Category: patent litigation

Preparations Being Made for Much-Delayed Introduction of Enbrel Biosimilars

Samsung Bioepis and Teva announced a deal in which Teva will commercialize Samsung’s etanercept biosimilar Eticovo; launch date should be in 2028.

Samsung Bioepis’ deepening ties with Teva has yielded a new deal for its etanercept biosimilar Eticovo. Under the new agreement, Teva will obtain US commercialization rights to Eticovo. The timing of Eticovo’s commercial launch in the US will be determined by Teva, according to the press release.

The Long Delay to Etanercept Biosimilar Launch Nearing the End

Even though two etanercept biosimilars were approved by the FDA in 2016 and 2019, respectively, judicial interpretations of the reference product’s patent expirations have kept the biosimilars off the US market for more than a decade relative to its EU launch. Without the ability to commercialize the biosimilar until at least 2028, other biosimilar manufacturers have avoided further development. At an annual net sales revenue of around $3 billion, Enbrel’s manufacturer (Amgen) has reaped at least $30 billion in additional sales since the first etanercept biosimilar approval.

etanercept biosimilars

Sandoz has not yet disclosed commercialization plans for its etanercept biosimilar Erlezi, but it has been very active on both the manufacturing phase and as a marketing partner. As there still only two etanercept biosimilars approved in the US, there may still be significant sales opportunities for these products.

As part of the new agreement, Teva will also obtain US commercialization rights to Samsung Bioepis’ infliximab biosimilar Renflexis in the third quarter of 2027. Organon and its predecessor Merck had possessed the rights to this biosimilar product since its launch in 2017.

According to the agreement, “Teva will pay Samsung Bioepis an upfront payment over the next 3 years. Samsung Bioepis may be eligible for additional launch and sales milestones payments. Teva and Samsung Bioepis will share profit from the commercialization of these products.”

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA. 

Biosimilar Bytes: Golimumab Patent Litigation, Positive Keytruda Biosimilar Trial Results

Janssen files BPCIA patent suit against an impending Alvotech golimumab biosimilar, and Samsung Bioepis releases positive phase 3 trial results

Golimumab Patent Battle for Alvotech and Bio-Thera Biosimilars

Alleging patent infringement, Janssen Biotech filed BPCIA litigation in US District Court for the Eastern District of Virginia against Alvotech involving AVT05, its golimumab biosimilar candidates. According to Janssen, 14 patents each are at issue on its reference products Simponi and Simponi Aria.

Janssen BIotech v Alvotech patent litigation

Alvotech and its commercialization partner Teva resubmitted its 351(k) application for approval of ATV05 on June 4. It is not known why Janssen did not file the BPCIA patent suit once Alvotech first sent its biologic licensing application to the FDA in January 2025.

Bio-Thera Solutions and its marketing partner Accord BioPharm received the first FDA approval for golimumab biosimilars on May 15, 2026. Of course, they are also in the midst of patent litigation with Janssen to prevent a delay in marketing of this biosimilar as well. Janssen first filed its complaint in March 2026, involving 17 patents. In response, Bio-Thera filed for Inter Partes Review on 4 patents involving methods of treatment, while claiming the others were either obvious or publicly available. According to Big Molecule Watch, a District Court hearing is scheduled for September 1. The principal patents on Simponi have already expired. Accord BioPharm had previously announced an expected launch later this year.

Samsung Bioepis’ SB27 Phase 3 Results

Despite several other prospective pembrolizumab biosimilar makers foregoing or discontinuing phase 3 trials, Samsung Bioepis has plowed forward, announcing preliminary positive results for its investigational product SB27.

Although the phase 1 and phase 3 trials are not yet completed, the initial results announced indicated equivalent pharmacokinetic data for SB27 compared with the reference product Keytruda, as well as clinically similar outcomes (i.e., objective response rates) in the double-blind, parallel-group, phase 3 investigation at week 24.

The FDA announced last October that late-stage clinical trials will no longer be routinely required for biosimilar development and approval. Most manufacturers pulled the plug on ongoing or planned trials for pembrolizumab biosimilars, as we reported in November.

Samsung reported that it expects to complete both the phase 1 and phase 3 trials by the end of 2026.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated biosimilar approval database.