In 2019, there were 10 new biosimilar products approved by the FDA, which followed seven approvals in 2018, five in 2017, three in 2016, and the inaugural approved biosimilar in 2015.
The biosimilars approved last year include treatments for rheumatoid arthritis, plaque psoriasis, breast cancer, metastatic stomach cancer, metastatic colorectal cancer, nonsquamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
The biosimilar approvals “will further help to create competition, increase patient access, and potentially reduce the cost of important biological drug therapies,” the FDA said.
While the numbers have gone up each year, many in the healthcare industry believe it’s still slow, and as of May 1, there have been no new biosimilar products approved for 2020—though the COVID-19 pandemic obviously has played a role there.
Patti Seymour, MBA, CSCP, managing director in BDO’s BioProcess Technology Group, explains clear regulatory and intellectual property (IP) guidance are both key to providing a well-defined path to approval of biosimilar products in the U.S., or anywhere.
“This allows product developers to more accurately estimate their costs and reduce the uncertainty associated with development of these products,” she says. “Both the FDA and the European Medicines Agency (EMA) have done a good job providing clear regulatory guidance for biosimilars, and both have traditionally been willing to meet with developers to provide feedback on plans.”
Conversely, the IP landscape and process for issue resolution for biosimilars is far less clear than it is for generic small molecule therapeutics. Manufacturers often put many patents on biologic. Seymour notes this increases uncertainty and perceived risk and ultimately reduces the number of groups willing to invest in biosimilar development in the U.S.
“Finally, obtaining innovator product samples to use as a comparator while developing biosimilars can be challenging and is another obstacle to biosimilar development,” she says.