ASCO Issues Statement on Biosimilars in Oncology

This week, the American Society of Clinical Oncology (ASCO) released a new statement that seeks to offer clinicians guidance on the use of biosimilars in oncology as a wave of patent expirations is expected to bring more anti-cancer and supportive care biosimilars to the US market.

Safety and Efficacy

ASCO’s statement notes that, given the FDA’s approach to biosimilars—which does not include large, phase 3 studies for all indications but allows for the extrapolation of indications—postmarket evidence will be important to demonstrate the value of biosimilars to stakeholders, and clinicians will play a key role in postmarket surveillance.

However, current capabilities for postmarket surveillance have shortcomings, and the FDA’s Sentinel system, which should allow the FDA to actively query electronic health records, administrative and claims databases, and registries to evaluate any potential safety issues, is still in development. ASCO’s own big data candidate, CancerLinQ, has potential value in tracking biosimilar use and effectiveness, according to the paper.

Interchangeability, Switching, and Substitution

ASCO explains that the Biologics Price Competition and Innovation Act provides for pharmacy-level substitution of biosimilars that have been granted interchangeable status by the FDA (a designation that includes evaluation of the safety of switching multiple times between the biosimilar and its reference). However, ASCO emphasizes that prescribers should always be consulted before a pharmacist substitutes a biosimilar for a reference product. According to ASCO, physicians and patients should be notified about any potential substitutions so that they can make informed treatment choices.

Naming and Labeling

Oncologists, prescribers, patients, and pharmacists should be able to easily identify products and ensure that patients receive the correct therapy, says ASCO, and the complexity of biosimilars warrants a naming and labeling system that differs from that of conventional drug products. The position paper explains that the FDA requires a 4-letter suffix, devoid of meaning, for biosimilars’ names, but does not take a position on whether this system, which has been controversial among some stakeholders, is the best approach.

With respect to labeling, ASCO explains that “The FDA maintains the presumption that the biosimilar designation is sufficient to support manufacturer claims of safety and efficacy. As such, merely citing the reference product in the labeling would be appropriate and could convey all necessary information for therapeutic decision making.” In cases in which indications, dosing, or storage of the biosimilar may diverge from that of the reference, statements that highlight these differences must be present.

Once interchangeable biosimilars are available, inclusion of information related to interchangeability will be necessary, as will clarity on the naming of such products.

Reimbursement, Coverage, and Cost

“Reasonable compensation, fair and medically appropriate coverage, and transparency of cost will serve to ensure a true value benefit to patients and society and promote access to new and innovative therapies,” writes ASCO. The paper notes that, while biosimilars and their relationship to their reference products “call for policies that are associated with generics” in order to limit patients’ out-of-pocket costs, if a biosimilar is not interchangeable, it could be subject to policies that cover single-source and non-preferred products. ASCO urges the development of policies that ensure the delivery of quality care and uphold patient access.

Prescriber and Patient Education

ASCO says that it will continue to provide education on biosimilars, and that “A broad range of educational materials, sources, and formats developed through a peer-review process, including appropriate conflict of interest provisions, must be readily available to all stakeholders.” ASCO adds that practice guidelines for biosimilars will be an important part of oncologists’ education.

The position statement points to the potential to develop webcasts, online practice guides, and social media updates via ASCO University, and says that educational sessions on biosimilars at scientific meetings will be necessary. The FDA will also hold educational webinars on biosimilars that will be of use to healthcare professionals.

Patient-focused educational materials may also be developed for ASCO’s Cancer.net website, and ASCO’s Meeting Library. However, says the paper, “For patients, the best source of patient education is the treating physician, regardless of the prescribed drug.”

Reference

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E. American Society of Clinical Oncology statement: biosimilars in oncology [published online February 14, 2018]. J Clin Oncol. doi: 10.1200/JCO.2017.77.4893.