Generics Bulletin - News And Expert Analysis On Generics And Biosimilars since 2003

Interviews


Regulation


‘Europe Has To Make Up Its Mind’ – Medicines For Europe’s Sieger On The Path Ahead

 
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At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.

FDA Inspection Finds Leaks and Mold at Sun Pharma Halol Facility

 
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Sun Pharma is facing renewed scrutiny after a scathing US Food and Drug Administration inspection at its Halol facility in Gujarat painted a grim picture of a facility operating in disregard of basic pharmaceutical safety standards.

Regulatory Recap: FDA Starts ‘Radical Transparency’ Era After Publishing Over 200 CRLs

 

Generics Bulletin reviews global regulatory developments across the world.

Industry Welcomes Support From UK Life Sciences Plan

 
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A new life sciences strategy unveiled by the UK government has won plaudits from the off-patent industry for its inclusion of measures specifically geared towards generics and biosimilars – especially a £1bn savings target linked to biosimilar uptake.

Bio-Thera Matches Alvotech With US Golimumab Filing Acceptance

 
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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.

‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
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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.

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
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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.

Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 

Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.

Value-Added Medicines


‘Europe Has To Make Up Its Mind’ – Medicines For Europe’s Sieger On The Path Ahead

 
• By 

At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.

European Industry Calls For Support As It Juggles Multiple Challenges

 
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At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

One Month Remains To Enter GGB Awards 2025

 
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With the August 1 deadline looming for entries to the Global Generics & Biosimilars Awards 2025, contenders have just one month left to submit their achievements.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Legal & IP


US Federal Circuit Clears Path for MSN to Market Entresto Generic

 
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Novartis has failed to secure a court order to stop MSN from launching a generic Entresto, and has also seen an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Irish Ruling Gives Go-Ahead For Endo-Mallinckrodt Merger

 
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A ruling from Ireland’s High Court has cleared the way for Endo and Mallinckrodt to consummate their merger in early August.

FTC’s Latest Effort To Dispute Improper Patent Listings Barely Made A Dent

 

Trump’s FTC has carried on two legacies – trying to eliminate improper drug patent listings and making minimal impact on such efforts.

‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
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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.