The biosimilars are highly similar to the reference biological medicinal products and provide an alternative for biologics. Many of the patents of biologics are near expiry and this may lead to increase in market share of biosimilars. The biosimilar market is expanding rapidly and although they are similar to their reference biologics in pharmacological activity, safety, and quality; they are cheaper in terms of cost. However, barriers exist for patients accessing these medicines. This chapter reviews the literature around those barriers and provides solution toward providing affordable access to biosimilars. The barriers related to accessing biosimilars include the time-consuming and complex development of biologics, stringent legislation, and registration process as well as healthcare professionals knowledge about biosimilars and litigation in the United States. There is a need to overcome those barriers and work toward producing uniform regulatory guidelines for the approval of biosimilars. The steps like these would certainly help to promote access and affordability of biosimilars for the masses.
|Title of host publication||Equitable Access to High-Cost Pharmaceuticals|
|Number of pages||14|
|Publication status||Published - 21 Feb 2018|