Following up on our prior reports, last week President Trump signed into law the “Patient Right to Know Drug Prices Act” (S.2554). Among other changes, the bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require that Reference Product Sponsors and biosimilar applicants file patent settlement agreements…
Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. According to Amgen, two Phase 3 studies confirmed that AMGEVITA showed biosimilarity to adalimumab, showing no clinically meaningful…
Below are some recent announcements from Momenta Pharmaceuticals, Fresenius Kabi, JHL Biotech, and Innovent Biologics regarding their biosimilar pipelines. On October 1, 2018, Momenta Pharmaceuticals announced that it completed a strategic review of its pipeline with the goal of reducing costs of biosimilar development and focusing its resources on its…
On October 11, 2018, AbbVie and Sandoz announced that they reached a global resolution of all intellectual property-related litigation concerning Sandoz’s Hyrimoz™, a proposed biosimilar of Humira® (adalimumab). According to the press releases, under the terms of the royalty-bearing settlement agreements, AbbVie is granting to Sandoz a non-exclusive license to…
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…
As reported here, the Oncologic Drug Advisory Committee (ODAC) held a public hearing today at the U.S. Food & Drug Administration to discuss and vote on Celltrion’s Biologics License Application for CT-P10, a proposed biosimilar of Genentech’s U.S.-licensed rituximab product Rituxan. The hearing included presentations from various speakers from industry,…
Below are some recent updates regarding U.S. regulatory submissions and a launch in connection with biosimilar products: On September 27, 2018, Samsung Bioepis announced that the U.S. FDA has accepted its aBLA for SB5, a proposed biosimilar of Humira® (adalimumab), which Bioepis submitted to the FDA in July. According to…
Today, the PTO announced that it has published a final rule changing the claim construction standard applied during IPR, PGR, and CBM proceedings before the PTAB. The final rule replaces the “broadest reasonable interpretation” standard with the claim construction standard that is used to construe claims in civil actions in…
We have covered Pfizer’s development of biosimilars of Genentech’s Avastin® (bevacizumab) and Herceptin® (trastuzumab) and its related IPR filings IPR2016-01771 and IPR2016-01837. Following written decisions invalidating those two patents, Genentech appealed and challenged the constitutionality of subjecting patents that issued before the America Invents Act (AIA) was enacted in 2011…
On October 1, the Trump administration announced that it had secured a new trade agreement with Canada and Mexico. The United States-Mexico-Canada Agreement (USMCA) would replace the North American Free Trade Agreement (NAFTA), which has been in place since 1994. According to the White House press release, “[t]he new agreement includes…