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Year in Review: the Top-five U.s. Market Developments of 2016

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a biosimilar version of Amgen’s Neupogen® (filgrastim).  The first 2016 approval was Celltrion and Pfizer’s Inflectra®…

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Year in Review: The Top-Five Legal Developments of 2016

Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016: 5) Congress passed and President Obama signed the 21st Century Cures Act.  Among other things, the Act modifies the standards and review processes for FDA evaluation of applications to market new drugs,…

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Amgen Files Supplemental Brief in sandoz V. Amgen

On Tuesday, Amgen filed its supplemental brief opposing Sandoz’s petition for writ and responding to the Solicitor General’s brief, which we discussed here. In sum, the Solicitor General sided with Sandoz, stating that: notice of commercial marketing before FDA approval is consistent with § 262(l)(8)(A); injunctive relief is not available…

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PTAB Upholds Validity of BMS Patent

The PTAB issued a Final Written Decision upholding the validity of Bristol-Myers Squibb’s U.S. Patent 8,476,239, which had been challenged by Momenta in IPR2015-01537.  According to documents filed with the PTAB during the IPR, the ‘239 patent covers stable formulations of a protein called “CTLA4Ig.”  This protein is sold by BMS under…

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BioCND to Develop Lucentis® Biosimilar

BioCND, a South Korean biopharmaceutical company, announced on Monday that it will begin clinical development in Korea of ranibizumab, a biosimilar of Genentech’s Lucentis® injection for patients with wet age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME). Globally, other companies have already…

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IPR Tracker: Genentech Files Preliminary Responses in IPR2016-01693 and IPR2016-01694

On December 16, 2016, Genentech filed preliminary responses in IPR2016-01693 and IPR2016-01694.  Mylan filed both IPR petitions in August against patent 6,407,213, which covers humanized antibody polypeptides and methods for their preparation and use.  The patent does not focus on any particular therapy, but Genentech notes that the approach was used to develop Herceptin®,…

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EMA Committee Recommends Approval for Celltrion’s Truxima (rituximab) Biosimilar

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to Celltrion’s Truxima (rituximab), a biosimilar to Roche’s Mabtherba, which is indicated for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. Truxima marks just the second recommended…

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