The Real McCoy or Poundstretcher CD20 antibody

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Comparison of rituximab originator (MabThera®) to biosimilar (Truxima®) in patients with multiple sclerosis. Perez T, Rico A, Boutière C, Maarouf A, Roudot M, Honoré S, Pelletier J, Bertault-Peres P, Audoin B. Mult Scler. 2020 Mar 17:1352458520912170.

BACKGROUND:Rituximab’s originator MabThera® or Rituxan® has demonstrated high efficacy in multiple sclerosis (MS). Because of the patent expiration, rituximab biosimilars have been developed. (Well possibly because of patent expiration ocrelizumab was perhaps developed). However, because a biosimilar is not the exact copy of the originator, the efficacy and safety of a biosimilar may significantly differ.

OBJECTIVES: To compare the efficacy and safety of the biosimilar Truxima® and the originator MabThera® in MS.

METHODS:Consecutive MS patients receiving MabThera® or Truxima® were prospectively followed during 1 year after treatment introduction. Allocation to each treatment depended on the period of introduction and not the physician’s choice. Lymphocyte count, clinical and magnetic resonance imaging (MRI) activity, Expanded Disability Status Scale (EDSS), and adverse events were compared.

RESULTS: In total, 105 and 40 patients received MabThera® and Truxima®, respectively. The two groups did not differ in baseline characteristics. Effect on CD19+ lymphocytes and disease activity were similar during follow-up. EDSS remained stable, with no difference between groups. Adverse events were similar between groups.

CONCLUSION:The efficacy and safety of the rituximab biosimilar Truxima® seem equivalent to the originator MabThera® in MS patients. Truxima® could represent a relatively cheap and safe therapeutic alternative to MabThera® and could improve access to highly efficient therapy for MS in low- or middle-income countries.

DrAngry has something to say on this one and will show bargain bucket is not always the bargain you think about. Maybe DrA will a have time to get this out whilst we are on enforced holiday……nudge nudge.

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MouseDoctor

11 comments

  • “Actually because of patent expiration ocrelizumab was developed”. NO it is not. Actually Ocrelizumab wasn’t developed by Roche but Biogen instead. As far as I know it is just licensed to Roche.

    • This is a hypothesis. I have changed the wording as I have no inside knowledge and there are no doubt many reasons why ocrelizumab was developed rathèr than rituximab.. you are correct that to Roche and Biogen idec developed the drug

    • Thanks I was looking for rituximab references.This may be of use.

      Rituximab was developed by researcher Nabil Hanna and coworkers at IDEC Pharmaceuticals under the name IDEC-C2B8. The U.S. patent for the drug was issued in 1998 and expired in 2015. Check out patent Anderson DT, Rastetter WH, Nabil H, Leonard JE, Newman EA, Reef ME. 1994. Therapeutic application of chimeric and radiolabeled antibodies to human B lymphocyte restricted differentiation antigen for treatment of B cell lymphoma. WO9411026.

      If interested patent search at Espacenet

      Therefore Rituximab was a IDEC drug and IDEC merged with Biogen to be Biogen-IDEC

      Rituximab was developed in the US by Genentec and Biogen-IDEC. I am therefore guessing that Genetec was interested in developing rituximab for the cancer market and it markets rituximab in the US. Genetec is wholly owned by Roche and Roche market Rituximab outside of the US and Chugai in Japan.

      Ocrelizumab is a a humanised antibody that was based on a mouse monoclonal called 2H7 and this was invented by Genetec (Roche). Check out
      Patent Adams CW, Chan AC, Crowley CW, Lowman HB, Nakamura GR, Presta LG. Immunoglobulin variants and uses thereof. WO2004056312. 2004.

      Therefore ocrelizumab is a Genetec drug and Biogen was interested based on its interest in MS.

      Biogen Idec, which originally funded trials for ocrelizumab, has changed its name to Biogen (23 March 2015)
      The phase III clinical trials have been funded by Hoffmann-La Roche Ltd and Biogen Idec. Genentech, a wholly-owned member of the Roche Group, is now fully responsible for development and commercialization of ocrelizumab in MS; Biogen Idec will receive royalties on sales of ocrelizumab in the US (21 October 2010). http://www.msdiscovery.org/research-resources/drug-pipeline/550-ocrelizumab.

      The original rituximab phase II was reported in 2008, with a 5 year plan for phase III trials and doing the regulatory work up we would havebeen near 2015. Orcelizumab phase II were reported in 2011 (so a three year delay by switching), the Phase III were reported in 2017 and ocrelizumab was approved for use in MS in US in 2017. So if rituximab was developed you may have had a patent life of a year.

      Ocrelizumab has at least ten years more patent life than rituximab and may expire in 2023 I believe so 6 years of market exclusivity, it is making a few billion a year.

      Therefore the idea that rituximab was dropped in favour of ocrelizumab would not be inconsistent with the idea of patent life was important.
      Ofatumumab was acquired by Novartis. For cancer ofatumumab is an infusion, you can bet that the subcutaneous dosing is protected by a patent and taht will extend the life of ofatumumab in MS, well beyond the life of the original ofatumumab patent.

  • Before starting Ocrelizumab I searched the literature for a reason why this biosimilar was created to replace Rituximab and couldn’t find one. It’s good to see somebody verbalising my conclusion in print. Inexpensive biosimilars have replaced Rituximab in lots of other rheumatoid disease and R-CHOP chemotherapy successfully. As CoVID-19 places increased financial pressure on healthcare systems around the world, we need this kind of work to maintain optimal MS treatment.

    • However is the manufacture as good. If there are aggregates it will be more immunogenic. I don’t have any information to say they are not as good as we each other.

    • Why biosimilars…As Jesse J almost says….Its all about the money, money.

      If you have a billion dollar seller, even it you get a fraction of this, it is worth a lot.But will people stick with the brand many people will…when I could find a £0.50 generic parcetomal for Head Ache I bought a £3.5 p***adol , £3 for some cardboard. However if you live somewhere where the cost of the brand is outside most peoples reach,the biosimilars make drug options for people who wouldnt have one.

      If we wanted to make rituximab we could do it as the sequences are there in the patent, indeed DrAngry has been desigining away and we could make something news

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