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Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010, biosimilars have been developed and marketed as competitive, lower-cost alternatives to newer biologic treatments. This pathway was established to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.1
Biosimilars are among the fastest-growing class of drugs in the United States, a class called biological products. Biosimilar products are highly similar to and have no clinically meaningful differences from existing Food and Drug Administration (FDA)-approved biological products, known as reference products or originator products.2
Biosimilars differ from generic drugs, in that generics are identical copies of brand-name drugs made by different drug companies, whereas the manufacturing process for biologic treatments is so complex that it is not possible for a different manufacturer to make an identical copy. However, both generics and biosimilars tend to be less expensive than their brand-name or reference product counterparts, which is exciting for the cancer care community given that eight of the 10 most expensive drugs on the market are cancer drugs.
In 2010, a streamlined process for the approval of biosimilar products was created as part of the Patient Protection and Affordable Care Act. A biosimilar product is required to have the same active mechanisms, conditions of use, and administration method and dosage as the approved product. Only minor differences in clinically inactive components are allowable.
To submit a biosimilar product for FDA review, manufacturers must complete an application that includes the following data as evidence of a product’s biosimilarity:
- Analytical studies
- Animal studies (including a toxicity assessment)
- Clinical studies (or a single clinical study) demonstrating the product’s safety, purity, and potency in at least one of the conditions for which the already license product is approved for use. Examples include an immunogenicity and pharmacokinetics or pharmacodynamics assessment.
To date, FDA has approved 10 biosimilars for use in the United States, two of which were approved to treat cancer, and two others have been approved as supportive care agents in the cancer setting.
What’s Next for Biosimilars?
Given the expiration of several biologic drug patents, a wave of biosimilars is expected, and cancer treatments will likely comprise a significant number of those approvals. While many new biosimilars will likely be available in oncology in the next several years, their impact on patient care will depend largely on patient and provider acceptance—based on an adequate understanding of the safety and efficacy—of these agents.
In February, ASCO’s statement on biosimilars in oncology was published in the Journal of Clinical Oncology. The statement examines a range of issues to help the cancer care community better understand the impact of biosimilars on oncology care. ASCO’s statement offers guidance on: (1) naming, labeling, and other regulatory considerations, (2) safety and efficacy, (3) interchangeability, switching, and substitution, (4) value, and (5) prescriber and patient education.
ASCO’s statement affirms the society’s ongoing commitment to enhancing confidence in biosimilars through provider education and advocacy for federal and state policies that ensure efficient approval, unrestricted access, and appropriate use of biosimilars.
Key Data Points
- To date, the Food and Drug Administration (FDA) has approved ten biosimilars for use in the United States, two of which were approved to treat cancer, and two more were approved as a supportive care agent in the cancer setting.
- Oncology biologic products with patents scheduled to expire by 2020 total global annual spending of more than $20 billion.
- Beginning January 2018, for newly approved biosimilar products, biosimilars with a common reference product will no longer be grouped into the same billing code. CMS will code each biosimilar separately and reimburse at the current rate of ASP + 6%.
- American Society of Clinical Oncology Statement: Biosimilars in Oncology
- Educational Materials on Biosimilars for Health Care Professionals
- FDA’s Biosimilar Product Approval Process: A Closer Look
- ASCO Comments to FDA Commissioner on Interchangeability of Biosimilars
- FDA's Biosimilars Page
- Biosimilars and Cancer Care: An Expert Opinion
2. “Biosimilars.” U.S. Food and Drug Administration. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars. (Accessed May 2018).