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Alan Stolier, MD/

“Biosimilars” OK for Your Patients: Same Effectiveness. Lower Cost.

Trastuzumab Biosimilar ABP 980 Study Demonstrated Clinical Non-Inferiority

Biosimilars are biologic products that are highly similar but have no clinically meaningful differences from an FDA approved reference product.  More and more biosimilars will be on the market as current drugs patents expire, allowing for significantly lower pricing than patented products.

The need for biosimilars

Ogivri (Mylan, GmbH) was the first biosimilar (similar to trastuzumab/Herceptin)  for breast cancer therapy cleared by the FDA in December 1, 2017.  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm

And now a newer Herceptin biosimilar from Amgen is right around the corner.  The patents on Herceptin, used to treat HER2-positive (HER2+) metastatic breast cancer and HER2+ early breast cancer will expire in the US in June 2019.

In In a recent publication in The Lancet, published online in June 2018, a newer biosimilar, ABP 980 (Amgen Inc., Thousand Oaks, CA, USA) was compared to trastuzumab in Her2 positive patients undergoing neoadjuvant chemotherapy. The study took place in 20 countries, mainly in Europe and South America. All patients had 4 initial cycles of an anthracycline followed by weekly paclitaxel plus trastuzumab or ABP 980. All patients then stayed on one of the monoclonal antibodies given every 3 weeks for a year. During the post-chemotherapy year, some patients had their drug switched in order to evaluate safety and immunogenicity. Of the 827 enrolled, 696 patients were evaluable. APB 980 was associated with a pCR of 48% compared to 42% for trastuzumab. There was no statistical difference. Overall there was no difference in safety or clinical outcomes.

Dr. Christi stated, “ABP 980 (Amgen Inc,) is a biosimilar of trastuzumab, with analytical,

functional, and pharmacokinetic similarities. We compared the clinical safety and efficacy of ABP 980 with that of trastuzumab in women with HER2-positive early breast cancer and found that there are no clinically meaningful differences between ABP 980 and trastuzumab. Our findings add to the growing body of evidence supporting the potential clinical usefulness of ABP 980. Additionally, switching from trastuzumab to a biosimilar seems to be safe. The use of trastuzumab biosimilars could mitigate cost barriers for payers, and increase patients’ access to important therapy.”

The reason biosimilars cost less to produce is not only because of the manufacturing process but also the much simpler path for FDA clearance. It is difficult and costly to recreate biologics because the complex proteins are derived from living organisms that are genetically modified. In contrast, small molecule drugs made up of a chemically based compound can be easily replicated and are considerably less expensive to reproduce. In order to be released to the public, biosimilars must be shown to be as close to identical to the parent innovator biologic product based on data compiled through clinical, animal, analytical studies and conformational status.

NOTE:  The FDA has in fact concluded that an approved biosimilar may be substituted for the reference product without consulting the prescriber….no worries, it’s all good!

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