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Top US Generics Players Thwarted On August At-Risk Launch Of Fingolimod

 
• By Aidan Fry

Difficulties around damages, fears over first-dose observations and criticism of invalidity challenges all contributed to a US district court judge issuing a preliminary injunction to stop leading generics players launching rivals to Novartis’ Gilenya fingolimod multiple sclerosis brand after the molecule patent expires in August this year.

Injunction
Leading US generics players have been hit by an injunction preventing launch of fingolimod pending trial over a dosage regimen patent • Source: Shutterstock

The prospect of “massive and immediate price erosion in the market for oral treatment of relapsing-remitting multiple sclerosis” if up to six generic fingolimods were launched at-risk in the US when a molecule patent protecting Novartis’ Gilenya expires in mid-August this year has persuaded a Delaware district judge to grant an preliminary injunction barring generic competition until a decision at trial.

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Sandoz Admits To Widescale Infringement In Resolving US Rinvoq Patent Tussle

 
• By Dean Rudge

Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.

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

 
• By Dave Wallace

After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?

Sandoz Attacks Amgen Over US Enbrel Exclusivity

 
• By Dave Wallace

Having failed in US patent litigation over Amgen’s Enbrel, Sandoz is taking an alternative approach in trying to get its Erelzi biosimilar to market in the US ahead of patent expiry in 2029: launching an antitrust attack against the originator for “unlawfully extending and entrenching its monopoly."

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.

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Xbrane Approves Deal Giving Away Cimzia Rival To Alvotech

 
• By Adam Zamecnik

After announcing the agreement last month, Xbrane has now approved its deal with Alvotech as part of an extra general meeting.

Celltrion Celebrates Interchangeability Designation For Humira Biosimilar In The US

 
• By Urtė Fultinavičiūtė

Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.

Samsung Bioepis Reevaluating Approach To Biosimilars

 
• By Jessica Merrill

The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.