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Home / News / BioBlast®

EXPLORE OUR

BioBlast®

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: natalizumab

2024

January 31, 2024

Sandoz announced that it launched biosimilar natalizumab (Tyruko®) in Germany on 31 January 2024 for the treatment of adults with highly active relapsing remitting multiple sclerosis (RRMS).  Tyruko® was developed by Polpharma Biologics and is the first biosimilar to Biogen’s Tysabri® (natalizumab) to be launched in Europe.

The EC approved Sandoz’s Tyruko® in September 2023, and it was approved by the FDA in August 2023.

2023

September 26, 2023

Sandoz and Polpharma Biologics announced that the EC has approved Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®, as a single disease-modifying therapy (DMT) in adults with highly active Relapsing Remitting Multiple Sclerosis. This is the first EC approved biosimilar to Tysabri®.  Tyruko® was developed by Polpharma Biologics, and will be commercialised by Sandoz.

Tyruko® was approved by the FDA on 25 August 2023. The EU CHMP issued a positive opinionrecommending approval of Tyruko® on 21 July 2023. 

August 25, 2023

Sandoz announced that the FDA approved its biosimilar Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri, for all indications covered by Tysabri®.  It is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS).  Tyruko® was developed by Polpharma Biologics pursuant to a global commercialisation agreement with Sandoz reached in 2019.  As part of the agreement, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

This news comes just a week after Sandoz announced its spin-off from Novartis is planned for 4 October 2023.  On 21 July 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion Tyruko® to treat active relapsing remitting MS.

July 21, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for three biosimilars:

  • Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra®. Tyenne® is intended for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19. Tyenne is the first biosimilar for this active substance.
  • Sandoz’s Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®.  Tyruko® is intended to treat active relapsing remitting multiple sclerosis.
  • BGP Pharma’s Yesafili® (aflibercept), a biosimilar to Regeneron’s Eylea®. It is intended to treat age-related macular degeneration

To obtain approval in Europe, the European Commission needs to approve the above positive recommendations from the CHMP.

During this same July 2023 CHMP meeting, the CHMP also issued a positive opinion for BMS’s Opdivo® (nivolumab) to treat completely resected stage IIB or IIC melanoma and Merck’s Keytruda® (pembrolizumab) to treat HER2-Positive Advanced Gastric or Gastroesophageal Junction.

June 29, 2023

The US District Court of Delaware has denied Biogen’s motion for preliminary injunction in its proceedings against Sandoz which were commenced in September 2022 regarding Sandoz’s natalizumab biosimilar.  Biogen and Sandoz filed a joint stipulation and proposed schedule, seeking a preliminary injunction after 07 April 2023.   Biogen filed a sealed complaint against Sandoz and Polpharma in September 2022, alleging infringement of 28 Biogen patents. Oral argument was heard on 17 May 2023.  The Court held that Biogen failed to demonstrate that it would suffer irreparable harm in the absence of an injunction and that it would likely succeed on the merits.  Interestingly, the Court confirmed in a footnote of the orders that it will ‘try its best to schedule a trial before April 2025’.

April 18, 2023

The US District Court of Delaware has ordered that Biogen Inc.’s and Biogen MA, Inc.’s Motion for Preliminary Injunction against Sandoz’s biosimilar natalizumab Tysabri® and the cross motions to strike is set down for an oral hearing on 17 May 2023 after the briefing on Biogen’s motion was completed in April 2023.

In September 2022, Biogen filed a sealed complaint in the District of Delaware against Sandoz and Polpharma for infringement of 28 Biogen patents relating to Tysabri®.  Biogen filed an amended complaint on 30 November 2022, in which it had to reduce the number of patents it relied upon for the preliminary injunction (up to 5 patents and up to 10 claims).

February 28, 2023

Genentech has filed separate complaints against Biogen (in the US District Court Northern District of California) and Millennium (in the Superior Court of State of California) alleging breach of their respective licences to the Cabilly patents.  The Cabilly patents related to methods of manufacturing antibodies, and was one of the most widely licensed patent families in the biotechnology industry.  The last of the US pre-GATT filed “submarine” patents counterparts expired on 18 December 2018. 

The Complaint against Millennium (23-CIV-00924) alleges that Millennium’s Entyvio® (vedolizumab) product was manufactured in accordance with the Cabilly patents and royalties were paid to Genentech until the Cabilly patent expired.  Genentech argue that Millennium’s stockpile of Entyvio® which was manufactured before the Cabilly patents expired, but would be sold after 18 December 2018, constituted a “licenced product” and royalties are owed based on the sales of those products.  

The Complaint against Biogen (3:23-cv-909) is similar, but pertains to Biogen’s Tysabri® (natalizumab) product.  Genentech allege that Biogen also owe royalties based on sales of Tysabri® that were manufactured before the Cabilly patents expired but sold after.   

Genentech is unaware of the size of Millennium and Biogen’s respective stockpiles, but claims that they each owe Genentech “tens of millions of dollars in unpaid royalties”. 

2022

October 28, 2022

The Australian Pharmaceutical Benefits Advisory Counsel (PBAC) published the public summary documents from its July 2022 meeting.  Among the updates were:

  • Yuflyma® (adalimumab): recommended with ‘a-flagged’ status for the same indications as Humira®.
  • Tysabri® (natalizumab): amended listings (removing a requirement for neurologists prescribing natalizumab to be registered with the Tysabri Australian Prescribing Program) recommended by PBAC.
  • Epidyolex® (cannabidiol): not recommended for the treatment of Lennox-Gastaut syndrome, as the incremental cost effectiveness ratio was deemed to be unacceptably high at the price proposed.
  • Keytruda® (pembrolizumab): amended listings (increasing the max number of repeats, and maximum number of cycles in a lifetime) recommended by PBAC.
  • Stelara® (ustekinumab): vial for IV infusion and PFS recommended for the treatment of moderate to severe ulcerative colitis. 90mg/1mL PFS recommended for the treatment of Crohn disease and severe chronic plaque psoriasis.

October 27, 2022

Biogen is seeking a preliminary injunction in its proceedings against Sandoz commenced in September 2022 relating to natalizumab.  Biogen and Sandoz filed a joint stipulation and proposed schedule, seeking a preliminary injunction after 07 April 2023.  Biogen filed a sealed complaint against Sandoz and Polpharma in September 2022, alleging infringement of 28 Biogen patents.

September 9, 2022

Biogen filed a sealed complaint against Sandoz and Polpharma for infringement of 28 Biogen patents in the District of Delaware relating to Sandoz’s biosimilar natalizumab (Tysabri®).  Whilst the complaint was accepted under seal, Biogen was ordered to file a redacted complaint by 19 September 2022. Sandoz and Polpharma announced that they had entered into a licensing deal for Polpharma’s natalizumab biosimilar in September 2019, and the FDA accepted Sandoz’s ABLA for biosimilar natalizumab in July 2022.

July 25, 2022

Sandoz announced that the FDA has accepted its ABLA for a natalizumab biosimilar developed by Polpharma Biologics for all indications covered by the reference medicine Tysabri® including relapsing forms of multiple sclerosis (MS) – clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease in adults – and Crohn´s Disease.  The EMA accepted a MAA for the same product earlier this month.

July 15, 2022

Polpharma Biologics announced that the EMA has accepted its MAA for its biosimilar natalizumab for highly active relapsing-remitting multiple sclerosis with the same dosing, presentation and indication as Tysabri®.  Polpharma granted Sandoz commercialisation rights to Polpharma’s biosimilar under a global agreement announced in September 2019.

July 6, 2022

Biogen’s Tysabri® (natalizumab):  requesting removal of the clinical criterion which requires neurologists prescribing natalizumab under the PBS to be registered with the Tysabri Australian Prescribing Program

2021

April 7, 2021

Biogen announced the EC has granted marketing authorisation for Tysabri® (natalizumab) in a subcutaneous presentation. Tysabri® SC is approved for the treatment of relapsing-remitting multiple sclerosis.

2020

November 24, 2020

Novartis released its annual report ‘Meet Novartis Management 2020‘. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis has also indicated it  has planned launches for biosimilar adalimumab and natalizumab in 2021-2023 and denosumab in 2024-2026.

September 10, 2020

Neurology Advisor reported a new study indicates that natalizumab may be more effective than fingolimod or BRACETD in reducing relapses in patients with relapsing-remitting multiple sclerosis.

2019

November 18, 2019

Polpharma commences dosing in Phase III trials of proposed natalizumab biosimilar.

October 13, 2019

Polpharma publishes details of upcoming phase III clinical trials of biosimilar natalizumab candidate. The study will involve approximately 260 patients with relapsing-remitting multiple sclerosis.

September 3, 2019

Sandoz and Polpharma announced they have entered into a licensing deal for Polpharma’s natalizumab biosimilar.  Under the agreement, Polpharma will develop, manufacture and supply the product, while Sandoz will be responsible for commercialisation and distribution.

BioBlast® extract From September 3, 2019 to January 31, 2024