Tagged as: Biosimilars News

Biosimilar Regulatory Submission Updates: Europe, U.S., Japan, Canada

Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines.  In addition to yesterday’s news about the U.S. FDA’s approval of Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) biosimilar product, below are some highlights: On June 1, the Committee for Medicinal Products for Human Use…

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Q1 2018 Earnings Roundup: Biosimilars Update

Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls.  Below are some highlights: On April 17, Johnson & Johnson (J&J) reported a 22.5% year-over-year (YOY) decline in U.S. sales of Remicade® (infliximab), which it attributed “to increased discounts/rebates,…

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Global Biosimilar Development Updates

Over the past week, biopharmaceutical developers from around the world provided updates on the development and availability of a number of biosimilar products and candidates.  Below are some highlights. On May 2, Mundipharma, a global network of independent associated companies, announced that the trastuzumab biosimilar Herzuma® is now available in…

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Litigation Updates on Pegfilgrastim and Dupilumab

Pegfilgrastim litigation  We had previously covered Judge Stark’s grant of Coherus’s motion to dismiss Amgen’s complaint alleging infringement of the ‘707 patent in Amgen v. Coherus. Today, Judge Stark entered judgment against Amgen and dismissed the case. In the Amgen v. Mylan litigation earlier covered here, Mylan recently filed a…

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AbbVie and Samsung Bioepis Announce Global Settlement of Adalimumab Disputes

Today, AbbVie and Samsung Bioepis announced that they have reached a global resolution of all intellectual property-related litigation relating to Samsung Bioepis’ biosimilar of Humira® (adalimumab), SB5, clearing the way for its commercialization in all approved markets worldwide.  SB5 has already received marketing authorization from the European Commission (EC) as…

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