Tagged as: Mylan

Biosimilars Development Updates: Mylan’s Pipeline, Coherus’s Adalimumab aBLA, Amgen’s Eculizumab Biosimilar

Mylan announced on its most recent quarterly earnings call that it expects to launch its rituximab and etanercept biosimilars in Europe later this year. In discussing Mylan’s biosimilars pipeline, Rajiv Malik, Mylan’s President, told market analysts, “we also have for Europe rituximab and Enbrel biosimilars, which will be most likely…

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Amgen Drops Assertion of One Patent Against Mylan in Pegfilgrastim Biosimilar Litigation; One Patent Remains

As we previously reported, in the Amgen v. Mylan litigation concerning Mylan’s FULPHILA (pegfilgrastim-jmdb), a biosimilar of NEULASTA, Amgen has asserted that Mylan infringes two protein purification process patents: U.S. Patent Nos. 8,273,707 and 9,643,997. Early this month, the district court requested the parties’ positions with regard to the ’707…

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Mylan and Upjohn to Join Forces

Mylan N.V. and Pfizer Inc. recently announced that Mylan and Upjohn, Pfizer’s off-patent branded and generic business, will combine to form a new company.  According to the press release, each Mylan share would be converted into one share of the new company.  Pfizer shareholders will own 57% of the combined new company,…

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Amgen, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October.  On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets.  This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall.  According to…

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Mylan Files Ten Additional IPR Petitions Challenging Sanofi's Lantus Patents

As we reported here, on June 9, 2017, Mylan filed two IPR petitions challenging Sanofi-Aventis’s U.S. Patent No. 7,476,652 (IPR2017-01528) and U.S. Patent No. 7,713,930 (IPR2017-01526), related to Sanofi’s Lantus® (insulin glargine injection).  Both petitions were instituted on December 13, 2017, as reported here. On September 10, 2018, Mylan filed ten additional…

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DEAL WATCH: Lupin and Mylan Announce Partnership to Commercialize Etanercept Biosimilar

Lupin Ltd. and Mylan N.V. both issued press releases today announcing a collaboration to commercialize a biosimilar to Amgen’s Enbrel® (etanercept).  Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia. According to the press releases, Lupin successfully completed its…

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