FDA advisers back Amgen's Humira biosimilar
AbbVie’s top-selling Humira (adalimumab) is set to face competition in the US, after advisers to the country's regulator unanimously recommended that Amgen’s near-copy should be approved.
Humira, a monoclonal antibody approved in a range of indications such as rheumatoid arthritis, is expected to generate sales north of $15 billion this year. making it the world's biggest selling drug.
Last year, sales topped $14 billion, with the US accounting for around 60% of sales.
The US Food and Drug Administration's Arthritis Advisory Committee voted 26-0 in favour of approving Amgen’s ABP 501 following a glowing report from the regulator’s staff.
The FDA said that Amgen had provided data showing ABP 501 is “highly similar” to Humira and that it can be manufactured to consistently meet quality standards.
Biosimilars are cheaper near-copies of biological drugs made in cells, and under US laws, drugmakers must produce a dossier of data showing that there is almost no difference between their copy and the original branded drug.
Amgen used EU Humira data to support its filing, using a procedure agreed by the FDA and the European Medicines Agency that prevents the need for costly duplicate clinical trials either side of the Atlantic.
Advisory committees’ decisions are not binding, but the FDA usually follows their lead, and is set to make a final decision before a target date of 25 September.
ABP-501 could become the second monoclonal antibody biosimilar approved in the US, after the FDA gave the green light for Celltrion’s rival to Johnson & Johnson’s Remicade (infliximab).
AbbVie is trying to block rivals coming to market as although the drug’s main US patent expires late this year, it has set up a thicket of other patents that could provide protection until 2022.
Amgen could launch its drug before this date, or before it wins any court action to cut Humira's exclusivity period, but may have to pay damages if it ultimately loses the legal battle.
Some analysts are forecasting that the drug will be available well before 2022, and expect Humira sales to drop by up to 18% percent in 2019.
The European Medicines Agency is also reviewing ABP 501.
Celltrion's Remicade biosimilar has not been launched either because of a similar legal defence and J&J bullishly predicted that there would be no biosimilar competition this year.
