New Developments Propel Biosimilar Penetration of US Oncology Market

The biosimilars realm of oncology has been surrounded by a burst of clinical and regulatory news this week, with the read out of phase III findings and extension data, legality issues, and more.

Take a look at the updates with biosimilars in oncology over the last several days.

Trastuzumab Biosimilar Efficacy Sustained With Updated Data

Adjuvant treatment with the trastuzumab (Herceptin) biosimilar CT-P6(Herzuma; trastuzumab-pkrb) demonstrated comparable efficacy and safety to the reference product in patients with HER2-positive early breast cancer, according to results of posthoc analyses of a phase III trial (NCT02162667).¹

The biosimilar was approved by the FDA in December 2018 for the treatment of patients with HER2-overexpressing breast cancer. The approval was based on an extensive review of a comprehensive data package, which included foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety findings.²

Prior data from the double-blind, parallel group, active-controlled phase III study showed that the biosimilar demonstrated equivalent efficacy to reference trastuzumab in the neoadjuvant setting.³

Rituximab Biosimilar Is Equivalent to Reference Product in CD20+ Non-Hodgkin Lymphoma

ABP 798, a rituximab (Rituxan) biosimilar, demonstrated clinical equivalency to reference rituximab in patients with CD20-positive B-cell non-Hodgkin lymphoma, according to topline results of the comparative phase III JASMINE study (NCT02747043).⁴

The primary endpoint, which was an assessment of objective response rate at week 28, was within the prespecified margin for ABP 798 compared with rituximab. The safety and immunogenicity data with ABP 798 were similar to the reference product as well. Earlier data showed that ABP 798 was similar to reference rituximab sourced both from the United States and the European Union in relation to biological activity across a number of assays.⁵

Motion to Halt Sales of Bevacizumab Biosimilar Denied

A panel of judges for the US Court of Appeals for the Federal Circuit denied motion filed by Genentech for an injunction that would have blocked Amgen from selling its bevacizumab (Avastin) biosimilar Mvasi (bevacizumab-awwb), pending the outcome of an appeal.⁶

Following the September 2017 FDA approval of the biosimilar, Amgen sent Genentech, the company manufacturing reference bevacizumab, its notice of commercial marketing and that it would not launch the biosimilar <180 days from the letter. Following the letter, Amgen filed a number of supplements to its biologics license application with the agency, which did include updates to the biosimilar’s label. Since Amgen filed these, Genentech reported that the FDA-approved biosimilar following the supplements was different than what was initially approved and sought an order to prohibit Amgen from marketing Mvasi until 180 days after a new commercial marketing notice was filed.

After the court disagreed with Genentech, the company then sought an injunction on Mvasi sales pending an appeal of that decision.

Amgen's Anticancer Biosimilars Get UnitedHealthcare Nod

UnitedHealthcare has stated that Amgen’s biosimilars—the bevacizumab biosimilar Mvasi and a trastuzumab biosimilar (Kanjinti)&mdash;will be preferred products for commercial, community, and Medicare Advantage plans, effective October 1, 2019.⁷ Reference bevacizumab and trastuzumab will no longer be preferred products.

Other biosimilars that are not yet launched in the United States, will not be preferred oncology products.

References

1. Esteva FJ, Baranau YV, Baryash V, et al. Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial [published online ahead of print August 19, 2019]. Cancer Chemo and Pharma. doi: 10.1007/s00280-019-03920-4.
2. Celltrion and Teva announce FDA approval of Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin, for the treatment of HER2-overexpressing breast cancer for certain indications [news release]. Incheon, South Korea, and Jerusalem, Israel: Celltrion. Published December 14, 2018. https://bit.ly/2KY6s8i. Accessed December 17, 2018.
3. Esteva FJ, Lee S, Yu S, et al. 24 months results from a double-blind, randomized phase III trial comparing the efficacy and safety of neoadjuvant then adjuvant trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer (EBC). Lancet Oncol. 2017;18(7):917-928. doi: 10.1016/S1470-2045(17)30434-5.
4. Amgen And Allergan Announce Positive Top-Line Results From Comparative Clinical Study Of ABP 798, Biosimilar Candidate To Rituxan® (Rituximab). Amgen. Published August 22, 2019. https://bit.ly/2L0pACF. Accessed August 22, 2019.
5. McBride H, Maher G, Sweet H, Foltz I, Kuhns S. Functional similarity of proposed biosimilar ABP 798 with rituximab. Blood. 2017;130:5001. bloodjournal.org/content/130/Suppl_1/5001.
6. United States Court of Appeals for the Federal Circuit. Genentech, Inc., Plaintiff-Appellant City of Hope, Plaintiff v. Immunex Rhode Island Corporation, Amgen Inc., Defendants-Appellees. Published August 16, 2019. https://bit.ly/2zh99wo. Accessed August 22, 2019.
7. UnitedHealthcare. Network bulletin. Published August 2019. https://bit.ly/2KQCZhO. Accessed August 22, 2019.