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Coherus Looks To Galvanize Pegfilgrastim Biosimilar With New Formats

California-Based Firm Updates On Planned Novel Autoinjector Presentation

 
• By Dean Rudge

Coherus BioSciences spoke at length about its two marketed biosimilars, referencing Neulasta and Lucentis, during the company’s first-quarter earnings call.

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Coherus BioSciences is confident that it can begin to regain market share beginning in the back half of 2023 for its diminishing Udenyca (pegfilgrastim-cbqv) biosimilar, starting with the launch of its novel autoinjector form “later this month,” as well as its proposed biosimilar to Amgen’s Neulasta Onpro on-body injector device, for which it anticipates approval and launch later this year.

At the beginning of March, Coherus announced unexpectedly US Food and Drug Administration approval for a single-dose, prefilled autoinjector presentation for Udenyca, supported by a comprehensive analytical data

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Adalvo And Gedeon Richter Join Forces On Semaglutide

 
• By Dave Wallace

Adalvo and Gedeon Richter have announced a global co-development deal for semaglutide for obesity. Adalvo CEO Anil Okay spoke to Generics Bulletin about the alliance as well as the broader competitive landscape for GLP-1s.

Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

 
• By Dave Wallace

During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.