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.
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. […]
Sanofi-Aventis has filed a petition
for IPR of Immunex Corporation’s U.S. Patent 8,679,487, directed to isolated human antibodies that compete with a reference antibody for binding to human interleukin-4 (IL-4) receptor. The proceeding has been […]
Earlier this week Coherus filed a motion to stay
the BPICA litigation brought by Amgen in the District of Delaware, arguing that in light of the FDA’s complete response letter delaying the launch of […]
The White House released a statement of administration policy
on July 12 in response to the House of Representatives passing H.R. 2430, a bill that would reauthorize […]
As we previously reported, following the Supreme Court’s decision
in Sandoz v. Amgen
, Sandoz requested a remand
to the District Court to answer the two questions that the […]