Biosimilars

Chinese biosimilars developer Henlius has celebrated its first shipment to the US, opening up a potentially lucrative market for the firm via local marketing partner Accord.

Coherus is fully exiting the biosimilars space after striking a final deal worth up to $558m to divest its Udenyca US pegfilgrastim franchise to Accord parent company Intas.

The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.

Biocon has become the latest ustekinumab biosimilar developer to garner approval from the US Food and Drug Administration – and the Indian giant already has a settlement in place that will allow it to be among the first to launch in 2025.

Alvotech will consider its options upon the potential US approval of its proposed biosimilar to Eylea, though the firm maintains that its formulation has been developed with the patent landscape in mind.

Unlike the market-leading Ocrevus, biosimilar competition to Novartis’ Kesimpta blockbuster for multiple sclerosis hasn’t begun to materialize just yet, according to the Swiss originator.

When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.

Regeneron has taken a further swipe at Amgen after the biosimilars sponsor surprised the market by launching the first US rival to Eylea at-risk last month.

Having previously set itself a deadline of the end of November to strike a licensing deal for one of two biosimilar candidates – or risk failing to meet its working capital requirements – Sweden’s Xbrane has now announced a global licensing partnership with Intas for its nivolumab Opdivo rival, with just days to spare.

The latest campaign from Biosimilars Canada, #SaveBigWithBiosimilars, targets businesses to raise awareness of the benefits of using biosimilars for employee health benefit plans.

Dual filings for Formycon’s aflibercept biosimilar have delivered results, with the Eylea rival endorsed under two names by the EMA’s CHMP.

Samsung Bioepis may be only the second company to obtain an EMA positive opinion for a denosumab biosimilar, but plenty more rivals are on the way with filings of their own.

As Fresenius delivered its third-quarter results, the firm’s Fresenius Kabi division celebrated sales growth of two-thirds in its Biopharma biosimilars segment amid several solid increases seen in Q3.

Fresenius Kabi-controlled mAbxience has struck a deal with Servier’s Egis Pharmaceutical to commercialize two biosimilar candidates in multiple central and eastern European markets.

Running from 11-14 November, the fifth annual Global Biosimilars Week awareness campaign has been launched by the IGBA, with the international off-patent association this year focusing on advancing access.

Meitheal has announced a licensing agreement with parent company Hong Kong King-Friend to add another three biosimilars to its pipeline for the US market.

Coherus BioSciences will have to weather the storm of supply interruptions for its sole biosimilar product, Udenyca, in the final quarter of 2024.

In the first earnings call since Amgen confirmed launch of the first US biosimilar to Regeneron’s near $6bn Eylea brand, the originator spoke of its confidence in defending its brand, while also touching on how supply issues for repackaged Avastin had impacted its operations.

Alvotech and Advanz have celebrated a worldwide first with the European Medicines Agency’s acceptance of an application for their partnered golimumab biosimilar rival to Simponi.

All eyes are on Eylea, after Amgen said last week that it would launch the first US biosimilar in the face of ongoing litigation. The California-based player has spoken of its prospects in the wet-AMD space, including a desire to chart its own path amid supply shortages for Avastin.