Biosimilars

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.

In a citizen petition to the FDA, Alvotech has called on the US agency to refrain from approving as interchangeable certain Stelara biosimilars that use a different cell line to its own ustekinumab product – including the Pyzchiva version set to be brought to market by Samsung Bioepis and Sandoz.

While Roche admits that an acceleration of biosimilar competition to its blockbuster IL-6 inhibitor Actemra/RoActemra is anticipated in the final three months of the year, the Swiss originator has been surprised by the lack of challenge to its franchise so far.

Sandoz has indicated that Amgen’s recently-announced at-risk US launch of a rival to Eylea doesn’t change its thinking around launch timing for its own FDA-approved aflibercept biosimilar.

Alvotech and US marketing partner Teva have celebrated a further approval for their Selarsdi ustekinumab biosimilar rival to Stelara that encompasses a new presentation as well as a label expansion to include adults with Crohn’s disease and ulcerative colitis.

Roche’s 2022-launched Vabysmo took no time at all to reach the coveted $1bn in sales, and the originator is continuing to feel optimistic about the newer-generation VEGF brand’s prospects, even as Amgen readies the launch of the first US biosimilar to Eylea.

Only a month after filing their second biosimilar application with Japanese regulators, Alvotech and Fuji have submitted a further one for an undisclosed biosimilar as part of their local partnership.