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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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Mylan Partners with Fujifilm Kyowa Kirin Biologics

Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the European Medicines Agency (EMA) accepted FKB’s Marketing Authorization Application for review on May 18, 2017 and the companies expect to get a decision from EMA by the second half of this year. Under the agreement, FKB grants Mylan…

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FDA Releases Five-Year Plans for User Fee Programs

Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans “communicate the anticipated financial positions of the Biosimilar User Fee Amendments of 2017 (BsUFA II), the Generic Drug User…

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Celltrion Moves for Summary Judgment in Janssen v. Celltrion

Last week, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Judge Wolf of the U.S. District Court for the District of Massachusetts granted Defendants’ unopposed motion for leave to file a motion for summary judgment and accompanying briefing schedule.  In their summary judgment brief, filed on…

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IPR Updates Relating to Adalimumab and Rituximab

Last week, the Patent Trial and Appeal Board (“Board”) instituted inter partes review of two patents directed to methods of administering adalimumab for the treatment of psoriasis, based on petitions filed by Sandoz: IPR2017-02105 (challenging U.S. Pat. No. 9,090,689) and IPR2017-02106 (challenging U.S. Pat. No. 9,067,992). Separately, the Board issued…

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Immunex Files Reply In Support of Motion To Stay Dupixent® Patent Litigation

In the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, Immunex has filed a reply brief in support of its motion to stay the litigation pending Inter Partes Review of U.S. Patent No. 8,679,487 (“the ‘487 patent”), which Sanofi has opposed. Sanofi filed three IPR petitions on…

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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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Commissioner Gottlieb Addresses Biosimilars at Conference

At CNBC’s Healthy Returns conference last week, FDA commissioner Scott Gottlieb discussed plans to encourage competition and speed approval of biosimilars.  His comments largely tracked a statement that he made in early March.  Gottlieb again criticized arrangements between distributors, pharmacy benefit managers, and health plans, which he views as restricting market access. …

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LG Chem Tests LBEC0101, a Biosimilar to Enbrel (etanercept), in Rheumatoid Arthritis

The results of a Phase III study of LBEC0101, a biosimilar to Enbrel (etanercept) developed by Korean pharmaceutical company LG Chem, have been published.  The study evaluated the similarities between LBEC0101 and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid…

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