Following the announcement of Amgen’s submission of a biologics license application (BLA) for its infliximab biosimilar candidate, ABP-710,

Rose Joachim, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the future prospects of ABP-710, if approved in the US:

“Considering that Amgen will not be able to launch its adalimumab biosimilar, Amjevita, in the US until 2023, it is a smart move for the company to begin to establish itself in the US biosimilars market as soon as possible.

“Despite the effects of the growing JAK inhibitor class on infliximab market-share, GlobalData expects that demand for infliximab in the rheumatoid arthritis, inflammatory bowel disease (IBD), and psoriasis markets will remain fairly stable. Based on GlobalData’s analysis, the overall patient pool receiving the drug in the US will decrease only 5% – 6% by 2026 across these indications. During that time, GlobalData expects a shift of at least 60% from branded to biosimilar infliximab and estimates total infliximab revenue in these markets to total about $3.6bn.

“Although there is a sizeable infliximab market for Amgen to tap into, ABP-710 will face serious competition as a third-to-market infliximab biosimilar. In order to succeed, Amgen needs a comprehensive strategy to differentiate its product. Case in point: Pfizer’s Inflectra has continued to dominate the infliximab biosimilar market, despite launching only 8 months before Merck’s Renflexis. Other developments that may hamper uptake of ABP-710 include Merck’s national contract to provide discounted Renflexis to the Department of Veteran’s Affairs and Celltrion’s endeavours to gain approval for subcutaneous Inflectra, the first subcutaneous formulation of infliximab.

“While the competition may be fierce, Amgen has a very important asset that may help it compete in the US market—Enbrel. Amgen may seek to form contracting agreements with pharmaceutical benefits management (PBM) companies that leverage discounts on Enbrel in exchange for more favorable coverage of ABP-710. With Enbrel biosimilars not expected to launch in the US until 2028, Amgen will have a decade’s worth of bargaining power on its side.”