Infliximab-abda gains FDA licensure without having faced an advisory committee review; under current case law, launch could come as early as mid-October.
Samsung Bioepis Co. Ltd.’s Renflexis (infliximab-abda), approved by FDA April 21, becomes the fifth biosimilar licensed in the US but still has its share of firsts.
It is the first biosimilar approved by FDA without an advisory committee review. It’s also the first time in the nascent US market that a single novel biologic (in this case, Janssen Biotech Inc
In addition, the Renflexis approval comes in the apparent absence of patent litigation between the biosimilar and reference product
Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.
The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.
