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Celltrion’s Rituxan biosimilar wins European approval

Discussion in 'Rituximab: News and Research' started by deleder2k, Feb 23, 2017.

  1. deleder2k

    deleder2k Senior Member

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    South Korea’s Celltrion announced Wednesday that the European Medicines Agency has granted sales approval to Truxima, its biosimilar drug referencing Roche’s blockbuster lymphatic cancer drug Rituxan.

    Truxima is the first ever Rituxan (rituximab) biosimilar to be approved by the European drug regulator, as well as the first ever Europe-approved biosimilar monoclonal antibody used to target cancer.

    Biosimilars are cheaper, near replicas of living cell-based biologic drugs whose patents have expired. The recent emergence of these alternative drugs have begun to threaten the exclusivity of some of the world’s top selling pharmaceuticals, held by a handful of global pharma giants.

    [​IMG]
    The EMA has approved Truxima for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

    With the approval, Truxima can now be sold at 28 European Union member states including the UK, Germany, Italy, France and Spain as well as Norway, Iceland and Lichtenstein.

    Celltrion said it would continue to work with its marketing partners for Europe -- including Mundipharma, Biogaran and Kern Pharma -- to begin selling Truxima across Europe from the second quarter, starting with the UK.


    “We expect Truxima to secure a strong competitive edge in the global market for monoclonal antibody drugs as it faces no competitors other than the original drug Rituxan,” Celltrion said in a statement.

    Truxima is likely to be the only Rituxan biosimilar in the market for the time being, though competing drugs are on their way.

    Novartis-owned Sandoz submitted its own biosimilar referencing Rituxan to the EMA for approval in May 2016, while Pfizer and Amgen are wrapping up third-phase clinical trials of their own Rituxan biosimilars.

    Truxima is Celltrion’s second biosimilar to be commercialized in Europe. The Korean drugmaker began selling Remsima, its biosimilar referencing Remicade, in Europe in February 2015 and in the US (sold as Inflectra) from November 2016.

    Rituxan, also sold as Mabthera, was originally developed by Biogen and is sold globally by US pharmaceutical giant Roche. It is the world’s second top-selling drug, having generated sales of more than $7 billion last year.

    Celltrion plans to file Truxima for review by the US Food and Drug Administration by early next year as well, with hopes of becoming the first to introduce a Rituxan biosimilar in the US.

    In addition to Remsima and Truxima, Celltrion is currently seeking the EMA’s approval of another biosimilar drug called Herzuma -- referencing Roche’s Herceptin. The Korean drugmaker plans to file the drug for approval by the US FDA as well.

    Celltrion holds high expectations for its three biosimilar drugs -- all of which are or will become the first biosimilar versions of their respective originator drugs to enter major markets.

    “Together, the three originator drugs targeted by our biosimilars account for a global market worth around 25 trillion won ($21.5 billion),” Celltrion said.

    “By selling our products at 30-40 percent discounted prices, we can target a market worth at least 15-17 trillion won. And capturing just 20 percent of this market will amount to sales of more than 3 trillion won within 2-3 years,” it said.



    http://www.koreaherald.com/view.php?ud=20170222000795
     
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  2. jaybee00

    jaybee00

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  3. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    Thanks, very welcome news. Good to see PR members first with the news as ever. I had not heard of this.
     
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  4. barbc56

    barbc56 Senior Member

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    Are biosimilar drugs the same as generic drugs?

    Edit.

    Just found this. Quite interesting.

    .

    http://www.amgenbiosimilars.com/the-basics/biosimilars-versus-generics/
     
    Last edited: Feb 23, 2017
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  5. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    Broadly, yes, but as you noted more stringent quality control is needed for generic biological drugs. Interestingly, a company that has a patent on 'blobbimab' can change the way it makes the drug and still sell it as blobbimab. But any company that does not have the patent can only call their drug a biosimilar even if they make it exactly the first way the first company made blobbimab. So 'biosimilar' is a commercial category rather than a chemical category.

    In practice it turns out that generic biological drugs do run a greater risk of being no good because of the complexities of biological production, but there have been some dodgy generics for small molecule drugs too. I think it likely that the assessors for licensing know enough about the technicalities to make sure that if a biosimilar is licensed it is as likely to be OK as anything made by the patentee company. But note that there are some biosimilars around that did not get approved.
     
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  6. deleder2k

    deleder2k Senior Member

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    @Jonathan Edwards, thanks for your comments.

    Would you be comfortable in swapping Mabthera with Truxima after the EMA approval to treat R.A? Would you recommend that a U.K rituximab trial used it to save money?
     
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  7. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    I think it would be reasonable to switch to Truxima for RA if Roche do not bring their price down to match (which they may well do). I would probably not recommend using Truxima in trials for ME until primary evidence of efficacy is established. Once it is then a dose ranging study with Truxima would make sense.
     
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  8. Gingergrrl

    Gingergrrl Senior Member

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    USA
    From an allergy perspective, would the biosimilar drug be identical to the original in re: to inactive ingredients, dyes, fillers, etc?
     
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  9. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    Generally speaking I think biological drugs are pure freeze dried drug with no additives. There are no dyes or fillers. There may be preservatives or stabilisers but I suspect these would be the same.
     
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  10. Demepivo

    Demepivo Dolores Abernathy

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    Good to hear...any recent posts on the UK Rituximab trial?
    (will it actually happen soon?)
     
  11. deleder2k

    deleder2k Senior Member

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    It is listed on MIMS now. 500mg/50ml vial = 785.84 Sterling, while Mabthera Rituximab is listed at 873.15. I was hoping for a more significant reduction in price.

    I don't know if this is the NHS negotiated price. I don't know how the British system works.

    Source: www.mims.co.uk/drugs/musculoskeletal-disorders/rheumatoid-arthritis-other-autoimmune-disorders/truxima


    There is also an information brochure called "Answers to commonly asked questions about biosimilar versions of rituximab" which is available here: https://www.sps.nhs.uk/wp-content/uploads/2017/04/biosimilar-rituximab.pdf


    https://www.celltrion.com/en/pr/reportDetail.do?seq=425
     
    Last edited: May 4, 2017
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