The following are some noteworthy news stories on the regulatory front: The FDA shared best practices for biosimilar development. The EMA okayed a combination of insulin glargine and lixisenatide for treatment of type-2 diabetes. If approved, which is usually a formality within around 60 days, the EU will be the first…
Novartis announced on Friday that the EGALITY study, analyzing the clinical safety and efficacy of Sandoz’s etanercept biosimilar, was published in the British Journal of Dermatology. The 52-week EGALITY study involved 531 adult patients with moderate to severe plaque psoriasis in both switched and continuous treatment arms. Patients who switched…
Below is our Fall 2016 update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly update (Summer 2016).
On November 21, 2016, Apotex submitted a reply brief in support of its petition for certiorari in Apotex v. Amgen. Previous coverage of Amgen’s opposition is available here. A procedural note: the case was also distributed on November 21 for consideration at the Supreme Court’s private conference on December 9. Given…
Continuing our watch on legislative developments affecting the BPCIA and TPP, President-elect Donald J. Trump has outlined his policy plans for the first 100 days in an announcement broadcast on YouTube. As part of his plan, he has instructed his transition team to develop a list of executive actions that…
On Thursday, Judge Robinson entered a scheduling order in the AbbVie v. Amgen (adalimumab) case. Among other things, the order sets a 20-day bench trial beginning November 4, 2019. The order also establishes a number of discovery and hearing deadlines that are somewhat different than those initially proposed before the…
Bloomberg BNA reported that a panel of regulators at the DIA 2016 Biosimilar Conference in Washington highlighted the differences among biosimilar regulations internationally and the ongoing changes as countries revise their biosimilar guidances. For instance, in Canada, biosimilars are regulated as new biologics as opposed to the U.S.’s abbreviated pathways…
As we have previously reported, Donald Trump’s election to the presidency and the maintenance of majorities by the Republican Party in both the U.S. Senate and House of Representatives have led to questions about the fate of the BPCIA, which passed as part of the Affordable Care Act (“ACA”), colloquially known as…
Today, Boehringer Ingelheim announced that results from a Phase I study demonstrate its bevacizumab biosimilar candidate, “BI 695502,” is bioequivalent to Avastin®. According to the announcement, BI 695502 met all the pre-defined primary and secondary endpoints in Boehringer Ingelheim’s “INVICTAN®-1″ study, with no clinically relevant differences in safety or immunogenicity found between the study’s BI…
As we previously reported, Amgen and Allergan are currently collaborating on four oncology biosimilars, including an Avastin® (bevacizumab) biosimilar, ABP 215. Yesterday, the companies announced the submission of a Biologics License Application (BLA) to FDA for ABP 215. According to the announcement, Amgen and Allergan believe theirs is the first BLA for a bevacizumab biosimilar…