Biosimilar Rheumatology Roundup: October 2018

With the launch of some of the most highly anticipated products thus far in the biosimilar experience, and with the release of key new data on multiple biosimilar products, October 2018 was a memorable month for biosimilar stakeholders.

Undoubtedly, the biggest news in biosimilars this October was the launch of 4 biosimilar adalimumab products in the European Union following the patent expiry of AbbVie’s Humira.

The first products to announce launches were Sandoz’s Hyrimoz, which became available in the United Kingdom (and which is being stockpiled for use in the National Health Service [NHS] case of a no-deal Brexit), and Amgen’s Amgevita, which became available in multiple EU markets. Next to announce a launch was Samsung Bioepis’ Imraldi, followed by Mylan’s Hulio, both of which also launched in multiple countries.

Another 2 products could be added to the mix next year; the United Kingdom’s final briefing on adalimumab revealed that the NHS expects Boehringer Ingelheim’s Cyltezo to enter the market in 2019 and noted that Fresenius Kabi’s product could also launch in the coming year. In preparation to use the best-value adalimumab once the tendering process is complete, the NHS has also released patient-ready educational materials to help ready patients to make the switch.

Biosimilar adalimumab also got a boost from data presented at this month’s American College of Rheumatology (ACR) Annual Meeting, held in Chicago, Illinois, October 19-24, 2018. At the meeting, researchers presented data from the VOLTAIRE-RAext study of Cyltezo. The 3-arm study compared patients who took the biosimilar continuously, who switched from Humira to the biosimilar, or who took Humira continuously. No new safety or immunogenicity concerns were found in the study.

A phase 3 study of Innovent Biologics’ IBI303 in patients with ankylosing spondylitis (AS) found that the proposed product had similar efficacy, safety and immunogenicity to the reference, and an observational trial of Zydus Cadila’s Exemptia in patients with AS found that a quick, clinically significant, and sustained clinical benefit from 12 weeks of treatment with the biosimilar.

Despite so much progress for biosimilar adalimumab, however, novel drugs may be poised to outperform the top-selling Humira. AbbVie’s upadacitinib demonstrated superiority to adalimumab in the phase 3 SELECT-COMPARE trial in patient with rheumatoid arthritis (RA), and Novartis’ Cosentyx (secukinumab) has expanded its label in Europe to include doses of up to 300 mg for the treatment of psoriatic arthritis.

Etanercept, which still awaits a biosimilar launch in the United States, also benefitted from positive data presented at the ACR meeting. Researchers reported that Samsung Bioepis’ Benepali was subject to higher retention rates than the reference Enbrel among patients with RA. Another study found that a majority of patients who switched to Benepali in a UK center had a good response. Finally, a study of Sandoz’s biosimilar etanercept candidate, GP2015, found comparable safety and efficacy between the biosimilar and the reference.

Further investigations of switching presented at ACR found that European nonmedical switches to biosimilars did not affect efficacy or safety of treatment and also did not impact patients’ satisfaction with their treatment. However, healthcare utilization costs were found, in a separate UK study, to increase with nonmedical switches.

Meanwhile, in the US context, where patients still await access to the cost-saving biosimilars available in the European Union, the Trump administration has unveiled a plan that it hopes will reduce Medicare’s costs for prescription drugs. Under the plan, Part B drugs, including biologics, could see their prices brought in line with those paid in other nations using what HHS has termed an International Price Index. In announcing the proposal, Trump said that “We are taking aim at the global freeloading that forces American consumers to subsidize lower prices in foreign countries through higher prices in our country.”

Stakeholder response to the proposal was mixed, with ACR noting that such an approach could limit treatment options for American patients, and the Biosimilars Forum saying that the tactic could have a positive impact on the biosimilar industry.

The administration also signaled this month that it will move forward with its plan to require drug makers to disclose the list prices of their drugs in direct-to-consumer advertising, indicating that, in HHS’ view, the Pharmaceutical Research and Manufacturers of America’s proposal to provide web links to pricing information in advertising did not go far enough.

Other attempts to address the skyrocketing cost of biologic drugs have made headlines in the United States this month; public employees in the state of Utah, The Salt Lake Tribune reported, are being paid to travel to Mexico to fill prescriptions for drugs including Humira and Enbrel. The employees’ health plan covers the costs for patients to fly to San Diego, California, as well as costs to drive them across the border to pick up their prescriptions in Tijuana, Mexico, as a cost-saving measure.