3 September 2018 - The lives of more than 10 million Americans — those with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, ulcerative colitis and Crohn’s disease — depend on safe and effective biological medicines called tumour necrosis factor inhibitors.
These are highly effective but can cost as much $48,000 annually for a single patient.
Historically, biologics have enjoyed long market life because there was no approval pathway for biosimilars or follow-on biologics, that are copies of an originator biologic medicine. While not exactly generic copies, biosimilars have the potential to affect the market the same way: by introducing competition and driving down costs, while maintaining safety and efficacy. Congress created such a path in 2010, through the Biologics Price Competition and Innovation Act.