Welcome to the Big Molecule Watch!

ENGLISH | 中文

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.

Supreme Court Denies Cert on 5th Amendment Constitutionality of Subjecting Pre-AIA Patents to IPR

Today, the Supreme Court denied three petitions for certiorari challenging the constitutionality of subjecting patents issued prior to the America Invents Act (“AIA”) to inter partes review (“IPR”).  See Celgene v. Peter; Collabo v. Sony Corp.; Enzo v. Becton, Dickinson and Company.  In all three underlying cases, the U.S. Court of Appeals for the Federal Circuit had…

Read More

FDA Approves First New Biosimilar of 2020

On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved Pfizer’s NYVEPRIA (pegfilgrastim-apgf), a biosimilar of Amgen’s NEULASTA. NYVEPRIA is indicated to “decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of…

Read More

Alexion and Amgen Settle IPRs Over SOLIRIS (eculizumab)

Alexion Pharmaceuticals’ SOLIRIS (eculizumab) is approved in the U.S. for the treatment of paroxysmal nocturnal hemoglobinuria (PHN), atypical hemolytic uremic syndrome (aHUS), myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).  Amgen’s ABP 959 is a biosimilar to SOLIRIS undergoing clinical trials with a phase 3 clinical trial initiated earlier…

Read More

Biosimilars Approvals: Nepexto Receives European Marketing Authorization, Ziextenzo and Riximyo Receive Health Canada Approval

Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product.  The marketing authorization follows a positive opinion from the Committee for Medicinal Products for Human Use earlier this year based on preclinical and clinical…

Read More

Henlius and Accord Announce EMA Recommendation for Marketing of Their Trastuzumab Biosimilar

We previously reported on Shanghai Henlius’s (“Henlius”) biosimilar developments, including their announcement of an exclusive license agreement with Mabxience Research, S.L. to develop and commercialize their trastuzumab biosimilar, HLX02. This week, Henlius jointly announced with Accord Healthcare Limited that the Committee for Medicinal Products for Human Use (CHMP) of the…

Read More

PTAB Issues Final Written Decisions Finding Most Claims of Sanofi’s Lantus Patents Invalid

As we previously reported, Mylan filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection).  On May 29, 2020, the PTAB issued Final Written Decisions in eight of Mylan’s pending petitions concerning four patents finding most of the challenged claims…

Read More