Biosimilars, nearly identical copies or “generic” versions of biologic drugs, are predicted to reach a global market share of close to $24 billion by 2023, up from less than $6 billion in 2018, according to a report by ResearchAndMarkets,com.
Drivers of the market surge include cost-effectiveness. In identifying an impediment to growth, the report cites the still-stringent federal regulatory requirements which inhibit investment in the new drugs.
Decreasing Costs, Increasing Access
Richard Dolinar, M.D., a senior fellow for health care policy at The Heartland Institute, which publishes Health Care News, says the U.S. Food and Drug Administration’s (FDA) approval process for biosimilars is excessively rigorous, as quoted in the February 2018 issue of Budget & Tax News (BTN), published by The Heartland Institute. Streamlining the approval process for biosimilars would increase access to needed treatments and cut costs, Dolinar says.
“I think [biosimilars] will add competition to the marketplace,” Dolinar told BTN. “Whenever you have competition, prices come down. I think they’ll be beneficial in increasing patients’ access to expensive medications at a cheaper rate.”
In a 2014 scientific journal article on biosimilar insulins, “Impact of Biosimilar Insulins on Clinical Practice,” Dolinar and his coauthors found in spite of “complexities associated with establishing safety and efficacy guidelines,” an accompanying survey showed “significant enthusiasm for biosimilars” despite “a general lack of knowledge and misunderstandings about biosimilars within the health care community,” Dolinar wrote.
Working with FDA
Daniel Seaton, director of health communications at the Biotechnology Industry Organization (BIO), say biotech companies have worked with the FDA to develop an approval regime that will encourage innovation and competition.
“BIO and its member companies helped establish a pathway for the approval of biosimilars in the United States because of their potential to increase competition and provide greater choice for patients and physicians,” Seaton said. “Many of our member companies are developing or have received approval for biosimilar medicines. BIO believes that robust competition at each stage of the biopharmaceutical lifecycle, including competition among branded drugs in the same class and from generic drugs and biosimilars, is the best mechanism to control costs for patients and payers while encouraging the continued investment in innovation required to bring new treatments and cures to patients over time.”
Calls for Federal, State Reforms
Seaton says his company is dedicated to helping create a thriving biosimilar market and expressed a commitment on the part of BIO to continue advocating policies that increase competition and spur innovation to expand the use of biosimilars in the U.S. market.
“As part of our commitment to creating a robust marketplace for biosimilars, we have been continuously engaged with the FDA’s efforts to implement provisions of the Biologics Price Competition and Innovation Act (BPCIA),” Seaton said, referring to a 2009 federal law designed “to create an abbreviated approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to or ‘interchangeable’ with an FDA-approved biological product,” according to the FDA.
“We have also long advocated for state legislation to allow for the substitution of interchangeable biologics at the pharmacy level,” Seaton said.
“Biosimilars: $23.63 Billion Global Market Outlook to 2023—Growth Opportunities in Emerging Markets—ResearchAndMarkets.com,” Business Wire, July 6, 2018: https://www.businesswire.com/news/home/20180706005079/en/Biosimilars-23.63-Billion-Global-Market-Outlook-2023
Dr. Richard Dolinar et al., “Impact of Biosimilar Insulin of Clinical Practice,” Journal of Diabetes Science & Technology, January 1, 2014: http://journals.sagepub.com/doi/full/10.1177/1932296813518267