FDA defines that a biosimilar drug is a biologic product that is highly similar to an existing FDA-approved reference drug and has no clinically meaningful difference from the reference drug. It is considered interchangeable to the reference product.
Due to challenges held up by drug manufacture patents, United States has been slow in using biosimilar drugs. There are currently around 40 approved biosimilar drugs including those categorized as immunology, oncology, endocrinology, and ophthalmology drugs. Among all the therapeutical areas, inflammatory bowel disease, oncology, growth factor, and rheumatoid arthritis have the highest use of biosimilars. Rituximab, Infliximab, filgrastim, and pegfligrastim are the reference products having interchangeable biosimilars that are used most often in clinical settings.
Although there are some barriers to adopt biosimilars, it has seen an increase in implementing of biosimilars due to significant lower cost than the reference drugs. More and more biosimilars are expected to be used with coverage by payers, organization alignment, and physician and patient engagement.
Healthcare organizations are closely monitoring the financial opportunity and patient satisfaction when adopting biosimilars. Although formulary decisions made by the payer play a key role influencing prescribing, patient-centric performance is critical to implementing biosimilars.
We will introduce current most often used biosimilar drugs in our future blogs and how patients can benefit from using those biosimilars compared to the reference products.
Biosimilar drugs information sourced from ashp.org