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Celltrion’s Bevacizumab Biosimilar Approved by FDA

Celltrion announced this week that the FDA has approved VEGZELMA (bevacizumab-adcd), a biosimilar to AVASTIN, for treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian…

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EMA Adopts Positive Opinion for STADA and Xbrane’s Ranibuzumab Biosimilar Candidate XIMLUCI®

On Sep 16, 2022, Partners STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (publ) (“Xbrane”) announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for XIMLUCI®.  XIMLUCI® is a biosimilar candidate referencing LUCENTIS® (ranibizumab), which is an anti-VEGF (vascular endothelial…

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Lupin Announces Approval of ENBREL Biosimilar in Canada

On September 13, 2022, Lupin Ltd. (“Lupin”) announced that its RYMTI product, a biosimilar to ENBREL (etanercept), has been approved in Canada.  Lupin, based in Mumbai, India, specializes in cardiovascular, diabetic, and respiratory disease treatments.  RYMTI is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial…

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Executive Order for Advancing Biotechnology and Biomanufacturing Innovation Signed by President Biden

On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order is to “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food…

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Formycon Announces Details for Pembrolizumab Biosimilar

This week Formycon AG (“Formycon”) announced details of its previously undisclosed pipeline project for FYB206, Formycon’s biosimilar of KEYTRUDA (pembrolizumab). KEYTRUDA is approved for the treatment of advanced melanoma, lung and other types of carcinoma. According to the press release, Formycon fully owns the development and commercialization rights for FYB206,…

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European Regulatory Heads Make Biosimilars Interchangeable

On September 19, 2022, the European Medicines Agency’s (“EMA”) Biosimilar Medicines Working Party (“BMWP”) and the Heads of Medicines Agencies (“HMA”), a network of the heads of the authorities responsible for the regulation of medicinal products for human use in the European Economic Area, issued a Joint Statement confirming that…

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Genentech and Samsung Bioepis Settle Bevacizumab Biosimilar Patent Dispute

As we previously reported, on June 28, 2020, Genentech, Inc. (“Genentech”) filed a complaint against Samsung Bioepis Co., Ltd. (“Samsung”) in the District of Delaware, alleging infringement of fourteen patents under the BPCIA based on Samsung’s submission of an aBLA for SB8, a proposed biosimilar of AVASTIN (bevacizumab). On September 7, 2022, Genentech and Samsung filed…

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Regeneron Seeks Expedited Trial in BPCIA Case Against Mylan Regarding Aflibercept Biosimilar

As we previously reported, Regeneron filed a BPCIA complaint against Mylan on August 3, 2022, regarding Mylan’s proposed aflibercept biosimilar.  Just two days after filing its Complaint, Regeneron filed a motion requesting an expedited status conference and to schedule a trial for no later than June 2023.  Briefing on Regeneron’s…

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Biogen Files Sealed Complaint Against Sandoz and Polpharma Biologics Regarding Natalizumab

On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics.  Biogen’s complaint is filed under seal.  Based on the list of 28 asserted patents, the case appears to be a BPCIA litigation related to Sandoz and Polpharma’s proposed natalizumab biosimilar.  The asserted…

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