Biosimilars Regulation in the United States and FDA Approved Biosimilars from 2015-2018

(E-pub Ahead of Print)

Author(s): Vikram Saini, Aakash Deep*, Manita Jindoliya, A C Rana, Monu Yadav, Rakesh Kumar Marwaha.

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

Become EABM
Become Reviewer


Background: Biological products are the chemicals in the form of medicines that are prepared from the living cells through highly intricate manufacturing techniques that should be handled and managed under favorable conditions. The regulation of the biosimilar products consist of significant challenges, since they are part of growing sector of the pharmaceutical industry and normally used by human beings. The regulatory framework and the technical requirements of the US biosimilars program involve a stepwise approach that relies heavily on analytical methods to demonstrate through a “totality of the evidence” that a proposed product is biosimilar to its reference product. By integrating analytical, pharmacological, and clinical data, each of which has limitations, a high level of confidence can be reached regarding clinical performance. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of health reform (Affordable Care Act).

Objective: The current manuscript will provide the information regarding the regulation of Biosimilars products with the detail of biosimilar USER fees structure and the list of approved biosimilar by FDA from 2015- 2018.

Conclusion: Research is continually developing the more and more biological products that will help to treat medical conditions or add some innovative to the existing treatment options. Biosimilars and reference products are generated in the living cells and require trained expertise’s as well as technology in manufacturing biologics are usually highly effective compared to small molecule drugs. These are usually specific against the respective target, which generally produce lesser side effects and low toxicity. FDA’s regulatory authority for the approval of biologics is under PHS (public Health Service Act however that are also suggested to regulate under the Federal Food, Drug, and cosmetics Act (FD&C). Biosimilars can help expand access to high quality treatment options for doctors and patients, as well as reduce costs for the healthcare system.

Keywords: Biosimilars, Regulation, FDA approved biosimilar products

Rights & PermissionsPrintExport Cite as

Article Details

(E-pub Ahead of Print)
DOI: 10.2174/2213476X06666190213141839

Article Metrics

PDF: 1