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Pearce IP | Australia | 3 Dec 2021

Pearce IP BioBlast®: w/e 03 December 2021

Tot Biopharm announced that China’s NMPA has approved Pusintin® (biosimilar bevacizumab) for the treatment of patients with advanced, metastatic or…
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Pearce IP | Australia | 26 Nov 2021

Pearce IP BioBlast®: w/e 26 November 2021

Innovent released the results of a Ph III study of sintilimab and BYVASDA® (bevacizumab biosimilar) combined with chemotherapy in patients with…
Commentary
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Smart & Biggar | Canada | 10 Nov 2021

Update on biosimilars in Canada – October 2021

Since April 2021, there have been many developments regarding biosimilars in Canada. This article provides an overview of the most important developments, which include approvals, pending submissions, litigation, regulatory developments and market access.
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Pearce IP | Australia | 8 Nov 2021

Pearce IP BioBlast®: w/e 05 November 2021

The International Generic and Biosimilar Medicines Association called on all stakeholders ahead of its second Global Biosimilars Week to…
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Pearce IP | Australia | 2 Nov 2021

Pearce IP BioBlast®: w/e 29 October 2021

Janssen announced data from two new analyses of Stelara® (ustekinumab) for the treatment of adults with Crohn’s disease and ulcerative colitis…
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Pearce IP | Australia | 11 Oct 2021

Pearce IP BioBlast®: w/e 08 October 2021

Apobiologix announced that Health Canada has approved Bambevi® (biosimilar bevacizumab) in combination with chemotherapy to treat specific types of…
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Bergeson & Campbell PC | USA | 28 Sep 2021

FDA Issues Revised Final Guidance On Biosimilar Development And The BPCI Act

On September 20, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of its revised final Guidance for Industry on biosimilar…
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Kramer Levin Naftalis & Frankel LLP | USA | 22 Sep 2021

Northern District of Illinois Holds That a Biosimilar Applicant Is Not a Necessary Party to a BPCIA Lawsuit

On Aug. 23, 2021, the U.S. District Court for the Northern District of Illinois denied Alvotech hf.’s motion to dismiss AbbVie’s biosimilar lawsuit…
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Pearce IP | Australia | 20 Sep 2021

Pearce IP BioBlast®: w/e 17 September 2021

Samsung Bioepis reported on a five-year follow-up study comparing ONTRUZANT® (trastuzumab biosimilar) with reference trastuzumab in early or locally…
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Pearce IP | Australia | 16 Aug 2021

Pearce IP BioBlast: Updates for w/e 13 August 2021

A new study reported that the safety profiles and pharmacokinetic parameters of Amgen’s ABP980 (biosimilar trastuzumab) and pertuzumab administered…
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