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Coherus and Junshi Biosciences Announce FDA Acceptance of Toripalimab BLA

Last week, Coherus and Junshi Biosciences announced that the FDA accepted their BLA for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after…

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Innovent Announces the Approval of a First-Line Therapy for People with Hepatocellular Carcinoma in China

Innovent Biologics, Inc. announced that the National Medical Products Administration of China (“NMPA”) approved its supplemental New Drug Application for TYVYT®, a sintilimab injection, in combination with BYVASDA®, a bevacizumab biosimilar injection, as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (“HCC”).  According to the press release,…

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Quebec Government Announces Shift to Biosimilar Drugs

On May 18th, Christian Dubé, the Minister of Health and Social Services for Quebec announced that the government will begin a shift in favor of the use of biosimilar drugs.  The announcement stated that similar to other Canadian jurisdictions, Quebec will eventually cover, with exceptions, only biosimilar drugs on the…

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Plantform and Bio-Manguinhos/Fiocrus to Partner on Pembrolizumab Biosimilar for Brazil

Last week, PlantForm Corporation, PlantPraxis Biotecnologia and Bio-Manguinhos/Fiocruz announced that they are entering into a research and development agreement to develop pembrolizumab, a biosimilar of Keytruda®, for the Brazilian Market.  According to the announcement, Bio-Manguinhos is a Brazilian government institution responsible for technology development and production of vaccines, reagents and…

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7th Circuit Evaluates the "Patent Thicket"

Last week the 7th Circuit Court of Appeals heard arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402.  The appeal concerns the United States District Court for the Northern District of Illinois’ dismissal of a proposed class action alleging that AbbVie, Inc. created a “patent thicket”…

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