LONDON, Sep 15 (APM) - Direct competition for Roche's blockbuster cancer drug Herceptin is on the way in Europe after regulators recommended on Friday a biosimilar version of the drug from Samsung Bioepis.
The biosimilar trastuzumab, known as Ontruzant, was one of two biosimilars recommended by the European Medicines Agency's advisory committee CHMP alongside Boehringer Ingelheim's Cyltezo, a version of AbbVie's Humira.
Ontruzant was recommended for approval in the EU for the treatment of early and metastatic breast cancer, and metastatic gastric cancer, according to the EMA's statement.
It is the first biosimilar trastuzumab product recommended in Europe, and only the second type of cancer biosimilar backed by the CHMP. Celltrion's biosimilar version of Roche's MabThera (rituximab), known as Truxima, became the first cancer biosimilar approved in Europe in February (APMMA 51929), followed by Novartis's version of the drug, known as Rixathon, in June (APMHE 53559).
The availability of direct competition will likely have a big impact on sales of Herceptin, which is one of Roche's biggest products, with revenues of 6.78 billion Swiss francs (5.90 billion euros) in 2016.
The market opportunity for Samsung Bioepis, a joint venture between Samsung and Biogen, will be even greater after the CHMP also said on Friday that Mylan has withdrawn its application for its biosimilar trastuzumab, known as Ogivri.
In its document the CHMP said its main concern was the lack of a valid certificate confirming that the manufacturing facility of the product complies with good manufacturing practice (GMP) requirements.
Mylan and its partner Biocon have also experience problems in the U.S., where in August, the Food and Drug Administration (FDA) delayed on a decision on biosimilar trastuzumab based on the same manufacturing issues (APMMA 54473).
The CHMP also backed Boehringer Ingelheim's biosimilar version of Humira (adalimumab). The drug, known as Cyltezo, is recommended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis.
A biosimilar version of Humira, formerly the world's biggest-selling drug, is already approved in Europe; Samsung Bioepis/Biogen's drug, known as Imraldi, was authorised in August (APMMA 54408).
However, patents in Europe on the drug are set to expire in late 2018 (APMMA 51559) (APMMA 51559), though this occurs later in the U.S. where Boehringer is fighting a patent battle with AbbVie after receiving approval for Cyltezo in August (APMMA 54454).
The CHMP also backed three generic drugs: Imatinib Teva B.V. (imatinib) for the treatment of leukaemia and gastrointestinal stromal tumours; Miglustat Gen.Orph (miglustat) for the treatment of mild to moderate type 1 Gaucher disease; and Ritonavir Mylan (ritonavir) for the treatment of HIV infection.
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