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Drug Information Update- Amjevita (adalimumab-atto)

New Drug Approval:

On September 23rd, 2016 the FDA approved Amjevita (adalimumab-atto), a biosimilar for Humira, for rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (PsO) in adults.  In patients four years and older, Amjevita is indicated for polyarticular juvenile idiopathic arthritis(JIA). 

Prescribing information is available here.

Drug Overview and Place in Therapy:

Amjevita is the first approved biosimilar to Abbvie’s Humira and is approved for seven of the ten indications that Humira is currently approved for.  The indications that are not present in the Amjevita label are:  pediatric Crohn’s disease, hidradenitis suppurativa (HS) and uveitis (UV).  The labels also differ in that the Humira JIA indication allows for treatment of patients 2 years and older. 

MedImpact is in communication with the manufacturer regarding the future availability of Amjevita. Biosimilars are subject to a 180-day waiting period after approval before they can be marketed.  This waiting period does not take into account patent litigation that may further delay introduction to market. Amgen (the manufacturer of Amjevita) and Abbvie (the manufacturer of Humira) are currently in litigation which will likely lead to a delay in the launch of Amjevita.  In 2015, Abbvie reported that sales of Humira were roughly $8.4 billion in the United States.  The sales of Humira globally accounting for 61% of the Abbvie’s total net revenue in 2015.  Amgen has not released pricing for Amjevita. We predict that Amjevita will come in roughly 15% less than the originator product. 

With the first biosimilar approved, Zarxio, a biosimilar to Neupogen, the time from FDA approval (March, 2015) to market release (September, 2015) was 180 days.  The product was priced modestly lower than Neupogen and cost savings were negated when rebates were taken into consideration.  The second biosimilar Inflectra, biosimilar to Remicade, was approved in April 2016 and will be introduced to the US market in the fourth quarter of 2016.  Inflectra will be priced at 15% less than Remicade, the originator product

The regulatory pathway for biosimilars is plagued with questions and concerns regarding interchangeability of biologic products.  Currently no biosimilar products, including Amjevita, are deemed as interchangeable. Even if the FDA recognized a biosimilar as interchangeable, individual State Boards of Pharmacy can establish interchangeability laws. 

MedImpact is monitoring several potential biosimilar products for Neupogen, Neulasta, Enbrel and Humira that are under review at the FDA. (See Table 1 below). The FDA has been reviewing many of the biosimilar products for longer than the standard review timeframe.  Predicting the entrance of new biosimilars is challenging due to delays in the process and ongoing patient litigation.    

Utilization Management Strategies:

A full clinical review of Amjevita was conducted at the MedImpact 3rd Quarter 2016 Pharmacy & Therapeutics Committee Meeting on August 5th, 2016.

Upon receiving pricing information and reviewing effective cost management strategies, including manufacturer rebate opportunities, MedImpact will make final recommendations regarding formulary placement and utilization management.

 

Please note: The views expressed in the above reflect the opinions of the MedImpact Drug Information team.

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