Welcome to the Big Molecule Watch!

ENGLISH | 中文

Goodwin’s award-winning Big Molecule Watch is the best resource for daily updates and analyses of regulatory issues, litigation, legislation, and other news in the world of biologics, biosimilars and related technologies. The editors of this blog have collectively been watching and engaging with the world of biologics and biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S.  With extensive experience representing clients at all stages of a biologic’s or biosimilar’s lifecycle, from research and development, to patents, to regulatory application and approval, and through litigation and appeals, we are excited to share our observations and insights as the industry and the law continues to develop in this exciting area.

This blog focuses on “big molecules” as opposed to “small molecules.” Small molecule drugs have low molecular weight, a simple and well-defined structure, and are chemically synthesized. In contrast, “big molecule” drugs have high molecular weight, complex structures, and are derived from living organisms. For example, aspirin is small molecule while a monoclonal antibody is a big molecule. For further reading on big molecules, consider FDA's resources on biologics.

IPR Updates

Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and Pfizer’s petitions (IPR2017-01488 and IPR2017-01489 [decisions under seal]) challenging Genentech’s Carter patent, U.S. Patent No. 6,407,213, directed to humanized antibodies.  This same patent…

Read More

Janssen's Infliximab Case Against Samsung Bioepis Dismissed

As we previously reported, Janssen and Samsung Bioepis jointly filed a stipulation of voluntary dismissal requesting that the District of New Jersey dismiss with prejudice Janssen’s patent infringement claims against Samsung Bioepis based on Samsung Bioepis’s filing of its aBLA for Renflexis® (infliximab-abda).  Samsung Bioepis launched Renflexis®, a biosimilar of Remicade®, in…

Read More

EMA Accepts Applications for Two Mylan and Biocon Biosimilars

On Friday, Biocon and Mylan announced that the European Medicines Agency has accepted applications for their proposed trastuzumab and pegfilgrastim biosimilars.  As we previously reported, Biocon had earlier requested withdrawal and resubmission of these applications, which it said was part of the EMA’s procedural requirements linked to the re-inspection of Biocon’s…

Read More

FDA Approves Ogivri, Mylan’s Biosimilar Version of Herceptin

Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab).  Ogivri is indicated for adjuvant treatment of breast cancer and treatment of metastatic breast cancer or stomach cancer in patients whose tumors overexpress the HER2 gene.  Ogivri is the first biosimilar version…

Read More

FDA Webinar To Discuss the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.

Next Tuesday (December 5) between 1:00-2:30pm (EST), FDA’s Division of Drug Information is presenting a webinar titled an “Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.”  The webinar will provide an overview of the regulatory framework for biosimilar products, “including a background,…

Read More