Generic biologic drugs as effective as originals: study

Generic biologic drugs are similarly effective to brand-name counterparts in treating rheumatoid arthritis, inflammatory bowel disease and psoriasis, according to a new study.

Biologics, which are medications derived from living cells are complicated to manufacture and companies that make brand-name versions said  cheaper generic versions were not interchangeable with their products.

The patents of many brand-name biologics were expiring and according to researchers from the Johns Hopkins University, the use of generic versions (called biosimilars) could save patients and the healthcare system significant amounts of money.

"The billion-dollar question has been whether these 'generic biologics' are the same as the brand-name versions," study leader Dr G Caleb Alexander, associate professor in the department of Epidemiology at the Bloomberg School of Public Health, and co-director of the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, said in a university news release.

"The same debate occurred with the advent of less complicated generic drugs and now it's being hashed out all over again with much more at stake - more room for error and more potential for cost savings to the health system," he explained.

"But based on the available evidence, we conclude that the products we studied appear comparable, and they will definitely be cheaper," Alexander said.

Alexander and colleagues analysed 19 studies to compare biosimilars and reference tumor-necrosis factor-alpha (TNF-alpha) inhibitors used in the treatment of rheumatoid arthritis, inflammatory bowel disease and psoriasis.

Overall, eight studies were phase 1 randomised trials, five studies were phase 3 randomised trials while six studies were observational, the researchers said.

The researchers found that the prespecified equivalence margin of 80 per cent to 125 per cent was met by the pharmacokinetic parameters of the biosimilar and respective biologic in all phase 1 trials.

They further noted that clinical responses and adverse events were similar between the treatments in phase 3 trials, with adverse events usually of mild to moderate severity. The results pointed to cross-reactivity between products in two cross-sectional observational studies.