Biosimilars are emerging class of medications that are very similar to biologicals in terms of safety and efficacy to the original reference product, but not the same as generic, originating, or reference drugs. Biosimilars have delivered on their promise to reduce costs, increase access and improve patient lives. As efforts continue to streamline development even further, the need for technology that can efficiently assess biosimilarity early in the pipeline is more critical than ever. Notably, healthcare professionals still have a somewhat negative or reluctant connotation regarding biosimilars despite increased patient choice and the potential cost-savings compared to originator biologicals. There remain further challenges and opportunities for increasing the use of biosimilars among practices and payers.

While biosimilars, which are highly similar copies of existing biologicals, have increased affordability compared to biologicals due to their abbreviated approval process, there remains a need for more cost-effective and efficient methods to develop these drugs, given their complexity and increasing demand. Tools enabling efficient biosimilar characterization early in the pipeline are becoming increasingly important for devising the next generation of therapeutics.

Breast cancer, with a staggering number of cases recently, has become the most common cancer among females. Human epidermal growth factor receptor-2 (HER2)-positive breast cancer involves the cell-surface protein receptor that promotes cell growth and proliferation. This type of cancer is more aggressive than typical breast cancer and represents a promising therapeutic target due to its anti-tumour effects. The National Comprehensive Cancer Network (NCCN) clinical practice guidelines recommend the use of docetaxel and carboplatin in combination with trastuzumab (± pertuzumab) for advanced-stage breast cancer patients. The emergence of trastuzumab, the first oncogene-targeted therapeutic agent for solid tumours clinically available under the brand name Herceptin, has significantly improved the treatment options for patients with this type of breast cancer. However, the associated cost remains to be a significant barrier for breast cancer patients to access this treatment.

The Sarder and Ahmad review includes biosimilars that have already been approved by global regulatory agencies and are available in the marketplace. It also covers those currently undergoing assessment in preclinical studies and clinical trials, with emphasis on their chemistry and potential future treatments for patients with breast cancer.

The finding from this review article suggests that these biosimilars, by-and-large, have the same safety and efficacy profiles, as well as similar pharmacodynamic and pharmacokinetic features, with trastuzumab. Trastuzumab has been in use for over quarter of a century for HER2-positive patients with breast cancer. As the biosimilar market continues to grow, more patients will have access to these treatment options, potentially saving thousands of more lives worldwide annually.

The authors concluded that, given the adoption of biosimilars by international medicines agencies, particularly the US and European Union drug administrators, it is hoped that healthcare professionals, particularly in the field of oncology landscape, will significantly reduce their fear and reluctance to choose biosimilars of trastuzumab. Newer biochemical tools and technology would certainly aid in the  development and processing of biosimilars for patients with breast cancer. In addition, policy statements like the recent one from the American Society of Clinical Oncology (ASCO) [2] would further assist in guiding future activities and strategies for educating the oncology community on the use of biosimilars for cancer patients, especially those with HER2-positive breast cancer.

Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest.

Abstracted by Professor Dr Sarfraz Ahmad, Director of Clinical Research, Gynecologic Oncology Program, AdventHealth Cancer Institute. FSU and UCF Colleges of Medicine, Orlando, FL, USA; and Dr Lyudmila U Sarder, Internal Medicine Residency Program, Lakeland Regional Health Medical Center, Lakeland, FL, USA.

Editor’s comment
Readers interested to learn more about trastuzumab biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in polyolefin bags and elastomeric devices

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References
1. Sarder LU, Ahmad S. Emerging role of biosimilars: focus on trastuzumab and metastatic human epidermal growth factor receptor 2-positive breast cancer. Results Chem. 2023;6:101055.
2. Rodriguez G, Mancuso J, Lyman GH, Cardoso F, Nahleh Z, Vose JM, et al. ASCO policy statement on biosimilar and interchangeable products in oncology. JCO Oncol Pract. 2023;19(7):411-9. doi: 10.1200/OP.22.00783.

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