The U.S. Food & Drug Administration (FDA) defines a biosimilar as a biological product that resembles an existing FDA-approved product with no clinically significant differences. In 2009, the Biologics Price Competition and Innovation Act (BPCIA) paved the way for biosimilar agents to gain approval in the United States. The BPCIA’s section 351(k) of the Public Health Service Act of 1944 was updated, which provided specifics on biosimilar requirements for licensing, testing, manufacturing, safety, exclusivity, labeling, the definition of biosimilars versus interchangeable products, and required interactions with the manufacturer of the reference product. The BPCIA became part of the 2010 Affordable Care Act, and led to anticipation of these agents coming to market from key healthcare players, including health benefit providers (payers), manufacturers, and healthcare providers.
As biosimilars have been integrated into the U.S. healthcare market, healthcare providers, drug manufacturers, specialty and infusion pharmacies, payers, and policymakers have had mixed responses. Biosimilars provide patients with access to medications at a significantly lower cost than the reference biologics, but they have also impacted drug pricing, formulary coverage, reimbursement, and clinical utilization. Oncology pharmacists became more familiar with these agents after the first biosimilar was approved in the United States: filgrastim-sndz. Two years later, two biosimilars—bevacizumab-awwb and trastuzumab-dkst—were approved to treat cancer.
A list of all FDA-approved biologics—including medication names, licensure dates, patent expiration dates, and more—is available via the FDA’s Center for Drug Evaluation and Research’s online database, called the Purple Book. As of now the BPCIA pathway has led to FDA-approval for six biologics, three of which are currently on the market. Approval, manufacturing, and sales of numerous biosimilars have been stalled due to lawsuits that have resulted from varied interpretations of both patent law and the BPCIA-required communication required for manufacturers.
To date, there are no biologics on the market that can substitute the reference product without intervention from the original prescriber. While biosimilars are not an exact replica of their reference product, manufacturers must adhere to or provide stringent clinical, safety, purity, potency, analytical, and nonimmunogenicity information that demonstrate the biosimilars’ equivalence to the original. One criticism of biosimilars is that they may receive FDA approval for all indications as the reference product even if the biosimilar has only been tested for one indication; however, the FDA’s approval process, the adoption of biosimilars in Europe, and preliminary U.S. data support the belief that biosimilars resemble the reference product.
Biosimilars also have a large effect on cost and patient access to treatment. The U.S. healthcare system could potentially save $54 billion over the next decade (minimum, $25 billion; maximum, $150 billion) with the implementation of biosimilars, according a market study by the RAND Corporation. As biosimilars enter the market, the cost of the reference products may also decline, as manufacturers try to compete with the biosimilar prices. Pharmacies and clinics would buy the cheaper medications, individual health insurance beneficiaries would pay less, and patients would have lower premiums and copays.
As biosimilars have the potential to change the market, dispensing pharmacies must understand what this means. Most oncological biologics close to their patent expiration date—making them eligible for market competition—are intravenously administered by a healthcare professional. Nearly three-quarters (72%) of payers cover intravenous products in the oncologic setting specifically under the medical benefit. Revenue cycle billing via the medical benefit may result in infusion pharmacies giving nonpreferred or uncovered products, thereby foregoing payment for services rendered. If a payer receives a biosimilar when their preferred formulary agent was a reference product (or a different biosimilar), or vice versa, infusion pharmacies may not receive payment through the medical benefit. Infusion pharmacies may also lose payment if there is biological parity but no authorization was obtained, authorization was received for a different product than what was dispensed, prescription insurance approved the medication but medical insurance billed it, or the patient recently lost or changed their benefits.
Medicare and other payers cover biologics in all forms if there is biological parity, making it vital for oncology infusion pharmacies to be educated on purchasing costs for the reference and biosimilar products, as well as their respective reimbursement. Even if one product is cheaper, it may have a much lower reimbursement, yielding a smaller margin per each dispensing. Medicare Part B has tried to incentivize beneficiaries to use biosimilars by favorably reimbursing for them, but these reimbursement methodologies have undergone numerous changes recently, making it even more critical to stay abreast of industry standards.
Source: HOPA News