On June 3, Mylan N.V. and Biocon Ltd. presented phase 3 clinical data regarding their trastuzumab product (dubbed MYL-1401O), which is a proposed biosimilar to Genentech’s Herceptin, at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. Trastuzumab is indicated for the treatment of HER2-positive metastatic breast cancer patients,…
On May 16, 2016, Sorrento Therapeutics announced successful results from a Phase 2 and 3 clinical study for a biosimilar to Xolair. Xolair (omalizumab) is marketed by Genentech and Novartis to treat allergic asthma and chronic idiopathic urticaria (a chronic skin condition). Sorrento’s biosimilar product, dubbed STI-004, proved to be…
IPR2015-01624 (U.S. Patent No. 6,331,415) (Sanofi-Aventis and Regeneron) (Cabilly patent) – Institution of IPR The PTAB has instituted IPR on U.S. Patent No. 6,331,415.
IPR2016-00383 (Genzyme Corp.) (U.S. Patent No. 6,331,415) Petitioner: Genzyme Corp. Patent: U.S. Patent No. 6,331,415 Patent Title: Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein Patent Owner: Genentech, Inc. and City of Hope
In a decision that could have implications for biosimilar drug manufacturers whose products are used for off-label uses, on October 30, 2015, Texas judge Michael Mery threw out strict liability, implied warranty, and negligence claims brought by plaintiff Robert Burt against Genentech Inc. and Genetech USA, Inc. The complaint alleged…
As we reported in an earlier post, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants. Since then, several entities have submitted comments regarding AbbVie’s petition—some in support and others adamantly opposing—and AbbVie has supplemented its original petition. We’ve summarized those submissions in…
IPR2015-01624 (Sanofi-aventis and Regeneron) (U S Patent No 6,331,415) Petitioners: Sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. Patent: U.S. Patent No. 6,331,415 Patent Title: Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein
On June 24, 2015, the UK’s High Court of Justice Patents Court invalidated a Genentech patent (EP 1037926 (“the ’926 patent”)) for the combined use of Herceptin (trastuzumab) in combination with the chemotherapeutic taxane for treatment of HER2-positive breast cancer. Hospira brought this action as part of a series of patent…