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Taking Biosimilars ‘To The Next Level’

IGBA Wants Discussion To Advance On A More Tailored Development Program

 
• By Dave Wallace

The IGBA wants to take discussions around streamlining biosimilar development to “the next level”, the association tells Generics Bulletin.

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The IGBA wants to take discussions on streamlining biosimilar development to the next level • Source: Shutterstock

Biosimilar development pathways are currently a hot topic in the off-patent industry. Established global processes for developing and registering biosimilar drugs are coming under fresh scrutiny as industry stakeholders reassess the need for certain data typically submitted to regulators as part of a biosimilar sponsor’s application.

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Biocon Chooses To Settle Over Eylea In US – Will Others Follow?

 
• By Dave Wallace

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• By Dave Wallace

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Sandoz Attacks Amgen Over US Enbrel Exclusivity

 
• By Dave Wallace

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Biocon Celebrates Long-Awaited FDA Approval For Bevacizumab Biosimilar

 
• By Urtė Fultinavičiūtė

After having its facility cleared by the FDA earlier in the year, Biocon Biologics finally saw its bevacizumab biosimilar receiving approval in the US.

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Biocon Celebrates Long-Awaited FDA Approval For Bevacizumab Biosimilar

 
• By Urtė Fultinavičiūtė

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US Bill Recap: Senate Judiciary Committee Offers Fresh Start For Reintroduced Off-Patent Drug Bills

 
• By Urtė Fultinavičiūtė

The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.

Jazz Agrees To Fork Out $145m To Resolve Most Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Jazz has agreed a nine figure settlement agreement in the US with purchasers of its Xyrem blockbuster following claims that it illegally delayed generic competition to the blockbuster treatment for narcolepsy via patent-litigation settlement agreements with several ANDA sponsors.