Celltrion’s Rituxan biosimilar wins European approval

deleder2k

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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.

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
 

barbc56

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Are biosimilar drugs the same as generic drugs?

Edit.

Just found this. Quite interesting.

.Biosimilar manufacturers will generally need to generate data from lab testing, non-clinical testing and clinical testing to show that the biosimilar they have developed will provide the same therapeutic benefit and risks to patients as the reference product
.

http://www.amgenbiosimilars.com/the-basics/biosimilars-versus-generics/
 
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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/
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.
 

deleder2k

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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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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.
 

Gingergrrl

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

deleder2k

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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


It is not yet clear what the NHS contract price of Truxima® will be but based on current expenditure on MabThera® it is estimated that even a 50% switch to a biosimilar version marketed at 70% of the price of Mabthera® would reduce overall expenditure on this medicine by over £21m in England which equates to about £40,000 per 100,000 population.
Press release:

- Truxima™ has been supplied to about 50 hospitals in England …Administration of the drugs to the patients with hematoma and rheumatoid arthritis has been completed

- Switching of medication to some of the patients … positive market response following the first appearance of Rituximab biosimilar


[18, April, 2017] Celltrion presented starting official sales of its second biosimilar, Truxima™, which was approved by the European Medicines Agency (EMA) in England.


Truxima™ is an antibody biosimilar used in treatments of Non-Hodgkin lymphoma which is a kind of hematological cancers and rheumatoid arthritis.

Celltrion received approval for Truxima™ sales by the Ministry of Food and Drug Safety in Korea last November, and also by European Medicines Agency (EMA) in February this year.


Since last April, Celltrion has provided Truxima™ to about 50 hospitals in England with its affiliate, Celltrion Healthcare, which is in charge of overseas marketing for the company products, and with Napp Pharmaceuticals Ltd, the distribution partner in England; also, at each hospital, hundreds of blood cancer and rheumatoid arthritis patients were confirmed to have completed their first Truxima™ administration.Among these patients, they included the patients switched to Truxima™ from originator infliximab.



A Celltrion official said “Despite it’s early stage of launching, positive market sentiment for Truxima™ has been detected in Europe. With the advent of the first biosimilar of anticancer in Europe, patients all around the world, medical care and pharmaceutical makers are paying keen attention to the market reaction.” The company plans to increase the market share to block the entry of competitors, while increasing the confidence of the medical community based on accumulated prescription data.” The expert also added, “We will try to obtain licenses and sales for Truxima™ in the United States and other countries as soon as possible so that patients around the world can benefit from the biosimilar.,”
https://www.celltrion.com/en/pr/reportDetail.do?seq=425
 
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