Third approval flows from U.S. biosimilar pipeline

The FDA approved its third biosimilar Tuesday: Sandoz Inc.'s Erelzi, a biosimilar to Amgen Inc.'s Etanercept.

As it has with the first two biosimilars, the agency approved an extrapolated label, licensing Erelzi for all of Etanercept's indications – rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. The follow-on was tested in plaque psoriasis against the EU-licensed version of Enbrel, with a bridging study to the U.S. version.

The FDA's approval follows the advice of its Arthritis Advisory Committee, which voted unanimously last month to recommend approval of the Sandoz biosimilar. (See BioWorld Today, July 14, 2016.)

Like Enbrel, which was first licensed in 1998, Erelzi will have a boxed warning to alert health care professionals and patients about an increased risk of serious infections and lymphoma and other malignancies. Also like its reference product, the biosimilar must be dispensed with a patient medication guide describing important information about its uses and risks, according to the FDA.

In keeping with draft guidance it issued a year ago, the agency assigned the new biosimilar a proper, or nonproprietary, name that consists of the core drug substance and a unique, four-letter alphabet soup suffix – etanercept-szzs. (See BioWorld Today, Aug. 28, 2015.)

It's the second biosimilar to get the nonsense suffix. Celltrion Inc.'s biosimilar to Remicade (infliximab, Janssen Biotech Inc.), to be marketed as Inflectra in the U.S. by Pfizer Inc., was given infliximab-dyyb as a proper name. But Sandoz's Zarxio (filgrastim-sndz) was approved before the draft guidance was released. (See BioWorld Today, March 9, 2015, and April 13, 2016.)

Sandoz, a division of the Basel, Switzerland-based Novartis Group, said it plans to launch Erelzi as soon as possible. That could be awhile, though.

Now that the biosimilar is approved, Sandoz has to serve Amgen with a notice of commercial marketing and wait 180 days before launching the biosimilar to give Amgen time to assert relevant patents.

Enbrel is protected by a thicket of patents, many of which won't expire for 10 to 20 years. Thus, there's bound to be more lawsuits between Amgen and Sandoz. The two are still waiting to see if the U.S. Supreme Court will wade in on legal questions they raised in an appeal of a Federal Circuit ruling concerning Zarxio, which references Amgen's Neupogen, and the timing of the provisions in the Biologics Price Competition and Innovation Act.

Meanwhile, Sandoz, which is differentiating itself as the "global leader in biosimilars," said its etanercept biosimilar is undergoing review by the EMA, and the company hopes to have several other biosimilars approved by 2020.

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