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Xbrane has announced it has resubmitted its BLA for its investigational biosimilar to Genentech’s Lucentis® (ranibizumab) with FDA.  Xbrane expects that there will be a ten-month review process and its candidate could be approved during the first half of 2024.  In July 2022...

Samsung Bioepis announced that it will present new data on its SB15 (proposed aflibercept biosimilar) at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, on 23 and 24 April 2023, including 56-week results from its Ph III trials.

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Sanofi and Regeneron announced that Health Canada issued a Notice of Compliance for Dupixent® (dupilumab) as a treatment of patients 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies ...

The US District Court of West Virginia has issued a claim construction order pertaining to seven claims of the four patents asserted in Regeneron’s BPCIA case against Mylan.  The four patents in suit (US Patent Nos. 10,888,601, 11,084,865, 11,253,572, and 11,104,715) are di...

Genentech and Roche announced that the FDA approved Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymph...

Taiho Oncology announced that the FDA accepted for Priority Review its supplemental new drug application (sNDA) for Lonsurf® (trifluridine/tipiracil) in combination with bevacizumab for metastatic colorectal cancer (mCRC).  The sNDA is based on results of a phase III clinic...

Samsung Bioepis released its first US Biosimilar Market Report which found that biosimilars will save the US healthcare system $181B in the next five years.  The report will be published each quarter after the Center of Medicare, Medicaid Services publishes new data.  Key f...

The US District Court of Delaware has ordered that Biogen Inc.’s and Biogen MA, Inc.’s Motion for Preliminary Injunction against Sandoz’s biosimilar natalizumab Tysabri® and the cross motions to strike is set down for an oral hearing on 17 May 2023 after the bri...