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biosimilar products FDA biosimilars COA

Addressing oncologists' gaps in the use of biosimilar products


Summary

The study highlights significant gaps in knowledge, competence, and confidence among oncologists regarding biosimilars. Educational interventions notably improved clinicians' understanding of the biosimilar approval process and familiarity with approved products. Post-education familiarity with the biosimilar process increased from 21% to 69%, and confidence in using biosimilars rose from 25% to 36%. Despite these improvements, confidence in integrating biosimilars into practice remains modest. Most participants did not view lack of evidence, patient reluctance, or formulary restrictions as major barriers. This suggests other obstacles, such as institutional or insurance issues, may impede biosimilar use. Further education is essential to boost provider confidence and encourage the adoption of biosimilars in clinical practice.

The availability of biosimilar products may improve access to healthcare by increasing the number of therapeutic options available at potentially lower costs. As of April 2019, 18 such biological products had been approved by the FDA, including 4 biosimilars for trastuzumab, 3 each for infliximab and adalimumab, 2 each for pegfilgrastim and filgrastim, and 1 each for rituximab, epoetin alfa, bevacizumab, and etanercept. The pace of approvals has accelerated, from the first indication for a filgrastim biosimilar in 2015 to 3 approvals in 2016, 5 in 2017, and 9 through early 2019, 7 of which were announced in the 2018 calendar year.

According to a current market forecast, global sales of biosimilars will exceed $19 billion by 2023, up from just $2.5 billion in 2017, driven by their cost-effectiveness and the patent expiration of a number of biologics. These products present substantial opportunities for cost savings, with one recent modeling analysis indicating an estimated 5-year US cost savings of $256 million for use of biosimilar filgrastims in patients with cancer requiring myelosuppressive chemotherapy...

 

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biosimilar products, FDA, biosimilars, COA