Strategy
Reformulation specialist Lipella has an eye on numerous milestones for its proposed oral rinse liposomal formulation of tacrolimus, including the submission of a Phase IIb clinical trial investigational new drug application.
Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.
In an update to its strategy for dealing with US tariffs, Korea’s Celltrion has revealed actions taken so far, as well as outlining plans to consider moving “swiftly” to secure US manufacturing for APIs if circumstances demand.
A journey began eight years ago continues for Doc Generici – now rebranded as DOC Pharma – as it continues to diversify its offerings beyond conventional generic prescription pharmaceuticals.
Cosette Pharmaceuticals has made two key executive appointments as it looks to build up its business. Meanwhile, Canada’s CGPA has named a chair and vice-chair, and Chanelle and Neuraxpharm have announced their own executive changes.
Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.
Samsung Bioepis is only the second firm to receive a US FDA endorsement for its denosumab biosimilars, with the nod coming at the same time as formal European Commission approval. But plenty more firms are waiting in line with their own rivals to Prolia and Xgeva.
Sanofi has bolstered its insulin offerings by bagging the first US FDA approval for a rapid-acting insulin aspart biosimilar, leaving several would-be sponsors in its wake.
A US tariff on imports from China raises the spectre of similar action against India, but Aurobindo, the largest generics company in the US by prescriptions dispensed, assures it has alternatives in place. While trials for an opthalmology biosimilar are delayed, supply of other biosimilars to Europe is set to begin in Q2 FY26.
Canada’s largest generics manufacturer Apotex will look to expand its channels to include health food stores, new professional channels including naturopathic doctors, and grocery retail channels, after acquiring Ontario-based natural health firm CanPrev for an undisclosed sum.
India’s Gland Pharma had much to discuss during its financial third-quarter earnings call, including a recent CDMO partnership with China’s Shanghai Henlius Biotech that could lead to the establishment of further manufacturing space to meet demand.
Bio-Thera Solutions has taken the next step towards launching competition to Johnson & Johnon’s Simponi blockbuster, filing its Stada-partnered BAT2506 golimumab candidate with Europe’s regulatory body following successful Phase III comparison data.
Slovenian firm Krka addressed concerns about potential capacity restrictions during its recent preliminary annual earnings call, stating that it was continuing to work with partners while maintaining its own investments to meet its goals.
Celltrion may consider establishing or acquiring US manufacturing facilities as well as securing more US inventory and shifting its focus onto drug substance rather than drug product imports, the Korean biosimilars giant has suggested, as it sought to assuage investor concerns over pharmaceutical tariffs announced by US president Donald Trump.
In the aftermath of last week’s J.P. Morgan Healthcare Conference in San Francisco, Generics Bulletin’s editorial team brings you additional coverage of items of interest for the global generics and biosimilars industry.
In its presentation at this year’s J.P. Morgan Healthcare Conference, Hikma highlighted its efforts in all three of its businesses, with optimism across the board.
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.
At the J.P. Morgan Healthcare Conference in San Francisco, Sandoz CEO Richard Saynor commented on the “offensively” low pricing for antibiotics in the US – “less than a packet of M&Ms” – while also revealing that the firm has struck a deal with a US PBM for its Samsung Bioepis-partnered Pyzchiva ustekinumab biosimilar to Stelara.
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.
Viatris expressed confidence at the J.P. Morgan Healthcare Conference that it will hit its targets for complex injectables in 2025, while providing an update on its GLP-1 ambitions and its delinquent manufacturing facility in Indore, India.