Big Molecule Watch

Samsung Bioepis, Co. Ltd. and Biogen Inc. announced yesterday that their biosimilar product BYOOVIZ (ranibizumab-nuna) was approved by FDA.  BYOOVIZ is a biosimilar to LUCENTIS®, which is indicated for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.  As Biogen noted, BYOOVIZ is the first ophthalmology biosimilar approved in the United States. Samsung Bioepis’ and Biogen’s ranibizumab biosimilar was previously approved in the EU on August 18,…
Last week, results of Tanvex’s phase III study on its trastuzumab biosimilar candidate (TX05) were published in connection with the European Society for Medical Oncology’s (ESMO’s) Congress 2021.  The study compared the efficacy and safety of TX05 to Herceptin in patients with HER2+ early breast cancer.  The poster provides the following conclusions:  “The pCR risk ratio was within the predefined equivalence margins, confirming therapeutic equivalence of TX05 and Herceptin.  Secondary endpoints including ORR, safety and…
Last week, results of Tanvex’s phase III study on its trastuzumab biosimilar candidate (TX05) were published in connection with the European Society for Medical Oncology’s (ESMO’s) Congress 2021.  The study compared the efficacy and safety of TX05 to Herceptin in patients with HER2+ early breast cancer.  The poster provides the following conclusions:  “The pCR risk ratio was within the predefined equivalence margins, confirming therapeutic equivalence of TX05 and Herceptin.  Secondary endpoints including ORR, safety and…
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab).  Humira® is approved to treat certain inflammatory conditions.  Róbert Wessman, Founder and Chairman of Alvotech, announced, “We are delighted by the CHMP’s recommendation to approve our high-concentration biosimilar candidate for Humira.  Approval of AVT02 in the European Union would validate our global approach to biosimilar development.”  Mark…
On August 5, 2021, Formycon and Bioeq announced submission of the biologics license application for FYB201 to the U.S. Food and Drug Administration.  FYB201 is a biosimilar candidate to Lucentis(R)1 (Ranibizumab), which is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases.  If approved, Coherus Biosciences, Inc. will commercialize FYB201 (also known as CHS-201) in the United States according to the terms of a November 2019 license and development agreement…
On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO) “pursuant to Executive Order 14036, and in the hope of further developing the [FDA’s] engagement with the [USPTO].” Executive Order 14036 was issued by President Biden on July 9, 2021 and focused on…
Recently, JHL Biotech co-founders Racho Jordanov and Rose Lin pled guilty and were convicted of conspiring to steal trade secrets related to Genentech’s cystic fibrosis drug Pulmozyme, and cancer drugs Rituxan, Herceptin, and Avastin.  Although Jordanov and Lin initially pled not guilty, the former JHL employees later admitted to hiring former Genentech employees and using those employees’ knowledge of Genentech’s confidential information to advance JHL’s own biosimilar program.  Related to their conviction for trade secret…
On September 2, 2021, the parties in the Amgen v. Hospira (D. Del., No. 18-1064) Neupogen®/filgrastim litigation submitted a stipulation and proposed order to dismiss all claims and counterclaims in the litigation, with prejudice.  The Court (Judge Connolly) has not yet entered the order of dismissal on the docket. The case has been pending since July 2018.  Pfizer/Hospira obtained FDA approval for their biosimilar filgrastim product Nivestym® (filgrastim-aafi) in July 2018 and launched the…
Last week, Pfizer announced that it will acquire Trillium Therapeutics, a clinical stage immune-oncology company based in Cambridge, Massachusetts. Under the agreement, Pfizer reported that it “will acquire all outstanding shares of Trillium not already owned by Pfizer for an implied equity value of $2.26 billion, or $18.50 per share, in cash,” and its two lead molecules.  These molecules, TTI-622 and TTI-621, are SIRPα-Fc fusion proteins being developed across several indications, with a focus on…
Last week, Bio-Thera Solutions and Hikma Pharmaceuticals announced they have entered into an exclusive commercialization and license agreement to commercialize the proposed ustekinumab biosimilar product, BAT2206. According to the press release, Bio-Thera will “maintain responsibility for development, manufacturing, and supply of BAT2206 [and] Hikma will have exclusive rights to commercialize the product in the US.” The agreement also provides that “Hikma with a first-right-to-negotiate to add Europe (excluding CIS countries). Bio-Thera is eligible for…