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.

Amgen Files Reply in Support of Motion to Transfer Bevacizumab Action to California

We previously reported on Genentech’s complaint in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents and Amgen’s motion to transfer that complaint to the Central District of California. Today Amgen filed its reply (redacted) in support of transfer. In its reply, Amgen addresses Genentech’s…

Read More

Federal Circuit Affirms Invalidation of Patent Covering Remicade (infliximab)

As we previously reported, on ex parte reexamination, the Examiner rejected all claims of U.S. Patent No. 6,284,471, a patent covering Janssen’s Remicade® (infliximab), as invalid for obviousness-type double patenting (“OTDP”). The USPTO’s Patent Trial and Appeal Board affirmed the rejection and Janssen appealed the PTAB’s decision to the Federal Circuit. …

Read More

Brazilian Society of Clinical Oncology Publishes Position Statement on Biosimilars in Oncology

This month the Brazilian Society of Clinical Oncology (SBOC) published a position paper on approval and use issues concerning biosimilars in oncology. The paper, published in the Brazilian Journal of Medical and Biological Research, discusses “aspects related to definition, labeling/nomenclature, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and…

Read More

Alteogen reports similarity between its biosimilar ALT-L9 and Eylea®

South Korea’s Alteogen announced that its aflibercept biosimilar ALT-L9 had demonstrated similarity to the originator with no significant side effects in Michigan-based non-clinical trials. Aflibercept, known commercially as Eylea®, is sold by Regeneron for the treatment of wet age-related macular degeneration, which is the leading cause of blindness among the elderly….

Read More

First Etanercept Biosimilar to Receive Sales Approval in Japan

Last Friday, Japanese company Mochida Pharmaceutical with Korean company LG Chem announced that it has received sales approval from the Japanese Ministry of Health, Labour and Welfare on its etanercept biosimilar (marketed by Amgen as ENBREL®) for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis. LG Chem has a…

Read More

CD Cal Stays Dismissal of Amgen DJ Complaint Pending Delaware Decision on Genentech’s Motion to Transfer in MVASI® litigation

As we previously reported, on October 6, 2017, Amgen and Genentech filed separate lawsuits regarding Amgen’s bevacizumab biosimilar (MVASI®), with Amgen filing for declaratory judgment in C.D. Cal. of non-infringement, invalidity, and unenforceability of 27 patents, and Genentech filing a complaint for infringement of 24 patents in Delaware and a…

Read More

Samsung Bioepis’s Etanercept Biosimilar Said to be Less Immunogenic than Enbrel

A research letter published by the British Journal of Dermatology from investigators in Samsung Bioepis’s biosimilar etanercept (SB4) clinical trials reports that, in addition to therapeutic equivalence between SB4 and reference etanercept (Enbrel), SB4 has been found to be less immunogenic than reference etanercept.  The letter notes that injection site…

Read More

FDA Accepts Sandoz aBLA for Adalimumab Biosimilar

Sandoz, a division of Novartis, announced on Tuesday that the FDA has accepted for review its BLA under the 351(k) pathway for a biosimilar candidate to AbbVie’s Humira (adalimumab). According to the press release, adalimumab “is indicated for the treatment of a number of inflammatory diseases including rheumatoid arthritis, plaque psoriasis,…

Read More

Amgen’s Motion to Dismiss Genentech’s Complaint in the Delaware Mvasi Litigation

  As we previously reported, Genentech has filed two pending cases (Case Nos. 1:17-cv-01407 and 1:17-cv-01471) in the District of Delaware related to Amgen’s proposed Mvasi (bevacizumab-awwb), a biosimilar of Genentech’s Avastin.  On December 6, 2017, Genentech filed a sealed amended and supplemental complaint in Case No. 1:17-cv-01407, and on December 13, Genentech filed a redacted version.  Last month…

Read More

FDA Announces Release of 2018 Strategic Policy Roadmap

On January 11, FDA announced the release of its 2018 Strategic Policy Roadmap, which provides an overview of several policy areas that FDA intends to focus on in 2018.  FDA noted that, among these policy areas, it planned to “leverage innovation and competition to improve health care, broaden access, and…

Read More