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.
Today, FDA approved
Samsung Bioepis’s aBLA for RENFLEXIS® (infliximab-abda), a biosimilar of Janssen’s REMICADE®. According to the approved prescribing information
, RENFLEXIS® is indicated for the treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative […]
More states continue to enact laws regarding the substitution of biosimilars for prescribed biological products. We have previously reported on the enactment of such laws in New Jersey
. On […]
Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing
, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS
is a provision […]
Celltrion announced last week that it has filed
for marketing approval of Herzuma (trastuzumab) with Japan’s Ministry of Health, Labor and Welfare. Herzuma is indicated for the treatment of breast and gastric cancers. This would be […]
On April 14, Amgen filed its reply brief in Sandoz v. Amgen
. We have previously reported on Sandoz’s response and reply brief
, Amgen’s consolidated opening and responsive brief
and Sandoz’s opening brief
We have previously reported
on letters submitted by Genentech and Amgen to the District of Delaware regarding Genentech’s decision not to file an amended complaint. In its letter, Genentech requested entry of judgment without […]
The House and Senate Committees released a draft bill
on Friday to reauthorize user fee programs for biosimilars, pharmaceuticals, generic drugs, and medical devices from 2018 to 2022. The bill states that the fees […]
As we reported
on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s application to market a biosimilar […]
As we previously reported
, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen
, finding a lack of subject matter jurisdiction over Genentech’s declaratory judgment complaint under the Federal Circuit’s holding […]
On March 31, Sandoz filed its consolidated response and reply brief
in Sandoz v. Amgen
. We have previously covered Amgen’s consolidated opening and responsive brief
and Sandoz’s opening brief
. Amgen’s final reply brief was filed […]