Adalimumab Biosimilar Passes Phase III. State Lawmakers Paying Attention

February 6, 2015

Amgen has announced success in a Phase 3 trial of an adalimumab biosimilar. The subject of biosilimars is already "trending" in state legislatures, 10 of which now mandate notification of substitution.

Amgen has publicized results of a Phase 3 study of a biosimilar to adalimumab[[{"type":"media","view_mode":"media_crop","fid":"31834","attributes":{"alt":"biosimilars","class":"media-image media-image-right","id":"media_crop_758390251176","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"3359","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"width: 187px; height: 155px; float: right;","title":" ","typeof":"foaf:Image"}}]] (Humira) showing that it met safety and efficacy endpoints in a randomized double-blind trial comparing the two drugs in patients with moderate-to-severe rheumatoid arthritis.

An Amgen official told Rheumatology Network that the full results will be presented "at a rheumatology congress later this year." Amgen declined to say where these study subjects reside, but its listing on a European clinical trials database mentions 7 European countries, the Russian Federation, Argentina, Mexico, and the UK, as well as the US and Canada.

The 562 patients were randomized to receive 40 mg of the biosimilar or adalimumab subcutaneously every 2 weeks for 22 weeks, followed by a 4-week safety follow-up period. The primary endpoint was ACR20 status at 24 weeks.

Amgen says it has nine biosimilar molecules in development and expects to launch five of them within the next 4 years.

So far 10 states have introduced legislation related to substitution of biosimilars, according to the American College of Rheumatology's RheumWatch, and another nine are expected to follow. Most legislation specifies that the biosimilars must be deemed interchangeable by the FDA, offer a "dispense as written" option to prescribing physicians, and mandate patient and physician notification of substitution.

The ACR has been lobbying for prior notification of a substitution, or if this is not feasible, notification "as immediately as possible."