Biosimilars in US: Expert Panel Debates Current and Emerging Issues

The Alliance for Health Reform hosted an event on the topic of biosimilars on May 20, 2015 in Washington, DC featuring panelists from FDA, Amgen, and Hospira. Although biosimilars are expected to cut spending on biologics by $44 billion according to a RAND Corporation estimation, it takes up to eight plus years to develop a biosimilar, and $100–200 million dollars to bring one to market, estimated Sumant Ramachandra, MD, PhD, senior vice-president and chief scientific officer of Hospira. He said that on top of that figure, a biosimilar also “must have capital investments.”

Diversity among biologics influences policy on these medications, said Geoff Eich, executive director, external affairs for Amgen Biosimilars, and as a result, he expects biosimilar launches to look more like those of branded biologics than generic drugs. Physician acceptance, accountable manufacturers, and healthcare professional education are among the key factors influencing biosimilar acceptance, he noted. While there is an abundance of interest in labeling and technical guidance for biosimilars, the presentations at the meeting centered specifically around naming, extrapolation, and the coding and reimbursement of these biologic products.

Naming
There is concern that the unique naming of a biosimilar will put it at a disadvantage to innovator products, said Sally Howard, JD, deputy commissioner for policy, planning, and legislation at FDA. She said a naming policy from FDA will be released in late 2015, but reminded the audience that levers outside of FDA control-such as payers, formularies, and state pharmacy substitution laws-could influence biosimilar adoption as well. Sumant Ramachandra, MD, PhD, senior vice-president and chief scientific officer of Hospira, said that Hospira supports the use of the same international non-proprietary name (INN) for biosimilars, and that the use of unique INNs would add more complexity and is “not recommended.” Pharmacovigilance can exist in the absence of unique INNs, Ramachandra said; this has already been the case in European markets.

When asked by an audience member if INNs should apply retrospectively, Howard said this issue is something FDA is struggling with and is the reason “why you don’t see a naming guidance out yet.”

While Eich said, “I don’t need the reference product to have a change in its name,” Ramachandra commented, “if there is going to be a change of policy, it should encompass the field.” He said that if additional qualifiers for biosimilars are added, to keep the field “even and competitive,” reference products should have qualifiers as well.

When it comes to naming, a major concern is how a biosimilar will be identified when there are adverse events. Eich said that pharmacists report 5% or less of adverse events to FDA and that a disproportionate majority of reporting is from patients or other healthcare providers. Eich said that accurate patient histories are a must, and that early adoption of biosimilars will rely on “credible transparent data.”

Extrapolation
As Howard pointed out, products submitted via section 351(k) of the Biologics Price Competition and Innovation Act will not be tested in Phase I–III trials. Because there are fewer clinical trials being conducted, biosimilars could offer a 20–30% discount, said Ramachandra.

Ramachandra called the allowance of extrapolation the “single most important tenet for the sustainability of biosimilars.” He said that as long as there are no clinically meaningful differences, FDA should allow extrapolation without the requirement of additional clinical trials. FDA’s Howard added, “Differences between conditions of use do not necessarily preclude extrapolation.”

Appropriate coding and reimbursement
Amanda Bartelme, director, Avalere noted that coding of biosimilars is still being sorted out, and it is unclear to date if all biosimilars will be coded the same way for reimbursement purposes. Ramachandra said Hospira supports unique reimbursement codes for biosimilars and added that grouping all biosimilars with the same J-code will create disincentives. Each biosimilar should have a different J-code, he said. Eich said that even if a product is deemed interchangeable, it should be coded separately: “There’s great value and need to be able to aggregate data, but we cannot exist in a place where we cannot disaggregate data to a specific product … it’s a scientific disservice.”