A recent bidding war on a government tender in Norway for an infliximab biosimilar resulted in a 69 percent discount from the innovator and a rapid market uptake of the follow-on, proving that physicians and patients will flock to a biosimilar – if the price is right.
Despite the challenges of being a biologic pioneer, Amgen Inc.'s melanoma drug, talimogene laherparepvec, or T-vec, garnered the support of two FDA advisory committees with some caveats.
After months of bipartisan negotiations, a House subcommittee yesterday released its 2.0 discussion draft of the 21st Century Cures Act that fills one of the holes in the first version released in January – provisions to bolster funding for the National Institutes of Health (NIH).
In an ongoing quest to find ways to reduce the cost and time of getting innovative drugs and devices from conception to patients, the Senate Health, Education, Labor and Pensions (HELP) Committee Tuesday asked the FDA and NIH for practical suggestions.
More than a month after approving Sandoz Inc.'s Zarxio as the nation's first biosimilar, the FDA Tuesday issued final versions of the first three draft guidances it released on biosimilars in 2012.
Drugmakers are lining up on both sides of the dance floor as the Federal Circuit prepares to hear arguments June 3 in Amgen Inc. v. Sandoz Inc. – the outcome of which could determine when Sandoz launches Zarxio as the first biosimilar in the U.S.
Exceeding expectations, the success of the breakthrough therapies program has the FDA and patient advocates calling on industry to exercise self-control in requesting the designation, which grants expedited development and review.