Reference bevacizumab and proposed biosimilar (BAT1706) demonstrate high similarity to each other.
A study showed that a proposed biosimilar of bevacizumab (BAT1706) comparably matches with reference bevacizumab (EU/US-sourced Avastin) in terms of physiochemical and functional qualities reviewed, according to Drugs in R&D.
A thorough physicochemical and functional similarity study is a necessary part of showing biosimilarity between a reference biologic and a proposed biosimilar and was carried out for BAR1706 and reference bevacizumab.
Reference bevacizumab is a vascular endothelial growth factor (VEGF)- targeting biologic used to treat multiple cancers, including metastatic colorectal cancer.
Study authors reported on the physiochemical and functional similarity of BAT1706 and reference bevacizumab obtained from the United States (US-bevacizumab) and the European Union (EU-bevacizumab).
First, a wide range of product qualities, including primary and higher order structure, post-translational modifications, purity, stability, and potency, were characterized for BAT1706 and EU/US-sourced reference bevacizumab using sensitive state-of-the art analytical methods. Up to 18 lots of US-bevacizumab and 29 lots of EU-bevacizumab, and 10 unique drug substance lots of BAT1706 were evaluated.
BAT1706 presented an identical amino acid sequence and an indistinguishable higher-order structure compared with EU/US-sourced reference bevacizumab. BAT1706 and EU/US-bevacizumab also showed similar post-translational modifications, glycan profiles, and change variants. Potency was evaluated through a large range of bioassays and also displayed comparably between BAT1706 and EU/US-bevacizumab, with statistical equivalence showed for VEGF-A binding and neutralizing activity.
A risked-based tier approach was used for all attributes and offers a systematic way to review analytical similarity with a high confidence level and low potential for bias.
“Greater than 90% of the measured biological activities of all BAT1706 lots fall within the range of the quality range of EU/US-bevacizumab (mean 3 AU),” said the study authors.
These results strongly back the deduction that BAT1706 shows highly similar functional properties compared with reference bevacizumab.
Furthermore, quality range and visual comparison analyses showed that BAT1706 and reference bevacizumab have identical primary structures and indistinguishable higher-order structures, and highly similar purity profiles and charge isoforms.
Small differences in the ratio of galactosylation and afucosylation were found, but not expected to affect clinical safety and efficacy.
Additionally, the stability of BAT1706 and EU/US-bevacizumab was reviewed in a series of degradation experiments. The degradation pathways and degradation rates were shown to be similar for BAT1706 and the reference bevacizumab under all conditions measured.
“In conclusion, the current demonstrated and positive regulatory biosimilarity review, regardless the minor differences were observed, but these differences were not clinical meaningful, therefore it can be concluded that overall product quality of BAT1706 can be considered highly similar to EU/US Bevacizumab,” said the study authors.
Reference
Cao D, Deng C, Wang G, et al. Physicochemical and functional similarity assessment between proposed bevacizumab biosimilar BAT1706 and reference bevacizumab Drugs R D. Published online June 26, 2023. Accessed July 26, 2023. doi:10.1007/s40268-023-00432-8
Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars
May 15th 2024At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.
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.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.