Tagged as: Amgen

Amneal, Amgen, and Kashiv jointly stipulate to dismiss patent in filgrastim litigation

As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a protein refolding process. In their answer, Adello sought a declaratory judgment that certain claims of the ’138 patent were not infringed…

Read More

Accord BioPharma substituted for Apotex as party in filgrastim/pegfilgrastim biosimilar litigation

As we previously reported, the parties in the follow-on Amgen v. Apotex BPCIA litigation concerning Apotex’s proposed biosimilars of NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) informed the district court on August 8 that they were drafting a stipulation and unopposed motion that would substitute Apotex as a party with a then-unnamed…

Read More

Amgen and Allergan Announce Positive Results from Clinical Study of Rituxan Biosimilar Candidate

On August 22, Amgen and Allergan announced positive top-line results from a clinical study (JASMINE) comparing the efficacy and safety of the biosimilar candidate ABP 798 (rituximab) to the reference drug Rituxan® in patients with CD20-positive B-cell non-Hodgkins lymphoma. As we reported in January, ABP 798 was previously found to…

Read More

Federal Circuit Will Not Halt Sales of Amgen’s MVASI (bevacizumab-awws) Before It Resolves Genentech’s Appeal

As we previously reported, after Amgen obtained FDA-approval for MVASI (bevacizumab-awws), a biosimilar of Genentech’s AVASTIN, Amgen submitted—and the FDA approved—a number of supplements that revised, among other things, manufacturing and labeling information for the product. Genentech subsequently filed a motion in the district court, arguing that the FDA’s approval…

Read More

Amgen Drops Assertion of One Patent Against Mylan in Pegfilgrastim Biosimilar Litigation; One Patent Remains

As we previously reported, in the Amgen v. Mylan litigation concerning Mylan’s FULPHILA (pegfilgrastim-jmdb), a biosimilar of NEULASTA, Amgen has asserted that Mylan infringes two protein purification process patents: U.S. Patent Nos. 8,273,707 and 9,643,997. Early this month, the district court requested the parties’ positions with regard to the ’707…

Read More

Federal Circuit Declines to Block Sales of Amgen’s KANJINTI (trastuzumab-anns) Before Resolving Genentech’s Appeal

As we previously reported, Genentech has appealed the Delaware district court’s denial of its preliminary injunction motion that sought to bar sales of Amgen’s KANJINTI (trastuzumab-anns) biosimilar in the United States.  In conjunction with its appeal, Genentech also asked the Federal Circuit (1) to issue an injunction against Amgen pending…

Read More

BREAKING NEWS: Federal Circuit Affirms Coherus Victory Over Amgen in Pegfilgrastim Patent Dispute

As we previously reported, last year Amgen appealed a Delaware district court’s decision dismissing Amgen’s patent infringement complaint under the BPCIA against Coherus on the ground that Coherus’s biosimilar of NEULASTA (pegfilgrastim) could not be found to infringe Amgen’s patent under the doctrine of equivalents (Amgen’s only asserted basis for…

Read More