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.
completion of initial phases of the Biologic Price Competition and Innovation Act patent exchange with Amgen for its pegfilgrastim biosimilar candidate CHS-1701. Coherus reported that it has received a complete response […]
In response to Coherus’s motion to stay discovery
in Amgen v. Coherus
, Amgen filed an answering brief
yesterday opposing this motion. Amgen claimed that any delay in the proceedings would “unduly prejudice […]
Below are some highlights from second quarter earnings reports recently released by biologics and biosimilar companies. Coherus reported
that it has cash and cash equivalents of $118.3 million as of June 30, 2017 and that […]
In its Q2 2017 Earnings Call
last week, Momenta reported that it continues to work towards a first submission for approval of its wholly owned HUMIRA biosimilar, M923, with a possible commercial launch by 2020. […]
Yesterday during Regeneron Pharmaceutical’s Q2 earnings call
, Regeneron announced that its Antibody Discovery Agreement with Sanofi will be ending on December 31, 2017 without an extension. Regeneron’s President and Chief Scientific Officer, George […]
Today, AbbVie filed a complaint
against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA
for a biosimilar version of AbbVie’s […]
Last week, Boehringer Ingelheim announced
that it had enrolled the first patient into its VOLTAIRE-X interchangeability study
. This Phase 3 study will investigate the interchangeability of BI’s adalimumab biosimilar candidate, BI 695501, and Humira® […]
Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric […]
Novartis recently released its Q2 2017 financials, which included updates on various biosimilar products in its subsidiary Sandoz’s pipeline. Pegfligrastim As we previously reported
last July, the FDA last year issued a complete response […]
The Board granted Hospira a mixed result in its numerous challenges to Genentech’s patents directed to different aspects of Genentech’s trastuzumab product: The Board instituted IPR of U.S. Patent No. 7,371,379 (IPR2017-00805
), U.S. […]