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Celltrion Announces Phase III Results for Aflibercept Biosimilar

On April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42 (aflibercept), a biosimilar referencing Regeneron’s EYLEA.  The trial is a 52-week trial in 348 patients with diabetic macular edema (DME) across thirteen countries. The primary endpoint was the change in best corrected…

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FDA Commissioner Delivers Remarks at FDA-U.S. Patent and Trademark Office Public Workshop

On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop.  He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA and USPTO have been working together to leverage their combined expertise to promote competition and access…

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An Interview with Rachel Goode, Ph.D, about Biological Patent Thickets

Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to biosimilars, an American problem.”[1]  The article, published in the Journal of Law and the Biosciences, examines whether patent…

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Amgen Releases 2022 Biosimilar Trends Report

On October 12, 2022, Amgen released its 2022 Biosimilar Trends Report. Since we posted on Amgen’s report preview in July, the total number of biosimilars that have been approved in the United States has increased from 36 to 39 (with the approval of Coherus’s CIMERLI (ranibizumab-eqrn) in August and Fresenius…

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Biocon and Alvotech Release Statements on FDA Inspections

On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia.  The inspections took place between August 11 and August 30, 2022.  The inspections were triggered by three preapproval inspections…

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FDA Accepts for Review Fresenius Kabi’s BLA for Tocilizumab Biosimilar

On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab).  The BLA includes both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.  This is the first BLA accepted by FDA for a tocilizumab biosimilar. …

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Formycon Q1 2022 Financial Results - Big Molecule Watch

First Quarter Earnings Graphic

Formycon recently announced its sales and earnings figures for the first quarter of 2022.  Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -4.0 million (Q1/previous year: EUR -1.7 million), which was in line with expectations.  According to the press release, the reported revenues were mainly a result…

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EMA Recommends Denying Marketing Authorization for Prestige BioPharma’s TUZNUE and HERVELOUS (trastuzumab) (UPDATE – 5/27/2022)

European Medicines Agency

On May 19, 2022, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued opinions recommending the refusal of marketing authorization for Prestige BioPharma Ltd.’s HD201, TUZNUE and its duplicate HERVELOUS, proposed trastuzumab biosimilars of Roche’s HERCEPTIN. TUZNUE and HERVELOUS are intended for the treatment of…

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FDA Approves Amneal’s ALYMSYS (bevacizumab-maly)

On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN.  The product will be marketed under the proprietary name ALYMSYS and represents the third bevacizumab biosimilar approved in the U.S, following Pfizer’s ZIRABEV (bevacizumab-bvzr) in 2019 and Amgen’s MVASI…

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