Biosimilar to Enbrel Receives FDA Approval

Erelzi, manufactured by Novartis, has just received FDA approval for treatment of rheumatoid arthritis. The drug is also approved to treat several other inflammatory conditions, including the skin condition plaque psoriasis. The drug, also known as etanercept-szzs, is a biosimilar version to Amgen Inc.’s anti-inflammatory medication, Enbrel. Biosimilar drugs are not completely interchangeable, and therefore, are not generics. However, they are so similar, that there are no clinically relevant differences between the two.
The reason they are not completely interchangeable, lies in the fact that they are biologic treatments. Biologic treatments, which are often used to treat inflammatory conditions, are made from living cells and can be incredibly difficult to copy and reproduce. Both of these biologics work in blocking TNF, or tumor necrosis factor, which plays a role in the inflammatory pathway.
The biosimilar drug created by Novartis received unanimous approval by the FDA this summer, however, not everyone was excited about the decision. Amgen’s Enbrel, which was put on the market in 1998, and currently generates $5 billion dollars a year, still has patent protection until 2029, which has led to many legal disputes. Amgen has been fighting to keep the new Erelzi off of the market. Although Amgen has been trying to halt the production of Erelzi, the company is in its own legal battle with pharmaceutical giant AbbVie for a similar situation. Amgen’s biosimilar to AbbVie’s Humira has been in dispute after AbbVie claims their drug is patent protected as well.
Regardless of all of these legal disputes, Novartis is committed to getting Erelzi on the market as soon as possible, in hopes of helping many individuals with RA and other inflammatory conditions. Global head of biopharmaceuticals at Novartis’ Sandoz unit in Germany, Carol Lynch, has recently said, “we are committed to bringing Erelzi to the US market as soon as possible.” Hopefully, the process will move forward in the near future, allowing a new treatment to break into the market!

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