Early last month, we reported that in the Amgen v. Hospira BPCIA litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, Hospira had filed an appeal to the Federal Circuit from the Delaware district court’s final judgment of infringement and validity of one of the patents-in-suit, U.S. Patent No. 5,856,298, and the…
As we reported, last month in the Amgen v. Hospira litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, the Delaware district court entered final judgment against Hospira, awarding Amgen $70 million in damages and approximately $10 million in pre-judgment interest, plus post-judgment interest in an amount to be determined at a…
On September 12, 2018, Boehringer Ingelheim announced positive results from a Phase III clinical trial for its approved adalimumab biosimilar, Cyltezo®. The clinical trial compared the efficacy, safety and immunogenicity of Cyltezo® and Humira® in patients with moderate-to-severe chronic plaque psoriasis. According to Boehringer Ingelheim, the study confirmed equivalence of Cyltezo®…
On August 6, 2018, STADA Arzneimittel AG (“STADA”) announced that it had acquired a majority stake in BIOCEUTICALS Arzneimittel AG (“BIOCEUTICALS”). According to the press release, STADA is acquiring an additional 35.48 percent of the shares in BIOCEUTICALS from its co-shareholders to bring its total stake to 51.34 percent. BIOCEUTICALS…
Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of non-infringement in favor of Sandoz in the Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen filed…
Goodwin attorneys and Big Molecule Watch editors Keith Zullow, Michael Cottler, and Joshua Whitehill were recently published on Bloomberg Law. Disputes often arise regarding what is required of a biosimilar applicant to comply with Subsection (l)(2)(A) of the BPCIA, a provision that kicks off the patent dance. Although this issue…
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in favor of the biosimilar applicants. The other five appeals are from final written decisions of the…
According to an announcement by Samsung Bioepis, an additional one-year follow-up study on SB3, a biosimilar candidate referencing Herceptin® (trastuzumab), showed low incidence of cardiac safety events and no statistically significant difference in survival results compared to trastuzumab in patients with HER2-positive early or locally advanced breast cancer. The data…
As we reported earlier this month, Coherus BioSciences recently resubmitted its application for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim), in response to a Complete Response Letter that it received from the FDA last June. Yesterday, Coherus announced that the FDA has accepted its pegfilgrastim resubmission and that the FDA considered…
Last June, we reported that Coherus BioSciences had received a Complete Response Letter (CRL) from the FDA for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim). Later, in August, we reported that Coherus had anticipated resubmitting its BLA in response to the CRL. Today, Coherus announced that it has resubmitted its BLA…