Amgen announced today the launch of AMJEVITA (adalimumab-atto), a biosimilar to AbbVie’s HUMIRA (adalimumab), in the United States. AMJEVITA was the first HUMIRA biosimilar approved by the FDA and is now the first to be launched in the United States. AMJEVITA is approved to treat seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis in adults,…
As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at the Federal Circuit, and at the PTAB. Below is our recap of…
On November 29, 2022, Janssen filed a BPCIA complaint in the District of Delaware against Amgen related to Amgen’s ustekinumb biosimilar ABP 654 of Janssen’s STELARA. This is Janssen’s first BPCIA case filed with respect to an ustekinumab biosimilar. Janssen alleges that its “scientists and clinicians spent decades developing STELARA…
The U.S. Supreme Court agreed today to review “whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the…
On October 12, 2022, Amgen released its 2022 Biosimilar Trends Report. Since we posted on Amgen’s report preview in July, the total number of biosimilars that have been approved in the United States has increased from 36 to 39 (with the approval of Coherus’s CIMERLI (ranibizumab-eqrn) in August and Fresenius…
On August 23, 2022, Amgen announced positive top-line results from a phase 3 study of ABP 959, Amgen’s proposed biosimilar to SOLIRIS (eculizumab). Amgen noted that the study was “a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to…
The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars. Here we report on the results of two recently completed studies. On June 30, 2022, a study was published showing that the efficacy of AryoGen Pharmed’s biosimilar denosumab candidate, ARYLIA, is noninferior to Amgen’s PROLIA for the…
On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen’s RIABNI (rituximab-arrx), a biosimilar to Genentech’s RITUXAN®, in combination with methotrexate for treatment of moderate to severely active rheumatoid arthritis (RA). RIABNI has been approved since December 2020 for treatment of adult patients with…
Amgen recently announced preliminary results from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA (ustekinumab) in adult patients with moderate to severe plaque psoriasis. According to Amgen, the “study met the primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and…
In 2021, the FDA’s Purple Book went live, providing a searchable database of licensed biological products, including the patent information provided to biosimilar applicants during the patent dance. Pursuant to a law enacted in late 2020, a reference product sponsor must now provide patent information to FDA for listing in the Purple Book…