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Coherus Refiles US On-Body Pegfilgrastim, With Potential For 2023 Approval

Company Indicates That Quick Resolution Of CRL Could Lead To FDA Nod By Year End

 
• By Dean Rudge

Coherus BioSciences has swiftly returned a filing for its on-body pegfilgrastim biosimilar candidate to the US Food and Drug Administration, while hitting a milestone for its Cimerli biosimilar to Lucentis (ranibizumab).

Target
• Source: Shutterstock

Coherus BioSciences has resubmitted to the US Food and Drug Administration its filing for the company’s version of Amgen’s Neulasta (pegfilgrastim) Onpro on-body injector device using Coherus’ Udenyca (pegfilgrastim-cbqv) biosimilar, weeks after an FDA complete response letter stopped the firm in its tracks.

The California-based firm has reiterated that it is “committed to working closely with the FDA,” anticipating

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Amgen Locked Out Of Canadian Eculizumab Market Until 2027

 
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Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
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‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By Dave Wallace

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

Biocon Biologics Plans To Slow Down After Five Planned Near-Term Biosimilar Launches

 
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With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.

Biocon Eyes Fundraising Round Amid Discussions On Merger With Biosimilars Branch

 
• By Urtė Fultinavičiūtė

As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.