Biosimilars are biologic medicines that are developed to be similar to an existing Food and Drug Administration (FDA) approved biologic drug, known as the reference product. Biosimilar drugs may provide more treatment options for patients and are likely to reduce healthcare costs over time due to increased competition.

Regulatory Approval Process for Biosimilars

For a Oncology Biosimilars to be approved, the manufacturer needs to show it is highly similar to the original biologic through analytical, animal, and clinical testing. The clinical testing involves a Pharmacokinetic and Pharmacodynamic study that looks at the drug levels in blood and effect in the body in comparison to the reference product. This is followed by a clinical Immunogenicity trial to evaluate the potential of the drug to trigger an immune response.

If no clinically meaningful differences are found between the biosimilar and reference product in terms of safety, purity, and potency, extra clinical trials testing effectiveness are not required for FDA approval. However, ongoing safety surveillance is important to ensure the biosimilar drug remains comparable to the reference product over time.

Biosimilars for Cancer Treatment

The first biosimilar drug approved by the FDA in 2015 was Zarxio, a biosimilar to Neupogen used for reducing infection risk in cancer patients undergoing chemotherapy. Since then, multiple oncology biosimilars have been approved for cancer treatment indications such as breast cancer, colorectal cancer, and non-small cell lung cancer. Some of the leading oncology biosimilars are:

- Truxima - A rituximab biosimilar for non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

- Ruxience - A rituximab-pvvr biosimilar for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

- Herzuma - A trastuzumab biosimilar for HER2-positive breast cancer and metastatic gastric cancer.

- Ontruzant - A trastuzumab biosimilar for HER2-overexpressing breast cancer and metastatic gastric cancer.

- Ogivri - A trastuzumab biosimilar for HER2-overexpressing breast cancer and metastatic gastric cancer.

Cost Savings with Oncology Biosimilars Drugs

The introduction of biosimilars in oncology is proving beneficial from a cost perspective. Since their approval, the FDA has reported aggregated cost-savings of over $1 billion from the use of biosimilar drugs in the United States. Due to increased competition in the market, the entry of multiple biosimilars for a given reference product often results in significant price reductions.

For example, filgrastim biosimilars Zarxio, Nivestym, and Nyvepria launched at 15-25% below the reference drug price of Neupogen. This has translated to average cost-savings of 40-60% for healthcare payers. Similarly, the rituximab biosimilar Truxima is priced 10-15% lower than the reference biologic Rituxan. Greater cost-savings are expected as the rituximab market becomes more competitive.

The cost benefits with biosimilar usage allow for the expansion of treatment access. More patients may qualify for cancer therapies that are often cost-prohibitive. Healthcare systems can treat higher volumes at lower costs as the rising budgets for cancer care become sustainable over time.

Impact on Innovation

While biosimilars reduce costs in the short-term, there are also long-term benefits for research and innovation. The economic gains from a competitive biosimilar market can be redirected towards the development of novel therapies. Competition from biosimilars puts pressure on biologic manufacturers to invest more in next-generation follow-on biologics with improved formulation, delivery, or other advantages over existing products.

Overall, Oncology Biosimilars have emerged as a critical part of the future of cancer treatment. They offer more affordable access to life-saving biologics while supporting continued medical advancement through reinvestment. With the FDA approval pathway now well-established, more biosimilars are anticipated to enter the oncology market in the coming years. This will significantly improve patient outcomes and sustainability of healthcare systems.
Get More Insights on- Oncology Biosimilars

Explore More Related Article On- Antidepressant Market

Discover the Report for More Insights, Tailored to Your Language:

• French
• German
• Italian
• Russian
• Japanese
• Chinese
• Korean
• Portuguese

About Author:
Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. (https://www.linkedin.com/in/ravina-pandya-1a3984191)