental biologics license application for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira, from Organon (NYSE:OGN) and Samsung ...

Medicare Part D may cover Humira when a person can self-administer it at home. A person’s Part D costs for Humira will depend on the plan’s formulary and their specific plan. Similarly, Medicare ...

Tennessee last year spent $48 million on a single drug, Humira — about $62,000 for each of the 775 patients who were covered by its employee health insurance program and receiving the treatment. So ...