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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...

AbbVie announced that the European Commission has approved Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or areintolerant to either conventional therapies or bio...

The Korean Biomedical Review reported that Celltrion has launched Vegzelma®,  biosimilar to Genentech’s Avastin® (bevacizumab), in the US .

Celltrion received FDA approval for Vegzelma® in September 2022 for the treatment of six types of cancer.

The District Court of West Virginia denied Mylan’s emergency motion seeking orders which would require Regeneron to immediately narrow the scope of its infringement proceedings to 12 claims of 3 patents. As it currently stands, Regeneron is required to narrow the scope of t...

Alvotech announced that it received (in March) and responded to (in April) a complete response letter from the FDA regarding its BLA for high concentration (buffer free) formulation of AVT02, biosimilar to AbbVie’s Humira®, and is awaiting the FDA’s assessment of its respon...