No safety or immunogenicity differences were found in patients who switched to a biosimilar and those who continued on a reference biologic or biosimilar.
No difference was found in the safety profiles or immunogenicity rates in patients who were switched and those who stayed on a reference biologic or biosimilar, according to the first systematic review using statistical methods to address switching risk in patients between reference biologics and biosimilars in PLoS One.
Biosimilars are progressively available for the treatment of multiple severe disorders, but some concerns remain about switching a patient to a biosimilar whose condition is stable on the reference biologic.
Researchers analyzed the occurrence of safety events after a switch to or from a biosimilar and its reference biologic in all identified controlled clinical studies that encompassed a biosimilar approved by the FDA.
Growing the availability and use of biosimilars is an important public health strategy for decreasing drug costs and increasing the accessibility of biological products to underserved populations.
Randomized controlled studies and extension studies with a switch treatment period (STP) to or from a biosimilar and its reference biologic were distinguished from publicly available information sustained by the FDA. These findings were strengthened with data from peer reviewed publications that held information not captured in FDA reviews. A total of 44 STPs were recognized from 31 distinctive studies for 21 different biosimilars.
PRISMA guidelines to extract and synthesize the data were followed. Meta-analysis was undertaken to estimate the overall risk difference across studies. Patients who were switched to or from a biosimilar and its reference biologic make up a cohort of 5,252 patients.
Additionally, deaths, serious adverse events, and treatment discontinuation included in safety data illustrated an overall risk difference of -0.00, 0.00, -0.00 across STPs, respectively. Similar incidence of antidrug antibodies and neutralizing antibodies in patients within a STP who were switched to or from a biosimilar to its reference biologic and patients who were not switched were displayed by immunogenicity data. Also, immune-related adverse events like anaphylaxis, hypersensitivity reactions, and injection site reactions were similar in switched and non-switched patients.
Antidrug antibodies and neutralizing bodies showed comparable incidence between No Switch and Switch arms. The study participants in the STPs are symbolic of patients who would be switched to or from a biosimilar and its reference product and mirror actual use. This outcome is constant with empiric evidence and descriptive reviews of switching biosimilars and referencing biologics.
“The findings in this report raise several timely questions regarding the data needed to support approval of biosimilars and how to address regulatory requirements unique to the [Biologics Price Competition and Innovation Act] for the 'interchangeable' designation,” said the researchers.
Interchangeability designations allow for pharmacists to substitute a reference product for a biosimilar without needing to obtain permission from a provider. It's intended to increase access to biosimilars and shorten wait times for patients to get their prescriptions. However, many experts question whether designations like this should be needed.
Also, the findings supported efforts to decrease the regulatory burden of switching studies as the default approach for acknowledging the switching standard for the interchangeable designation.
This study also supports the reassessment of the need for switches included in clinical studies for candidate biosimilars since an approved biosimilar will be analytically highly similar to its reference product. As familiarity and the support for biosimilar approvals grows, the amount and types of clinical data consistently performed as part of biosimilar development may be decreased, which would also decrease the time and cost of development.
Some limitations were present in this review, including the small number of patients in the safety evaluations from some source material. There were fewer patients in some STPs, but these differences in STP sample size had been taken into consideration in the meta-analysis.
This study acknowledges one of the concerns of the medical community about the safety of switching between reference products and corresponding biosimilar products.
“Data driven materials such as those contained in this report will facilitate efforts to streamline biosimilar development and achieve the full promise of biosimilars,” concluded the researchers.
Reference
Herndon TM, Ausin C, Brahme NN, et al. Safety outcomes when switching between biosimilars and reference biologics: a systematic review and meta-analysis. PLoS One. Published online October 3, 2023. doi:10.1371/journal.pone.0292231
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability
April 30th 2024During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.