Biologics and Biosimilars Bits and Bytes – November 30, 2015

As our BRIC Wall readers are aware, biologics and biosimilars are becoming more newsworthy and noteworthy around the world. To help our readers stay current, we are introducing a new feature – Biologics and Biosimilars Bits and Bytes – to provide periodic updates on the most significant developments. We hope you find this new feature informative.

Amgen Files for First U.S. Approval of a Biosimilar to AbbVie’s Humira®

On November 25, 2015, Amgen filed a 351(k) application with the U.S. Food and Drug Administration (FDA) for ABP 501, a biosimilar version of AbbVie Inc.’s (AbbVie) Humira® (adalimumab). The filing was noteworthy not only because it is believed to be the first biosimilar application filed in the U.S. for adalimumab, but also because it was Amgen’s first submission of any biosimilar application to the FDA.

Adalimumab is a human monoclonal antibody that is used to treat autoimmune diseases. It works by binding to tumor necrosis factor (TNF)-alpha preventing it from activating TNF receptors (which cause the inflammatory reactions associated with autoimmune diseases). Adalimumab has been approved for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis. In 2014, worldwide sales reached almost $13 billion.

According to Amgen, its submission included analytical, clinical and pharmacokinetic data. Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. These studies met their primary endpoints demonstrating clinical equivalence to adalimumab. Additionally, the submission also included data to support the switching of adalimumab patients to ABP 501.

In addition to Amgen, a number of other companies are developing biosimilar versions of adalimumab. These include: Boehringer Ingelheim (for BI695501), Baxalta and Momenta Pharmaceuticals (for M923), Samsung Bioepsis (for SB5) and Oncobiologics (for ONS-3010).

The EMA Recommends the first Enbrel® Biosimilar for Approval In Europe

On January 21, 2015, Samsun Bioepis, a joint venture between Samsun Biologics and Biogen, filed for approval of Benepali™ (etanercept), also known as SB4, by the European Medicine Agency (EMA). On November 19, 2015, the EMA’s Committee for Medicinal Products for Human Use (CHMP), recommended Benepali™ for marketing authorization. If approved, this will bring the first biosimilar of Enbrel® to market in Europe.

Etanercept is a fusion protein that inhibits the activity of tumor necrosis factor alpha. The CHMP recommended Benepali™ for use:

  1. In combination with methotrexate for treatment of moderate to severe rheumatoid arthritis in adults that have an inadequate response to disease-modifying anti-rheumatic drugs, including methotrexate;
  2. Alone in adults intolerant to methotrexate or when continued treatment with methotrexate is not appropriate;
  3. In the treatment of active and progressive psoriatic arthritis in adults who fail to respond to disease-modifying anti-rheumatic drugs;
  4. In the treatment of severe active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy;
  5. In the treatment of severe nonradiographic axial spondyloarthitis with objective signs of inflammation in adults who have had an inadequate response to nonsteroidal anti-inflammatory drugs; and
  6. In plaque psoriasis in adults with moderate to severe psoriasis who fail to respond to, who have a contraindication to, or who are intolerant to other systemic therapy (such as ultraviolet A light, methotrexate, psoralen, ciclosporin, etc.).

The CHMP’s recommendation will now be referred to the European Commission which grants approval for the European Union, Iceland and Norway. Final approval is anticipated by February 2016. Once final approval is received, Benepali™ will be commercialized in Europe and Switzerland by Biogen which also holds the commercialization rights in Japan. Merck & Co. will commercialize in all other markets except the U.S.

This post was written by Lisa Mueller.

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