Biosimilar Rheumatology Roundup: August 2020

August proved to be a big month for biosimilars used to treat patients with rheumatic diseases. Several products were launched around the world, and there were important clinical trial developments. The following is a summary of this news.

Biosimilar Launches for Rheumatoid Arthritis

In Canada, Sandoz launched 2 biosimilars. Its rituximab molecule (Riximyo) is a monoclonal antibody used to treat rheumatoid arthritis (RA), non-Hodgkin lymphoma, and chronic lymphocytic leukemia. The other biosimilar was a pegfilgrastim (Ziextenzo), used to decrease the risks of infection associated with febrile neutropenia in chemotherapy treatment.

Later in the month, British Columbia moved forward with the third phase of its mandatory biosimilar switching program. Patients enrolled in the pharmaCare prescription plan receiving reference rituximab (Rituxan) would be switched to 1 of 3 biosimilar versions available, including Truxima, Riximyo, and Ruxience, according to the plan.

The current program phase will affect patients undergoing treatment for granulomatosis with polyangiitis, microscopic polyangiitis, relapsing-remitting multiple sclerosis, and RA.

Over in Germany, Mylan and Lupin Limited launched their etanercept biosimilar (Nepexto) as part of a commercialization agreement signed in 2018.

The launch comes after Nepexto was approved by the European Commission in May for all indications of the reference product (Enbrel), including RA, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and chronic severe plaque psoriasis.

Cadila Pharmaceuticals launched its adalimumab biosimilar Cadalimab on the Indian market, marking the company’s fourth product launch since July. Cadila noted that the adalimumab market in India is large: Roughly 7 million individuals have RA, and 2.8% of the population have psoriasis.

Osteoporosis News

In addition, Cadila launched its teriparatide molecule (NuPTH) in India. This drug references Eli Lilly’s Forteo for the treatment of patients with osteoporosis or an increased risk of fracture. Cadila said that India is considered the “osteoporosis capital of the world” because an estimated 26 million individuals have this condition.

Celltrion Healthcare is working to bring a treatment for osteoporosis to market. In September, the company will start a phase 1 clinical trial for a denosumab biosimilar (CT-P41). CT-P41 references Amgen’s Prolia and inhibits the bone resorption process by binding with the cytokine receptor activator of nuclear factor kappa-Β ligand (RANKL). This blocks the development of osteoclasts, which break down bone tissue. Celltrion said it plans to begin phase 3 trials in the first half of 2021 and commercialize the product in 2025 once patents expire for Prolia.

Additionally, Celltrion has partnered with Intract Pharma to produce the world’s first oral infliximab formulation for the treatment of inflammatory bowel disease.

Notable Study Findings

A study from Iran demonstrated the effectiveness of a CinnaGen’s interferon beta-1a biosimilar (ReciGen) in helping to reduce symptoms and achieve virological clearance in patients hospitalized with coronavirus disease 2019 (COVID-19).

ReciGen was tested in combination with Iran’s conventional COVID-19 therapy including hydroxychloroquine and lopinavir/ritonavir and helped resolve COVID-related fever after 8 days in all 20 patients included in the study.

Lastly, investigators doing a year-long real-world study on anti—tumor necrosis factor (TNF) originator biologics and biosimilars for Crohn disease (CD) and ulcerative colitis (UC) found anti-TNF therapy to be more effective for achieving remission in patients with CD compared with those with UC.

The investigators concluded that their study advanced understanding of anti-TNF agents in inflammatory bowel disease and recommended that large prospective studies and randomized controlled trials be done to compare use of biologics in UC versus CD.