FDA Approves Novartis’s Biosimilar Version of Enbrel

FDA approved Sandoz’s etanercept-szzs biosimilar product to Amgen’s Enbrel Tuesday (Aug. 30), bringing the total amount of FDA-approved biosimilars to three.

Erelzi will be allowed for use in patients with moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and moderate to severe plaque psoriasis.

In July, the FDA Arthritis Advisory Committee unanimously recommended approval of the biosimilar.

The approval of Erelzi was supported by review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic (PK) and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and efficacy data that showed Erelzi was biosimilar to Enbrel.

Erelzi is also now being reviewed in Europe, where the first biosimilar version of Enbrel, made by Samsung Bioepis, was approved earlier this year.

Novartis’s Sandoz plans to roll out five major biosimilars by the end of the decade, including versions of Enbrel and Neulasta, AbbVie Inc.’s Humira and Roche Holding AG’s Rituxan – biologics that generated about $44 billion in 2015 sales globally, the company said in June.

The US biosimilar market is still in its infancy with just two products approved to date, namely Zarxio and Pfizer’s Inflectra, a version of Johnson & Johnson’s TNF inhibitor Remicade (infliximab) that is sold as Remsima in other markets. “As a global leader with over a decade of experience in commercialising biosimilars in highly-regulated markets around the world, we have tremendous experience to draw on”. They are similar to generics but made with living organisms and aren’t identical to the complex compounds they replicate.

An application for the biosimilar also has been accepted by the European Medicines Agency and is now undergoing review. Another Boxed Warning alerts patients about the increased risk for serious infections that can lead to death. The target, Enbrel, is Amgen’s biggest drug with $5.36 billion in sales past year.

Under a court order dated August 11, Amgen Inc. and Sandoz, a unit of Novartis, agreed to a preliminary injunction blocking the launch of Erelzi. “Sandoz is proud to have developed two of the three biosimilars that are now FDA approved, which further demonstrates our commitment to U.S. patients in a growing number of therapeutic areas”.

Generic drugmakers have typically operated as distinct from their branded counterparts, although the lines have blurred in recent lines. In an August 11 ruling, a USA federal judge in New Jersey blocked Sandoz from selling its version.