Europe Sees Its First Adalimumab Biosimilar Launches

Sandoz has announced that its biosimilar adalimumab, Hyrimoz, became available today in the United Kingdom.

Currently, an estimated 57,000 patients in England receive adalimumab, costing the National Health Service (NHS) approximately £500 million (approximately $658 million) per year. Sandoz says that adoption of its biosimilar could cut that cost in half.

Furthermore, Kavya Gopal, head of speciality at Sandoz, United Kingdom, said in a statement, “Now that doctors can prescribe Hyrimoz…the NHS has the opportunity to increase patient access to biologic treatments. As we’ve worked to launch Hyrimoz as the Humira patent expires, the NHS can start saving money from today.”

Sandoz also revealed that it has stockpiled extra supplies of the biosimilar to ensure that the NHS will have a steady supply of adalimumab in the case of a no-deal Brexit, which could delay the transport of medicines into and out of the United Kingdom.

Today’s launch follows Sandoz’s announcement on October 12 that it had reached a settlement with Humira’s sponsor, AbbVie, that terminated patent litigation over the drug. The terms of the deal allow Sandoz to launch the biosimilar in Europe today (the date of Humira’s European patent expiry), but if the drug is eventually approved in the United States, Sandoz will not be licensed to enter the US market until September 30, 2023.

The biosimilar, which will be Sandoz’s fifth biosimilar product to launch in the United Kingdom, is approved by the European Commission for all indications of the reference Humira on the basis of the phase 3 ADACCESS study in patients with moderate to severe plaque psoriasis.

Results of the study, which were presented at the American Academy of Dermatology Annual Meeting in March 2017, demonstrated that the biosimilar had similar efficacy to the reference Humira; after 16 weeks of treatment, 67% of patients receiving the biosimilar achieved a 75% improvement in their symptoms (as measured by the Psoriasis Area Severity Index) versus 65% of those treated with the reference product. The biosimilar’s safety profile was also similar to that of the reference.

Also launching today is Amgevita; biosimilar developer Amgen announced that it will begin selling its biosimilar adalimumab today in markets across Europe, though the drug maker did not specify which markets would receive access to the drug first.

"The launch of Amgevita in Europe is an important milestone for our biosimilars portfolio, expanding the range of treatment options for the millions of patients living with chronic inflammatory diseases," said David M. Reese, MD, executive vice president of research and development at Amgen, in a statement. "Amgevita is Amgen's second biosimilar to launch in Europe, demonstrating our commitment to providing patients with serious illnesses access to high-quality biological therapies."

Amgevita, also approved in the United States under a slightly different name (Amjevita), gained the European Commission’s authorization in 2017 on the basis of 2 phase 3 studies in patients moderate to severe plaque psoriasis and moderate to severe rheumatoid arthritis. Both studies met their primary endpoints with no clinically meaningful differences from the reference adalimumab. The drug will not launch in the United States until January 31, 2023, under the terms of a settlement between Amgen and AbbVie.