Policy & 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.


Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
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As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

 
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At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.

Water Pressure: How European Industry Is Pushing Back On The UWWTD

 
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Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.

Pertuzumab Leader Henlius Receives EU Accreditation For Production Lines

 
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Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.


Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’

 

Collating data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?

Alchem Fined Over Buscopan API Cartel

 
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After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Apotex Follows Biocon With Canadian Biosimilar Aflibercept Launch

 
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Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.

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.


FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Finds No ‘Serious Discrepancies’

 
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The FDA has concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements, and that there was no “mistake” or untrue statement in the original ANDA approvals, as it denied Vanda’s citizen petition.

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.

‘Disappointed’ Lipella Seeks Alternatives Following Nasdaq Delisting

 
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Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.

Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

 
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Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.