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.

Review Article Supports Interchangeability of Infliximab and CT-P13

BioSimilars Patent Dance

Last week, an article reviewing the literature comparing infliximab biosimilar CT-P13 (Celltrion) with infliximab (Janssen Biotech) for the treatment of rheumatologic diseases was published in Drug Design, Development and Therapy. Noting that many European specialists had reported having only a basic knowledge of biosimilars, the authors sought to critically analyze…

Read More

PTAB Issues Additional Final Written Decisions Finding AbbVie's Humira Patent Unpatentable

On July 6, 2017, the PTAB issued two additional Final Written Decisions finding AbbVie’s U.S. Patent 8,889,135 (“the ‘135 patent”) unpatentable as obvious over the prior art.  The Final Written Decisions were issued in IPR2016-00408 and IPR2016-00409, both filed by Boehringer Ingelheim.  As we reported here, the ‘135 patent had previously been found unpatentable as…

Read More

Pfizer Files Two Petitions for IPR of Genentech's Trastuzumab Patent

Pfizer has filed two petitions for IPR of U.S. Patent 8,591,897, owned by Genentech: IPR2017-01726 and IPR2017-01727.  According to the petitions, the ‘897 patent is directed to methods for treating patients with non-metastatic HER2-positive breast cancer by administering anthracycline/cyclophosphamide (AC) based chemotherapy, followed by sequential administration of a taxoid and…

Read More

Discontinuation of Etanercept Biosimilar in Japan

On July 5, 2017, Daiichi Sankyo Company announced that it has decided to discontinue the development of CHS-0214, an investigational biosimilar to Amgen’s Enbrel® (etanercept), in Japan.  Daiichi had been co-developing CHS-0214 with Coherus BioSciences, who still holds rights to CHS-0214 outside of Japan.  According to the announcement, CHS-0214 had…

Read More

Update On Amgen’s PI Motion In Amgen v. Hospira

Yesterday, in Amgen v. Hospira, Amgen filed a redacted copy of Amgen’s amended opening brief in support of its motion for preliminary injunction (PI).  As we previously reported, Amgen filed a revised brief because the Supreme Court’s decision in Sandoz v. Amgen impacted the issues raised in Amgen’s original PI motion. Amgen’s…

Read More