The FDA announced today that the Oncologic Drugs Advisory Committee will hold a public meeting on July 13, 2017 in Silver Springs, Maryland to discuss two biosimilar applications. During the morning session, the committee will discuss Amgen’s application for a proposed biosimilar of Genentech/Roche’s AVASTIN (bevacizumab). During the afternoon session, the…
Two companies have announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications (MAA) for proposed biosimilar candidates. Fujifilm Kyowa Kirin Biologics Co., Ltd. announced that on May 18, 2017, the EMA accepted its application for FKB327, an adalimumab biosimilar candidate to AbbVie’s HUMIRA…
In another development in the ongoing dispute between Janssen against Celltrion and Hospira relating to infliximab, Janssen filed a new complaint on May 31, asserting infringement of U.S. Pat. No. 7,598,083. In prior 2015 and 2016 actions against the same defendants (later consolidated), Janssen had asserted direct and induced infringement…
As we previously posted, Amgen seeks discovery from AbbVie regarding its “patent dance” exchanges with other adalimumab biosimilar applicants under the BPCIA. Last Friday, AbbVie filed its response, arguing that the BPCIA prohibits disclosure of the information Amgen seeks, which is only marginally relevant since it covers patents not asserted…
Pfizer, Inc. has filed two petitions (IPR2017-01488 and IPR2017-01489) challenging claims of U.S. Patent No. 6,407,213 (“the’213 patent”). According to the petitions, the ’213 patent is directed to methods of making humanized antibodies. The petitions do not identify a particular product that may use the patented methods. IPR petitions challenging the…
The European Medicines Agency (EMA) and the European Commission have jointly released an informational guide on biosimilars for healthcare providers. The guide aims to inform healthcare providers about the benefits of biosimilars to their practices and patients. Professor Guido Rasi, Executive Director of the EMA, states the following in his Foreword:…
On June 12-14th, at the Intercontinental New York Times Square, industry leaders from both innovator and biosimilar companies will convene at ACI’s 8th Annual Summit on Biosimilars to discuss the future of biosimilars and formulate solutions to the complex regulatory and patent challenges ahead. Goodwin is a proud sponsor of…
Sources are reporting that Celltrion has received clearance from the China Food and Drug Administration (CFDA) to conduct clinical trials of Remsima (infliximab), a biosimilar of Janssen’s Remicade. This is the first time a non-Chinese company will begin clinical trials of a biosimilar mAb in China. Remsima is approved in the U.S….
On Friday, in the ongoing Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary injunction seeking to enjoin Hospira from launching its biosimilar “until Hospira has complied with the requirement of 42 U.S.C. § 262(l)(8)(A), which states that ‘[t]he subsection…
In the ongoing litigation between AbbVie and Amgen regarding Amgen’s proposed biosimilar for Humira® (adalimumab), Amgen is seeking discovery from AbbVie regarding its exchanges with other adalimumab biosimilar applicants under the BPCIA, commonly known as the “patent dance.” The parties were before the Court on May 9 for a discovery conference,…