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.
According to press releases this week, the FDA has recently accepted two new Abbreviated Biologics License Applications (aBLA) for review. First, Adello Biologics yesterday announced
that the FDA has accepted its aBLA for its […]
Yesterday, in the remanded appeal
in Amgen v. Sandoz
, the United States submitted an amicus brief
to the Federal Circuit that generally supports the position taken by Sandoz
and the Biosimilars Council
With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira
last week denied
Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit® (epoetin alfa) […]
Last week Fresenius Kabi announced that it has successfully closed its acquisition of Merck KGaA’s biosimilars business, which comprises Merck’s entire biosimilars development pipeline. According to Fresenius, the product pipeline is focused on oncology and autoimmune […]
The Federal Circuit has scheduled the oral argument
of Amgen’s appeal
from the district court’s judgment of non-infringement
of Apotex’s proposed biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) for 2:00pm on […]
As we’ve posted here
, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (pegfilgrastim) and Ogivri (trastuzumab), and have filed applications for marketing authorization in the European Union (EU) and the […]
Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart
or our previous quarterly updates (Summer 2016
that its proposed adalimumab (Humira) biosimilar candidate demonstrated clinical equivalence on all endpoints compared to the European marketed Humira. The candidate in this study also did not show any clinically meaningful difference in […]
Samsung Bioepis has filed three petitions for IPR challenging Genentech patents related to the use of Herceptin® (trastuzumab): IPR2017-01958
, challenging U.S. Patent 6,627,196; IPR2017-01959
challenging U.S. Patent 7,371,379; and IPR2017-01960
As we previously reported
, following the Supreme Court’s June 12, 2017 decision in Sandoz v. Amgen
, the Federal Circuit on July 26, 2017, issued an order
recalling its October 23, […]