We previously reported on the oral argument in Sandoz v. Amgen. Today Justice Thomas delivered the opinion for a unanimous U.S. Supreme Court in Sandoz v. Amgen. Briefly, the Supreme…
We previously reported on the oral argument in Sandoz v. Amgen. Today Justice Thomas delivered the opinion for a unanimous U.S. Supreme Court in Sandoz v. Amgen. Briefly, the Supreme…
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…
Two companies have announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications (MAA) for proposed biosimilar candidates….
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…
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…
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…
Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or…
As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s…
Cinfa Biotech, a Spanish company focusing on the development of biosimilars, announced positive results from their second clinical trial evaluating a biosimilar version of Amgen’s Neulasta…
As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed…