Welcome to the Big Molecule Watch!
Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.
If you’re looking for a primer on biologics, check out our background post
introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).
We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.
In its 2018-2022 National Health Strategy
, France aims for 80% biosimilar penetration by 2022, an increase from last year’s 70% target. France’s support for biosimilars is not new. Its 2014 budget pushed for pharmacy-level […]
On January 8, 2018, the Federal Circuit issued its en banc decision
in Wi-Fi One, LLC v. Broadcom Corp
., No. 2015-1944. The Federal Circuit originally held that due to binding precedent, a time-bar determination […]
Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study
presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that there were no clinically […]
It has been reported that manufacturer AbbVie will increase
the price of Humira® (adalimumab) by 9.7% in 2018. According
to Wells Fargo analyst David Maris, this price increase could add an additional $1.2 […]
Hetero announced this week
the launch in India of its adalimumab biosimilar, marketed under the brand name Mabura. Mabura is a biosimilar of Abbvie’s Humira and is indicated […]
As we reported previously,
Amgen is seeking en banc review of the Federal Circuit panel decision vacating
a permanent injunction
that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanding the […]
We previously posted that in August 2017, Samsung Bioepis’ adalimumab biosimilar, SB5 (also known as Imraldi®), was granted marketing authorization
by the European Commission. In September, it also won approval
from the South […]
Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development
.” The guidance is intended to “describe best […]
Yesterday, Momenta Pharmaceuticals
announced a development strategy for M710, a proposed biosimilar of Regeneron’s Eylea® (aflibercept), including their plan to initiate a pivotal clinical trial in the first half of this year. […]
As we frequently report here on the blog, there has been increasing activity in BPCIA litigation concerning a variety of proposed and marketed biosimilar products. The coming year is likely to bring even more activity, with […]