By mid-February next year, Pfizer plans to have introduced in the US bevacizumab, rituximab and trastuzumab biosimilars to Avastin, Rituxan and Herceptin.
Pfizer plans to follow up its US introduction of its Zirabev (bevacizumab-bvzr) biosimilar at the end of this year by launching its Ruxience (rituximab-pvvr) biosimilar to Roche’s Rituxan in January 2020, followed on 15 February next year by rolling out its Trazimera (trastuzumab-qyyp) treatment for various cancers.
Trazimera’s market entry will come almost a year after Pfizer in March 2019 secured approval from the US Food and...
Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.
Samsung Bioepis has announced a fresh ophthalmic biosimilars partnership with Harrow, as the end approaches for a longstanding US commercialization alliance with Biogen on the Korean firm's Lucentis (ranibizumab) and Eylea (aflibercept) rivals Byooviz and Opuviz.
As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.
After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.
The Medicines Patent Pool’s extended voluntary license to produce long-acting cabotegravir to treat HIV is a win for patients living in LMICs, as the WHO updated its guidance to recommend it as an alternative treatment option.
Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.
After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.
