FDA Approves Third Biosimilar

All information courtesy of Magellan, Rx 

ErelziTM, a biosimilar to Enbrel®, FDA approved
News Alert:

• On August 30, 2016, Sandoz (a Novartis division) received FDA approval for etanercept-szzs (Erelzi).
  
• This communication is preliminary based on information available at this time.
  Highlights:
  
  • Erelzi is biosimilar to Amgen’s reference product etanercept (Enbrel).
    
  • Erelzi is not interchangeable with Enbrel.
    
  • Erelzi – Third biosimilar approved in the U.S.
    
    • –  Sandoz’s filgrastim-sndz (Zarxio®) was the first (approved in March 2015).
      
    • –  Pfizer’s infliximab-dyyb (InflectraTM) was the second (approved in April 2016).
      
  • On July 13, 2016, the FDA’s Arthritis Advisory Committee panel voted 20 to 0, in favor of the FDA
    approving Erelzi across all indications of the reference product.
    
  • Per the FDA’s definition of a biosimilar, the tumor necrosis factor (TNF)-alpha inhibitor Erelzi has demonstrated no clinically meaningful differences to Enbrel in terms of the safety, purity, and potency.
    
  • The FDA’s approval was based on reviews of evidence ranging from analytical, nonclinical, and clinical data, to human pharmacokinetic data and other clinical safety and effectiveness data, which demonstrates Erelzi is biosimilar to Enbrel.
    
  • Erelzi indications:
    
    • –  Rheumatoid arthritis (RA)
      
    • –  Polyarticular juvenile idiopathic arthritis (JIA) in ages ≥ 2 years
      
    • –  Psoriatic arthritis (PsA)
      
    • –  Ankylosing spondylitis (AS)
      
    • –  Plaque psoriasis (PsO)
      
  • Erelzi was granted all of Enbrel’s indications.
    
  • Erelzi solution was approved as 25 mg/0.5 mL and 50 mg/mL single-dose (SD) prefilled (PF) syringes
    and as a 50 mg/mL SD PF pen.
    
  • Self-administered by subcutaneous injection.
    

Market Dynamics:

• Launch: To be determined, but not expected in the near future.
  
  • –  Under an August 11, 2016 court order, the manufacturers agreed to a preliminary injunction
    blocking the launch of Erelzi.
    
  • –  Depending on court rulings/patent appeals, there is a possibility of launch in 4Q2018 or April 2029.
    
• Price: To be determined. Market Impact:
  Erelzi marks the third biosimilar approved in the U.S. following Zarxio, also from Sandoz, and Pfizer’s Inflectra. However, the only biosimilar currently available on the U.S. market is Zarxio. The launch of Inflectra is pending. Erelzi is not interchangeable to Enbrel, since the FDA is still reviewing its guidance on interchangeability. The agency has also recently issued draft guidance for both nonproprietary naming and biosimilar labels. As the regulatory component evolves, there will be further clarity with biosimilar development and market adoption. Though approved, at the earliest, the market launch of Erelzi is not expected until 4Q2018. Court rulings and intellectual property considerations will ultimately impact Erelzi’s launch. Erelzi offers an alternative, potentially more affordable, treatment option to Enbrel for patients with select chronic autoimmune diseases. The pipeline of biosimilars is expected to grow. This competition will offer cost savings and an opportunity to improve patient access to critical medications.
  Magellan Rx Management Action:
  Magellan Rx Management is evaluating this new product and will follow up with clinical updates, management strategies, and financial guidance. Magellan Rx Management will also continue to closely monitor the biosimilar landscape and provide updates as appropriate.
  Links:
  

• FDA News Release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm.
  
• Novartis Press Release: https://www.novartis.com/news/media-releases/fda-approves-sandoz- erelzitm-treat-multiple-inflammatory-diseases.
  
• Erelzi Label: http://www.us.sandoz.com/cs/www.us.sandoz.com.wls10/assets/media/shared/documents/Erelzi_PI_ MG_IFU.pdf.