With more biosimilars poised to enter the market, stakeholders seek to ensure safety and efficacy.
Patients for Biologics Safety & Access (PBSA), a national coalition comprised of 20 advocacy groups, recently urged Congress to address concerns regarding the use of biosimilars, according to a press release.
There have been 9 biosimilars approved in the United States, 5 of which gained approval in 2017. In light of the increase in approvals last year, advocacy groups felt it was crucial for Congress to hold oversight hearings related to biosimilar development to ensure patient safety and access, according to the release.
The PBSA is specifically calling on the Senate Committee on Health, Education, Labor, and Pensions, as well as the House Committee on Energy and Commerce, to address the issue.
As the FDA continues to approve more biosimilars, advocacy groups want to ensure that the drugs are safe and that patients will have continued access to treatment. The safety and efficacy of biosimilars are necessary for patients who rely on them, which prompted the PBSA to get involved, according to the release.
“Millions of Americans who rely on biologics and biosimilars to manage their health depend on the safety and effectiveness of these drugs to live a healthy, stable life,” said Larry LaMotte, vice president of Public Policy at the Immune Deficiency Foundation and lead coordinator of PBSA. “As more biosimilars come to market, it is critical that Congress ensure that the FDA is prioritizing patient safety through its guidance, approvals, education and post-market surveillance.”
One concern raised by the organization is that insurance companies will switch patients to biosimilars that are not interchangeable, arguing this change can be harmful to patients. According to PBSA, additional steps need to be taken to prevent this from occurring.
Patients also want reassurance that approved biosimilars, biologics, and interchangeable products are evaluated for adverse effects. Post-marketing surveillance should be utilized to determine whether a product continues to be safe in real-world use, according to the release.
Lastly, the PBSA wants both patients and health care providers to be informed on new information regarding biosimilars, including the Biologics Price Competition and Innovations Act, and the introduction of new biosimilars to the market.
In 2017, Congress held hearings to reauthorize the Biosimilar User Act Fee, although there have not been any oversight hearings since 2016, according to the release.
“PBSA is already working with the FDA to provide feedback on their biosimilar education initiatives and looks forward to continuing to work with them to ensure the patient voice is front-and-center in future efforts to educate Americans about the efficacy and reliability of biosimilars,” LaMotte said.