Tagged as: Biosimilars News

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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US FDA Issues CRL for Sandoz’s Rituximab Biosimilar Candidate

Yesterday, Sandoz announced that the FDA has issued a Complete Response Letter (CRL) regarding its aBLA for its proposed biosimilar of Rituxan® (rituximab).  Sandoz states that it “stands behind the evidence that it submitted to the FDA and that, “[w]hile disappointed, Sandoz remains committed to further discussions with FDA in…

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Pfizer Receives Complete Response Letter from FDA for Trastuzumab aBLA

Today, Pfizer announced that it received a Complete Response Letter (CRL) from the FDA in response to Pfizer’s application for its proposed biosimilar of Herceptin® (trastuzumab).  According to Pfizer’s press release, the CRL “highlighted the need for additional technical information,” but the “requested information does not relate to safety or…

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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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Wisconsin and West Virginia Pass Biosimilar Legislation

Last week, both Wisconsin and West Virginia passed legislation intended to facilitate the dispensing and substitution of biosimilar products.  Wisconsin and West Virginia join Michigan, which enacted House Bill 4472 on February 28, as the latest states to approve biosimilar access bills. On Wednesday, Wisconsin Governor Scott Walker signed Senate…

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Recent Biosimilar Industry Coverage

A number of media sources have covered new developments in the biosimilars space.  Here is a round-up of some highlights from this month. Reuters reports that biosimilars, including biosimilar versions of Rituxan and Herceptin, have begun to capture a large portion of the British biosimilar market, whereas approvals and adoptions…

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