Sawai Goes After Xarelto, Plaquenil With New Japanese Listings

 
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Sawai has teed up multiple new launches in Japan after reporting the listing of five generics across ten presentations in the country’s National Health Insurance drug price list. The new registrations come after the firm reported lukewarm first-half results amid ongoing domestic supply issues.

Indoco Targets UK Market With Clarity

 
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Indian player Indoco has struck a deal with UK distributor Clarity Pharma that will allow it to target the UK market with the launch of 20 products over the next 18 months.

US Market Opens Up For Henlius After First Shipment

 
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Chinese biosimilars developer Henlius has celebrated its first shipment to the US, opening up a potentially lucrative market for the firm via local marketing partner Accord.

Goodbye Biosimilars: Coherus Sells Udenyca To Intas For Half A Billion

 
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Coherus is fully exiting the biosimilars space after striking a final deal worth up to $558m to divest its Udenyca US pegfilgrastim franchise to Accord parent company Intas.


Outlook Holds Out Hope For Wet AMD Approval Despite Phase III Topline Miss

 

The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.

Lupin Takes A Step Closer To $1bn US Janumet Opportunity

 
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Lupin is looking to be ready on day one to challenge Merck & Co’s Janumet (metformin/sitagliptin) treatment for type 2 diabetes, after the US Food and Drug Administration tentatively waved through its ANDA product.

Biocon Becomes Latest Stelara Challenger In US

 
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Biocon has become the latest ustekinumab biosimilar developer to garner approval from the US Food and Drug Administration – and the Indian giant already has a settlement in place that will allow it to be among the first to launch in 2025.

‘We’re 40 Years Behind Them And The Gap Is Growing’ – Burt Calls For European Urgency On Value Added Medicines

 
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Europe risks “missing out on a massive opportunity” if it does not improve its efforts to recognize and take advantage of the benefits of value added medicines, according to Medicines for Europe sector chair and Pharmanovia CEO James Burt.


Viatris Says Goodbye To Another Generics Asset

 
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Viatris is shedding another of its off-patent interests, striking a deal for Safecor Health to acquire its US unit-dose packaging business.

FDA Provides Update On PSG Plans As 60 More Guidances Issued

 
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The latest update on product-specific guidances for generic development from the FDA included 60 new and newly-revised PSGs as well as an update on future guidances coming down the line in the next year.

BGMA Backs UK Call For Shortages Strategy

 
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The BGMA has lauded as “comprehensive and welcome” a report published by the Royal Pharmaceutical Society on UK shortages, just weeks after the BGMA put forward its own supply-chain policy proposals.

Mallinckrodt Underlines It Will Not Be A ‘Supermarket’ 12 Months After Bankruptcy

 
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Mallinckrodt has spoken about maintaining a steady organization, underpinned by few launches in the pain and neurodevelopmental disorders space.


Alvotech’s Eylea Biosimilar ‘Keeps In Mind’ US Patent Landscape

 
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Alvotech will consider its options upon the potential US approval of its proposed biosimilar to Eylea, though the firm maintains that its formulation has been developed with the patent landscape in mind.

Kesimpta Presents A Mammoth Opportunity But Novartis Isn’t Seeing Rivals – Yet

 
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Unlike the market-leading Ocrevus, biosimilar competition to Novartis’ Kesimpta blockbuster for multiple sclerosis hasn’t begun to materialize just yet, according to the Swiss originator.

Amneal Set To Debut US Byetta Competition – Two Decades After Market Entry

 
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The first GLP-1 agonist to receive US Food and Drug Administration approval, Byetta (exenatide), has generic competition at last, with Amneal bagging the first rival after Teva seemingly abandoned its proposed generic version.

US FDA Biosimilar Standards Likely Sealed Interchangeability Designation’s Fate

 

When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.


As Liraglutide Launches Loom, UK Braces For Potential Weight-Loss Explosion

 
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With a first wave of generic weight-loss medicines poised to hit the UK, local off-patent industry association the BGMA says market dynamics could be unlike those of a typical generic or biosimilar launch, with the current level of unmet demand unclear.

Regeneron: Amgen’s Eylea Biosimilar Looks To Have An ‘Inferior Profile’

 
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Regeneron has taken a further swipe at Amgen after the biosimilars sponsor surprised the market by launching the first US rival to Eylea at-risk last month.

BeiGene Blocks US Rival To Brukinsa Blockbuster Until 2037

 
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MSN Laboratories has struck a patent-litigation settlement deal with BeiGene that will allow it to launch its zanubrutinib generic rival to Brukinsa in the US from 2037.

Supreme Court Denies Norwich Bid For US Xifaxan Reprieve

 
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The US Supreme Court has failed to come to the aid of Norwich Pharmaceuticals in its legal battle over a generic version of Xifaxan (rifaximin) that has a patented indication carved out of its label. An earlier decision over the generic thus bars approval and launch until 2029.