BiologicsHQ's "Spotlight On" product dashboards provide, at a glance, an overview of the status of U.S. patent proceedings. A new dashboard concerning tocilizumab (Actemra®, MSB11456, and BIIB800) is now available with activity through February 28, 2023.
March 14, 2023 LATEST NEWS Spotlight On: Actemra® (tocilizumab) BiologicsHQ's "Spotlight On" product dashboards provide, at a glance, an overview of the status of U.S. patent proceedings. A new dashboard concerning tocilizumab (Actemra®, MSB11456, and BIIB800) is now available with activity through February 28, 2023. Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo® (pegfilgrastim-bmez) / Nyvepria®(pegfilgrastimapgf) / Fylnetra™ (pegfilgrastim-apgf) / Stimufend® (pegfilgrastim-fpgk) Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb) / Trazimera® (trastuzumab-qyyp) / Kanjinti® (trastuzumab-anns) Spotlight On: Biosimilar Litigations Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximabpvvr) / Riabni™ (rituximab-arrx) Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) / Hadlima™ (adalimumab-bwwd) / Abrilada™ (adalimumab-afzb) / Hulio® (adalimumab-fkjp) / Yusimry™ (adalimumab- aqvh) / Idacio® (adalimumab-aacf) Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanerceptykro) Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin glargine-yfgn) / Rezvoglar™ (insulin glargine-aglr) BiologicsHQ's "Spotlight On" product dashboards provide, at a glance, an overview of the status of U.S. patent proceedings. The dashboards concerning pegfilgrastim (Neulasta®, Fulphila®, Udenyca®, Ziextenzo®, Nyvepria®, Fylnetra™, Stimufend®, Lapelga™, and Pegfilgrastim (Lupin)), trastuzumab (Herceptin®, Ogivri®, Herzuma®, Ontruzant®, Trazimera®, Kanjinti®, TX-05, EG12014, and HLX02), rituximab (Rituxan®, Truxima®, Ruxience®, and Riabni™), adalimumab (Humira®, Amjevita™, Cyltezo®, Hyrimoz™, Hadlima™, Abrilada™, Hulio®, Yusimry™, Idacio®, AVT02, and Yuflyma®), etanercept (Enbrel®, Erelzi®, and Eticovo®), and insulin glargine (Lantus® / Lantus® SoloSTAR®, Basaglar®, Semglee®, and Rezvoglar™) have been updated with activity through February 28, 2023. BiologicsHQ's "Spotlight On Biosimilar Litigations" dashboard provides, at a glance, an overview of the status of U.S. biosimilar patent litigations through February 28, 2023. Read More News UPDATES IPRs and PGRs Tysabri® (natalizumab): On February 2, 2023, the PTAB denied institution in Sandoz v. Biogen PGR2022-00054. Opdivo® (nivolumab): On February 6, 2023, Dana-Farber Cancer Institute filed IPR2023-00501 against ER Squibb & Sons. Eylea® (aflibercept): On February 10, 2023, Celltrion filed IPR2023-00532 along with a motion for joinder with IPR2022-01225 and IPR2023-00533 along with a motion for joinder with IPR2022-01226, against Regeneron. On February 10, 2023, Samsung Bioepis filed IPR2023-00566 along with a motion for joinder with IPR2022- 01226, against Regeneron. On February 28, 2023, Celltrion filed IPR2023-00620 against Regeneron. Enhertu® (fam-trastuzumab deruxtecan-nxki) / Adcetris® (brentuximab vedotin): On February 14, 2023, the PTAB granted the third request for rehearing of the institution decision in Daiichi v. Seagen PGR2021-00030 and instituted the PGR. Botox® (onabotulinumtoxinA): On February 21, 2023, Hugel filed IPR2023-00604 against Medy-Tox. PGR Filings Over Time by Technology PGR Institution Rates by Technology PGR Final Written Decision Outcomes − TC 1600 Skyrizi® (risankizumab-rzaa): On February 23, 2023, the PTAB denied Sandoz's request for rehearing of the PTAB's decision denying institution in PGR2022-00037 against Boehringer Ingelheim. Litigations Forteo® (teriparatide): On February 6, 2023, Eli Lilly and Dr. Reddy's consent judgment of noninfringement was entered in Case No. 1:22-cv-01354 (D. Del.). Herceptin® (trastuzumab): On February 10, 2023, Genentech v. Tanvex Case No. 3:22-cv-00809 (S.D. Cal.) was dismissed due to settlement. aBLA Applications and FDA Activity GP2411 (denosumab): On February 6, 2023, Sandoz announced the FDA acceptance of its aBLA for GP2411 (denosumab), a proposed biosimilar of Amgen's Prolia® / Xgeva® (denosumab). MYL-1402O (bevacizumab): On February 12, 2023, Viatris and Biocon announced receipt of a Complete Response Letter from the FDA related to the aBLA for MYL-1402O (bevacizumab), a proposed biosimilar of Genentech's Avastin® (bevacizumab). HLX02 (trastuzumab): On February 16, 2023, Accord BioPharma and Shanghai Henlius Biotech announced the FDA acceptance of the aBLA for HLX02 (trastuzumab), a proposed biosimilar of Genentech's Herceptin® (trastuzumab). Stimufend® (pegfilgrastim-fpgk): On February 17, 2023, Fresenius Kabi announced the launch of Stimufend® (pegfilgrastim-fpgk), a biosimilar of Amgen's Neulasta® (pegfilgrastim). CDER Purple Book Updates Lamzede® (velmanase alfa-tycv): On February 16, 2023, the FDA approved Chiesi Farmaceutici's Lamzede® (velmanase alfa-tycv). STATISTICS BiosimilarRelated IPR Petitions Biosimilar-Related IPR Petitions by Fiscal Year Biosimilar-Related IPR Petitions by Quarter Biosimilar-Related IPRs by Reference Product Biosimilar-Related IPRs: Number of Patents and Claims Challenged Status of BiosimilarRelated IPRs Biosimilar-Related IPRs: Institution and Final Written Decision Outcomes Biosimilar-Related Litigations by Year BiosimilarRelated Litigations Patents Subject to Biosimilar-Related IPRs and Litigations Biosimilar-Related Litigations by Reference Product Biosimilars and Interchangeables Approved in the United States Biosimilar and Interchangeable Applications Pending in the United States Patents Subject to Biologic Drug IPRs and Litigations Biologic Drug IPR Petitions Biologic Drugs Most Frequently Targeted in Serial IPR Challenges Number of IPR Challenges Per Biologic Drug Patent Biologic Drug IPRs by Reference Product Biologic Drug Patent Multiple IPR Challenges by Claim Type Robert S. Schwartz, Ph.D. Chair +1 212.218.2298 [email protected] Ha Kung Wong Partner +1 212.218.2571 [email protected] Contact the BiologicsHQ Team CALIFORNIA | DELAWARE | FLORIDA | ILLINOIS | MARYLAND | NEW YORK | VIRGINIA | WASHINGTON, DC © 2023 Venable LLP. This email is published by the law firm Venable LLP. It is not intended to provide legal advice or opinion. Such advice may be given only when it is related to specific fact situations that Venable has accepted an engagement as counsel to address. ATTORNEY ADVERTISING. Venable.com | Manage Preferences | Unsubscribe | If you are having trouble viewing this email, click here to view it in the browser or contact us by mail at Venable LLP, 600 Massachusetts Avenue, NW, Washington, DC 20001.