Pfizer announced today that PF-06410293, its proposed biosimilar to Humira® (adalimumab), has demonstrated equivalent efficacy to Humira® in a clinical study. The clinical study gathered data from a 12 week trial in which patients with rheumatoid arthritis were randomized to receive either Humira® or the proposed biosimilar, both in combination with…
On January 3, 2017 in the Amgen v. Sanofi/Regeneron action, Judge Robinson denied Defendants’ motion for judgment in their favor as a matter of law (JMOL) and request for a new trial regarding written description and enablement of the asserted claims of the patents-in-suit. On March 16, 2016, after a trial,…
Yesterday, in the Janssen v. Celltrion action, Janssen filed a supplemental brief on the issue of whether Hospira may be liable for infringement on the theories of joint enterprise, agency, or contract. As we previously reported, the Court ordered the parties to brief this issue after it arose during oral arguments on the motions for…
Merck Sharp & Dohme filed two petitions for inter partes review of Genentech’s U.S. Patent 6,331,415, one of the “Cabilly Patent,” which claims processes and materials broadly applicable to recombinant antibody manufacturing. Today, the PTAB granted one of those and denied the other. IPR2017-00047 was filed along with a motion…
After another milestone year, here are our picks for the top-five biggest deals in the world of biosimilars in 2016: 1) As we reported in January 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an exclusive agreement to jointly develop, manufacture, and commercialize six of Momenta’s current biosimilar medications,…
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,…