Update (19/06/2017): The EMA has cleared Sandoz’ Rixathon, a biosimilar to rituximab, making it the second oncology biosimilar in the EU. Novartis’ fourth EMA-approved biosimilar is set to unlock the billion-euro blood cancer and rheumatoid arthritis markets.


Originally published on 24/04/2017

Novartis just received positive CHMP opinions for its blockbuster biosimilars, getting ready to unlock two massive markets.

As biosimilars are set to take on the profitable biological markets, Novartis subsidiary Sandoz is taking the next steps to launch two new biosimilars in the EU. The company already has three biosimilars on the market and now announced that the Committee for Medicinal Products for Human Use (CHMP) is separately recommending the approval of both Sandoz’ biosimilar to rituximab and its biosimilar to etanercept in Europe, unlocking access to billion-euro arthritis and cancer markets.

Novartis and Sandoz have been pioneering the biosimilar field and scored the first-ever biosimilar approval in Europe with Omnitrope (somatropin) already a decade ago. Novartis recently affirmed its position, when it got FDA approval for etanercept biosimilar Elrelzi. The drug is a generic version of Amgen’s Enbrel, a TNFα inhibitor that treats rheumatoid arthritis as well as psoriatic arthritis, plaque psoriasis and ankylosing spondylitis and which racked up €5.5B in sales in 2016.

Sandoz_Biosimilars

Biosimilars marketed by Novartis and Sandoz.

Not surprisingly, Amgen is not letting go of its top-seller and has responded with a patent infringement suit based on several new patents the company won back in 2011. In Europe, however, Novartis is not the first one to copy Amgen’s cash cow. In January 2016, Biogen and Samsung Bioepis secured marketing approval for their biosimilar from the EMA, marking the first approval of an Enbrel biosimilar in Europe.

Novartis’ second biosimilar receiving positive feedback from the EMA mimics Roche’s blockbuster drug Mabthera (rituximab). The antibody binds to the CD20 molecule found on B cells and is used for the treatment of B cell leukemias and lymphomas as well as B cell-associated autoimmune diseases such as Rheumatoid Arthritis.

After Roche’s patent expired in 2015, the biosimilar competition has been lining up – but even if Novartis snags EMA approval for its biosimilar, the company would still come in behind Celltrion. Celltrion’s rituximab copy Truxima was recently approved by the EMA as the world’s first biosimilar with an oncology indication and both Amgen and Pfizer have their biosimilars in development.

The rapidly growing biosimilar market is definitely becoming crowded these days and Novartis will have to face a lot of competition on the market. 


Images via shutterstock.com / HQuality and Sandoz.com

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