Now that multiple biosimilars of adalimumab (Humira) are approved, though none have launched in the United States or European Union, attention is turning toward the next wave of biosimilar candidates.
Click to read more about the biosimilar pipeline.
Writing in Current Rheumatology Reports, Sizheng Zhao, MBChB, of Aintree University Hospital in Liverpool, United Kingdom, and colleagues report that, in addition to Amgen’s Amjevita/Amgevita, Boehringer Ingelheim’s Cyltezo, and Samsung Bioepis’ Imraldi, an additional 10 adalimumab biosimilars are in phase 3 development:
- Fujifilm Kyowa Kirin has completed a phase 3 trial for FKB327. The randomized study enrolled 728 patients with rheumatoid arthritis (RA), and completed in July 2016.
- Pfizer has completed a phase 3 trial for PF-06410293 in patients with RA. The study in 597 patients with RA included an optional, open-label component in which a subset of patients used a prefilled pen device to administer 3 injections of the biosimilar at home. The study was completed in December 2017.
- Coherus has completed a phase 3 trial of CHS-1420 in 545 patients with chronic plaque psoriasis. The study involved a switch from the reference to the biosimilar. The study was completed in March 2017.
- Momenta has completed a phase 3 study of M923/BAX923 in 572 patients with chronic plaque psoriasis. The study was completed in April 2017.
- Mylan has completed a phase 3 study of MYL-1401A in 294 patients with chronic plaque psoriasis. The study was completed in March 2017.
- LG Life Sciences is engaged in an ongoing phase 3 study of LBAL in 380 patients with RA.
- Merck is underway with a phase 3 trial of MSB11022 in 288 patients with RA.
- Sandoz is engaged in a European-registered phase 3 trial of GP2017 in patients with RA. Trial protocols have been completed in 5 countries where the trial is taking place, but have not yet been completed in the United Kingdom.
- Biocad is undertaking a phase 3 trial of BCD-057 in 344 patients with plaque psoriasis. The study involves a transition from the reference Humira to the proposed biosimilar.
- Oncobiologics is underway with a European-registered phase 3 trial of ONS-3010 in patients with plaque psoriasis.
On a global level, 3 more adalimumab biosimilars have been approved in other regulatory territories: CinnoRA (approved in Iran), Exemptia, and Adfar (both approved in India).
“The year 2018 will see several biosimilars of adalimumab emerge in clinical practices worldwide,” write the authors, adding that “These adalimumab biosimilars, and many more in the pipeline, will offer exciting opportunities in improving treatment access and increasing treatment options worldwide.”
Zhao S, Chadwick L, Mysler E, Moots RJ. Review of biosimilar trials and data on adalimumab in rheumatoid arthritis. Curr Rheumatol Rep. 2018;20(10):57. doi: 10.1007/s11926-018-0769-6.