FDA Approves Erelzi™, the Third US Biosimilar Product

On Wednesday, August 30th, the FDA announced the approval of Sandoz’s Erelzi™ (etanercept-szzs).  Erelzi is biosimilar to Amgen’s Enbrel® (etanercept) and is indicated for the treatment of multiple inflammatory diseases.

Erelzi is the third biosimilar product approved by the FDA.  The product is administered by injection for the treatment of all five of Enbrel’s indications, which include:

  1. “Moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX).
  2. Moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older.
  3. Active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone.
  4. Active ankylosing spondylitis (an arthritis that affects the spine).
  5. Chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.”

According to an article from Biopharma-Reporter, a spokesman from Sandoz stated that the company “is fully committed to bringing Erelzi to US patients and payors ASAP.”  However, Sandoz is required to give Amgen a minimum of 180-days’ notice before launching the product commercially, meaning that Erelzi could be available as early as February of 2017.

In its announcement, FDA stresses the fact that Erelzi has been approved as a biosimilar to Enbrel, not as an interchangeable product.  This means that a pharmacist cannot substitute Erelzi for Enbrel without permission from the healthcare provider who originally prescribed Enbrel.  Both Zarxio™ and Inflectra , the only other two biosimilar products approved in the US, have also been deemed to be biosimilar but not interchangeable.

The industry continues to wait for clarification from the FDA regarding how to prove a product is interchangeable.  It will be interesting to watch as FDA provides this information, and as the first products are deemed interchangeable and additional products are approved as biosimilar.

Do you have a biosimilar or other FDA-regulated product in development?  We can help you develop your 315(k) BLA or any other FDA submission.  To learn more about how we can help you, contact us today.