Tagged as: Canada

Celltrion Shares Recent Biosimilar Development News

Celltrion Healthcare announced last week that it received positive results from the Phase III trial of its high-concentration, low-volume, citrate-free adalimumab biosimilar, CT-P17 or Yuflyma™, in patients with active rheumatoid arthritis (RA).  According to the press release, “[r]esults demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients…

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Global Biosimilar Update

The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe.  As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or rectal carcinoma, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian cancer, fallopian tube…

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Global Biosimilars Approval and Launch Updates

Shanghai Henlius Biotech, Inc. announced on August 14, 2020 the approval of its trastuzumab biosimilar HLX02 by the National Medical Products Administration (NMPA).  This same product was approved by the European Commission on July 27th.  According to the press release, this is the the first China-developed mAb biosimilar to be…

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TPP Updates: Japan and Canada Begin Deliberations on Trade Deal Ratification

Since the TPP’s signing by twelve Pacific Rim countries this past February, the agreement has been making its way through the “next phase” of its development—ratification through the signatory countries’ “respective domestic processes.”   As we’ve covered previously (see our posts here and here), if enacted, the TPP’s intellectual property provisions…

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