Search Results for:

DEAL WATCH: End-of-Year Biosimilar Agreements

Following the string of biosimilar agreements announced in early November, a number of additional transactions were announced in early December, bringing 2019 to a roaring close with global biosimilars deals. On December 1, 2019, Luye Pharma Group announced that it acquired Shandong Boan Biological Technology Co. Ltd. (Boan), strengthening its…

Read More

Another Biosimilar Litigation Settlement: Amgen v. Tanvex (Filgrastim)

Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar candidate. The stipulation states that the parties agree “to the dismissal, without prejudice, of all remaining claims and counterclaims in…

Read More

Biosimilar Clinical Trial Updates

Below are highlights of recent developments in biosimilar clinical trials. On December 9, Celltrion presented the results from a phase 3 clinical trial that demonstrated similar safety and efficacy of its TRUXIMA biosimilar to the reference product RITUXAN (rituximab) in patients with advanced follicular lymphoma (AFL). On December 10, Samsung…

Read More

World Health Organization (“WHO”) Prequalifies Biosimilar Trastuzumab – WHO’s First Biosimilar

Today, the World Health Organization (“WHO”) prequalified Samsung Bioepis’s breast cancer biosimilar trastuzumab – WHO’s first biosimilar prequalification.  Prequalification is “a service provided by WHO to assess the quality, safety and efficacy of those products that address global public health priorities.”  The WHO noted that the global average price of…

Read More

BREAKING NEWS: Federal Circuit Affirms Amgen’s $70 Million Damages Award Against Pfizer Unit

This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against Hospira, a subsidiary of Pfizer, regarding a biosimilar of Amgen’s EPOGEN (epoetin alfa). On…

Read More