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Polpharma Prospers Again On Dutch Natalizumab

 
• By Aidan Fry

Polpharma has continued to clear the path to launching biosimilar natalizumab in Europe by prevailing in a Dutch case over a patent protecting Biogen’s Tysabri multiple sclerosis brand until 2023.

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Poland's Polpharma has prevailed against Biogen in a Dutch dispute over a natalizumab patent • Source: Shutterstock

Polpharma has seen its previous victory in invalidating a patent protecting Biogen’s Tysabri/Antegren (natalizumab) multiple-sclerosis brand until February 2023 upheld on appeal. The Court of Appeal in The Hague confirmed that key claims of European patent EP1,485,127 lacked either novelty or inventive step in light of prior art.

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More from Legal & IP

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By Dave Wallace

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By Dean Rudge

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

Glenmark’s UK Dapagliflozin Blocked On Appeal After Teva Readied Launch

 
• By Dean Rudge

Glenmark’s advantage for its UK generic version of AstraZeneca’s Forxiga (dapagliflozin) has quickly been snuffed out, after the originator won on appeal its request for injunctive relief.

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.

More from Generics Bulletin

Sandoz And Henlius Join Forces With $300m Ipilimumab Deal

 
• By Dave Wallace

Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.

Discounted Ustekinumab Biosimilars Further Dent J&J’s Q1 Stelara Sales

 
• By Urtė Fultinavičiūtė

With discounts reaching up to 90%, ustekinumab biosimilars have eroded originator Stelara’s sales as expected. In its latest quarterly biosimilar market report, Samsung Bioepis also analyzed the latest regulatory steps to streamline biosimilar development.

Speranza Starts Generics Offshoot In Response To Wider US Pharma Manufacturing Drive

 
• By Adam Zamecnik

Reflecting increased regulatory pressure and a wider drive towards the reshoring of pharmaceutical manufacturing to the US, Speranza has launched a new generics business called Lotus Therapeutics.