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.

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

Revance Therapeutics, Mylan, and Formycon Announce Updates to Their Biosimilar Plans

Revance Therapeutics, Mylan, and Formycon have announced updates to their biosimilar plans.  In the Q1 2020 Earnings Conference Call on May 7, 2020, Revance updated investors on the biosimilar to BOTOX® program in potential partnership with Mylan.  Revance informed investors that Mylan had requested additional information from Revance, and would…

Read More

Samsung Bioepis Announces Four-Year Follow-Up Data for its Trastuzumab Biosimilar and 24-Week Interim Results from Phase 3 Trial of its Proposed Ranibizumab Biosimilar

Samsung Bioepis Co., Ltd. announced on Friday that the four-year follow-up data from a Phase 3 study for ONTRUZANT, a biosimilar of HERCEPTIN (trastuzumab), will be presented later this month at the ASCO20 Virtual Scientific Program.  The data are from an ongoing five-year follow-up study assessing the cardiac safety and…

Read More

Study Says that Conversion of Intermediate-Risk FN Patients to Pegfilgrastim Biosimilar Likely to Have Large Budget Impact

A new study funded by Sandoz related to the budget impact of expanding patient access to biosimilar pegfilgrastim (Ziextenzo) was presented during the Academy of Managed Care Pharmacy’s AMCP eLearning Days virtual meeting in April. The study found that expanding access to Ziextenzo to patients with intermediate risk of developing febrile…

Read More