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,…
A recent court ruling and a new publication on guidelines for biosimilars in India may offer further guidance on what biosimilar and biologic stakeholders can expect from Indian regulatory authorities. In late March, India’s Central Drugs Standard Control Organization (CDSCO) published Proposed Revised Guidelines on Similar Biologics (2016), offering guidance…
This is an update on the latest activity before the United States Supreme Court in the ongoing dispute between Amgen and Sandoz regarding Sandoz’s biosimilar application for Zarxio® (filgrastim-sndz). Federal Circuit Proceedings As we previously reported, in May last year, a split Federal Circuit panel held that the patent dance…
Biocon, a prominent Indian biopharma company, entered into a partnership with Mylan in 2009 for joint research and development of biosimilars. That partnership now appears to be yielding results. The companies expect to submit regulatory filings in both the U.S. and EU 2016: trastuzumab, pegfilgrastim, adalimumab, and insulin glargine. As Big…
On January 8, 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an exclusive global collaboration agreement to jointly develop, manufacture, and commercialize six of Momenta’s current biosimilar medications. According to public information about the agreement, while each company will equally share costs and profits with respect to the products,…
Yesterday Mylan, and Hospira and Celltrion (jointly) filed amicus briefs in support of Apotex’s appeal to the Federal Circuit in Amgen v. Apotex. They joined the Biosimilars Council, which filed its amicus brief Wednesday. Further analysis to come.
Hospira, Inc., Celltrion Healthcare Co., Ltd., and Celltrion Inc. (jointly) and the Biosimilars Council filed amicus briefs today in support of Sandoz’s petition for rehearing en banc in Amgen v. Sandoz. The briefs are now publicly available and are attached here and here. UPDATE: Mylan Inc. has also filed an amicus…