Biosimilars
While Amneal cannot wait to jump into unexplored biologics space, it wants to channel its GLP-1 power into the Metsera partnership and service big pharma, and less so on its own generics.
Hungary’s Gedeon Richter and its Japanese partner Mochida have together unveiled plans to file their proposed Actemra/RoActemra biosimilar with major regulators, after biosimilar competition to the IL-6 receptor inhibitor materialized in the US last year.
As Bob Bradway addressed the J.P. Morgan Healthcare Conference in San Francisco, the Amgen chief executive discussed the firm’s biosimilars business – including an ocrelizumab rival to Ocrevus that has just been added to its pipeline. Meanwhile, the CEO also outlined his expectations for imminent biosimilar competition to Amgen’s Prolia and Xgeva denosumab brands.
Partners Fresenius and Formycon have racked up another pair of approvals for their Otulfi ustekinumab biosimilar rival to Stelara, this time in the UK and Canada.
At the 2025 J.P. Morgan Healthcare Conference, Johnson & Johnson outlined a new competition blueprint for anti-inflammatory biosimilars, going beyond the next blockbuster Tremfya.
Biocon Biologics has announced a change in regulatory status for a manufacturing plant in Malaysia that could pave the way for a pair of long-awaited FDA biosimilar approvals, after similar positive news for an Indian site late last year.
Teva has announced two major biosimilars deals in quick succession, partnering with Samsung Bioepis on its US Epysqli eculizumab rival to Soliris and Formycon on its European Ahzantive aflibercept challenger to Eylea.
Celebrating its first birthday as a transformed and integrated company, Biocon casts a wider net for its ustekinumab biosimilar.
Alexion has been refused in its bid for injunctions to block the sale of Samsung Bioepis and Amgen’s European Soliris biosimilars, following a decision by the Court of Appeal of Europe’s Unified Patent Court.
Tanvex has seen its application for a trastuzumab biosimilar knocked back by the US Food and Drug Administration, receiving a complete response letter over the filing.
Aurobindo’s biosimilars business is continuing to gain momentum, with a UK approval for bevacizumab in hand and further European nods expected.
New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.
Xbrane is taking a third shot at filing its ranibizumab biosimilar rival to Lucentis with the US Food and Drug Administration. Will it succeed where it has previously failed to gain approval?
While Amgen had been expected to launch its Wezlana interchangeable biosimilar to Stelara from 1 January in the US, the firm has so far been quiet on details – including on the pricing strategy for its rival to the $10bn+ brand.
US biosimilar competition to Stelara is waiting in the wings from the very start of 2025. But with seven ustekinumab rivals already approved by the FDA and set to launch, how will things shake out in such a crowded market? Generics Bulletin looks at the contenders.
Chinese biosimilars developer Bio-Thera is expanding its Latin American partnership with SteinCares with the addition of a third product.
This year, regulators questioned the US interchangeability designation and the need for comparative efficacy trials, while finding ways to promote biosimilar development and accessibility. Will this momentum continue in 2025? Generics Bulletin spoke to experts from across the industry to hear their views.
The latest US challenger to Stelara now has an approval in hand, with Celltrion lining up to join the pack of ustekinumab biosimilars that will be launching next year.
Celltrion has emerged from the latest CHMP meeting at the EMA with three new biosimilars lined up for approval. At the same time, Biocon Biologics and Aurobindo’s CuraTeQ have also picked up positive opinions for biosimilars, while Neuraxpharm has won endorsements for a pair of hybrids.