On November 8, 2016, Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). According to the Mylan press release, this submission is Mylan’s first for a biosimilar in the United States, and may lead to the first approved trastuzumab biosimilar in the United States. Mylan…
Mylan filed an amicus brief in support of Apotex’s petition for certiorari in Amgen v. Apotex. Mylan’s arguments focus on the Federal Circuit’s interpretation of the BCPIA as requiring 180 days of pre-marketing notice after licensure of a biosimilar product by the FDA. It argues that the Federal Circuit’s decisions…
Earlier this week, we reported on the amicus curiae brief filed by the Biosimilars Council in support of Apotex’s petition in Amgen v. Apotex. Mylan Pharmaceuticals Inc. has also filed an amicus brief in support of Apotex. Mylan’s brief can be found here.
On October 11, 2016, Merck Sharp & Dohme (MSD) filed for IPR on U.S. Patent No. 6,331,415, one of the Cabilly patents owned by Genentech. IPR2017-00047. MSD also filed a motion for joinder with Mylan’s petition for IPR on this patent (IPR2016-00710), representing that its petition is based on grounds…
As we previously reported, over the past year several petitions requesting Inter Partes Review (IPR) of patents that claim foundational inventions for biologic drug production were filed. Here we discuss the scope of two of the foundational patents that are currently under consideration by the Patent Trial and Appeals Board…
On September 8, 2016, the Board instituted an IPR of U.S. Patent No. 6,331,415, one of the Cabilly patents owned by Genentech. The Petitioner in IPR2016-00710 is Mylan. The ’415 patent was the subject of two other IPRS that were terminated last week following settlements between Genentech and those Petitioners, Sanofi-Aventis and…
Last week, Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Genentech’s Herceptin (trastuzumab). Trastuzumab is indicated in Europe to treat certain breast cancers and gastric cancers that overexpress the HER2 protein. As we reported previously, Mylan…
Yesterday, Mylan filed two petitions for inter partes review of Genentech’s U.S. Patent No. 6,407,213. According the petitions, the patent is directed to humanized antibodies, and Mylan expects that Genentech will rely on data regarding Herceptin® (trastuzumab) in its arguments regarding secondary considerations. We will continue to monitor and report…
Mylan N.V. and Biocon Ltd. recently announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim). In Europe, Neulasta is indicated for the treatment of certain side effects associated with cytotoxic chemotherapy, including neutropenia. According to the two companies,…
We previously reported on collaborations between Amgen and Allergan on oncology-related biosimilars. On July 21, Amgen and Allergan announced results of a Phase III trial for their ABP 980 product, which is being developed as a biosimilar to Genentech’s Herceptin® (trastuzumab). According to the companies’ press release, the trial confirmed…