Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2016: 5. Various guidance documents have been published this year further defining regulatory requirements for biosimilars. The World Health Organization (WHO) proposed a naming convention for biological active substances. Specifically, the WHO…
Yesterday, Coherus filed its Petitioner Reply in IPR2016-00188 (U.S. Patent 9.017,680), IPR2016-00189 (9,073,987), and IPR2016-00172 (U.S. Patent 8,889,135). Each of these patents is owned by Abbvie, and, according to the documents filed in these IPRs, each relates to Humira® (adalimumab). We have added these Replies to our IPR Tracker Page,…
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®…
The FDA issued a new Guidance today, titled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” The Guidance is intended to “assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its…
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,…
Earlier this week, Hungarian pharmaceutical maker Gedeon Richter Plc. announced that is has withdrawn its Marketing Authorization Application for its pegfilgrastim biosimilar from the European Medicines Agency. According to the announcement, the Committee for Medicinal Products for Human Use (CHMP) expressed that “the data provided did not allow the Committee…
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…
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…
This morning, in the district court action in Janssen v. Celltrion, Judge Wolf issued an oral order denying the defendants’ motion for partial summary judgment of non-infringement of U.S. Patent No. 7,598,083 (“the ’083 patent”) as it relates to Celltrion, but ordered further briefing to the extent the motion concerns…
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…