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Samsung Bioepis and Merck Announce U.S. Launch of Trastuzumab Biosimilar

On Wednesday, Samsung Bioepis and Merck announced the U.S. launch of Ontruzant® (trastuzumab-dttb), a biosimilar to Herceptin® (trastuzumab).  Ontruzant® is indicated for the treatment of HER2-overexpressing breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, and is available in both 150 mg single-dose vials and 420 mg multiple-dose vials. …

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Biosimilar Market Updates

Shanghai Henlius biosimilar antibody developments On March 9, 2020, Shanghai Henlius Biotech, Inc. announced that its investigational new drug application has been accepted by China’s National Medical Products Administration (NMPA) for HLX14, a biosimililar to Amgen’s PROLIA (denosumab).  According to the press release, HLX14 is indicated for the treatment of…

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Rituximab Biosimilar Updates from Europe

Mabion We previously reported last month that applications for initial marketing authorization for two rituximab biosimilars were withdrawn from the European Medicines Agency (EMA), according to the Committee for Medicinal Products for Human Use (CHMP).  In particular, the EMA reported that these applications were withdrawn after the agency had evaluated…

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Partnership Updates

COVID-19 Delays Proposed Combination of Mylan and Upjohn Mylan N.V. and Pfizer Inc. have announced that unprecedented circumstances surrounding the COVID-19 pandemic will delay the proposed integration of Mylan and Upjohn, a division of Pfizer.  As we previously reported, Mylan and Upjohn, Pfizer’s off-patent branded and generic business, will combine…

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Special Master Appointed to Decide Requests to Seal and Redact in Genentech v. Amgen BPCIA Litigations

On March 30, in the Genentech v. Amgen trastuzumab and bevacizumab biosimilar patent litigations, Delaware District Judge Connolly ordered the appointment of a special master to handle the parties’ requests to seal various court filings.  Judge Connolly stated that “[r]ecent sealed and redacted filings in these related cases make clear that…

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