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Biosimilars and Pharmacovigilance: What’s Ahead

Posted on May 20th, 2016 by in Pharmacovigilance

DNA Magnification

DNA Magnification

In our first blog in this series, we drew from a recent IMS report  to demonstrate the market potential of biosimilars. But that same report also summarizes the “risks” to realizing that potential, including  payer policies that hamper competition; reimbursement issues; and insufficient education and evidence to support physician decision making.

Stakeholders reportedly believe that the delay in embracing biosimilars in the US is due mainly to regulatory issues, though Medicare’s reimbursement policy—paying physicians and hospital outpatient departments the average sales price of a drug plus 6% — doesn’t help; that policy provides an incentive to prescribe more expensive drugs, while one of the benefits of biosimilars is lower cost.

A Medicare Part B reimbursement model proposed last month could make a difference—although right now, according to a report released April 12 by Avalere,  Medicare beneficiaries are likely to pay more for biosimilars than for their reference product.

Reimbursement issues and other considerations regarding prescribing of and access to biosimilars and reimbursement are likely to affect market growth, at least in the short term. In addition, the FDA’s lack of clarity regarding interchangeability has led some clinicians to question the safety of biosimilars, noting that even if additional clinical data is required for approval, long-term data is still lacking. The implication for pharmacovigilance, as noted in our second blog, is to be proactive by gathering and keeping all available safety data about the reference drug and of any biosimilars in development by your company or others.

As these issues play out, some believe a “new wave” of biobetter drugs might push biosimilars aside. A recent IBM presentation  suggests that biobetters are superior to both biologics and biosimilars, and notes that close to two dozen biobetters currently are in development.

A biobetter is in the same class as an existing biologic but is not identical to it; instead, it’s  “engineered with improvements,” such as a longer duration of action. That said, biobetters are essentially new entities and must go through the same approval process as any new biologic; savings to companies are primarily in early stage R&D —and, as new entities, biobetters are patentable for 12 years.

Pharmacovigilance for a second-generation biologic is likely to be simpler than for for a biosimilar, especially if companies inform the development of that biologic based on what was learned from developing the original product. Companies that did not produce the original product need to be proactive to obtain as much information about that biologic as possible, not only from the literature, but from clinical trials data and regulatory reports.

Despite the challenges inherent in bringing biosimilars into the real world and potential competition from biobetters, evidence suggests the biosimilar market will continue to grow. A recent analysis of 234 peer-reviewed articles and conference contributions showed a shift in the attitude of the scientific community from skeptical to positive over the past decade. The findings, along with current and emerging regulatory frameworks and technological improvements in the production of biosimilars suggest that biosimilars are “destined to become an integral part of medical care in the future…”

Having a robust pharmacovigilance program in place to inform biosimilar product development and handle the demands of adverse event tracking and reporting will position companies to take advantage of the emerging market.

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