Past year was the high-water mark for product approvals and launches, but complete response letters remain a frequent occurrence. FDA’s ability to deliver on its promise of further clarity on transition products, interchangeability and indication carve-outs/carve-ins may take a hit from the ongoing partial government shutdown. On the legal side, look for more patent settlements with staggered entry dates and new antitrust scrutiny.
Last year saw a watershed in the US biosimilars space, with a record number of approvals and launches, new regulatory strategies employed by 351(k) applicants trying to get around patent issues, and new guidance for products that will make a sudden and dramatic shift from drug to biologic regulation in March 2020.
However, 2018 also saw a continuing spate of FDA complete response letters (CRLs) and an ongoing lack of clarity