Novartis to wait for 180 days before selling itsFDA-approved biosimilar Enbrel: US court

The US Food and Drug Administration on Tuesday approved Novartis’s Erelzi as a biosimilarof Amgen’s Enbrel, which is a drug for the treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and other diseases. The Swiss based pharmaceutical company tried to sell its newly approved drug for $4.7 billion in yearly revenue, but sale was prevented by the US court.

The court wants Novartis to wait until 180 days from the approval to sell its biosimilar. The wait could postpone sales of Erelziuntil March next year. The company is planning to introduce the drug in the US market. This may affect Amgen, which has patent protection for its drug till 2029. Novartis’s first biosimilar was Zarxio. Novartis had to engage in a court battle with Amgen last year to get its approval.

Biosimilars copy biological products made inside living cells. Novartis is investing millions of dollars in the manufacturing of biosimilars in Austria and France. This way, the company provides affordable drugs copied from branded drugs. The drug-maker wants to attract insurers, healthcare systems and governments by offering cheaper drugs.

Erelzi is supposed to receive immense popularity for being a biosimilar of 2014’s world's fifth-biggest selling medicine. The European Medicines Agency is considering Novartis’s application that seeks approval for its biosimilar in the European markets. The US has approved the drug already, but before Novartis starts selling its copy drug, it should give 180-day-long notice to Amgen.

In the US, Erelzi is approved as more of a biosimilar than an interchangeable product. If a drug is approved as interchangeable product that indicates the drug approved has potential to generate results similar to the original drug. Biosimilar status for Erelzi indicates that the drug is very much similar to Enbrel and has no clinical differences.

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