Amgen US Humira biosimilar arrives five months ahead of the pack

Amgen has launched Amjevita with a two-tier list price strategy offering the biosimilar at discounts of 55% and 5% over AbbVie’s Humira (adalimumab).

After 20 years and over $200 billion of sales, AbbVie’s anti-TNF-α monoclonal antibody Humira is facing competition in the US with the launch of Amjevita.

“Today, we announced the launch of Amjevita, the first US biosimilar to Humira, a medicine used by more than 1 million patients living with serious inflammatory diseases,” Amgen’s EVP of Global Commercial Operations Murdo Gordon said on a conference call yesterday.

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“With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to supply patients with this biosimilar medicine. Amjevita is the first significant US biosimilar in the pharmacy benefit space and we expect gradual uptake in the coming months as this market evolves.”

While there are 10 players with approved biosimilars in the US this year, Amgen has a five month window of exclusivity ahead of its rivals due to a 2017 settlement with AbbVie. The other biosimilars set to launch from end of June are marketed by Alvotech, Boehringer Ingelheim, Coherus, Fresenius Kabi, Mylan, Pfizer, Organon, Sandoz, Viatris.

To capitalize, Amgen has launched a two-tier pricing system, offering Amjevita both at a list price (Wholesale Acquisition Cost) 55% and 5% below the current Humira list price.

“This is really to address the complexity of the US market,” said Gordon. “Pharmacy benefit managers have a business model that requires that they negotiate rebates with manufacturers, and so they would prefer a high list price and negotiate rebates to net the price down and then pass those rebates through to their upstream employer clients.”

He added: “There are other stakeholders and customers in the health care system that prefer a net price-based model and don’t care about the difference between list and net or gross price and net price. And so for those, we have the lower net price product available.”

Amgen hopes Amjevita will mirror the success seen with Amgevita, its adalimumab biosimilar in Europe. Amgevita launched in 2018 and, according to management, is “the most prescribed adalimumab biosimilar in Europe.”

For the full year, Amgevita clocked in sales of $460 million, up 5% year-on-year, including a record $119 million in Q4.