Biosimilars May Change the Treatment Landscape for Inflammatory Diseases

BIOSIMILARS HAVE SIGNIFICANT potential to lower escalating drug spending in the United States, but their adoption into practice in this country has been sluggish; however, this trend may soon change. Merck recently announced the launch of Renflexis (infliximab-abda), the second biosimilar version of the blockbuster drug, Remicade (infliximab). The first Remicade biosimilar, Inflectra (infliximab-dyyb) from Pfizer, launched in late 2016.

During the recent Peer Exchange®, “Clinician and Managed Care Insights on Biosimilars for Inflammatory Diseases” hosted by The Center for Biosimilars™, an expert panel provided an overview of biosimilars, clinician and patient understanding of the biologics landscape, and access considerations with a focus on inflammatory conditions. The panel included moderator Peter L. Salgo, MD, along with experts Allan Gibofsky, MD; Gary R. Lichtenstein, MD; Vibeke Strand, MD; and Cole Wilson, PharmD.

Although biologics account for less than 1% of all prescriptions dispensed in the United States, they represent one-fourth of all US prescription spending, according to Dr. Salgo. The high cost of drugs is an increasing concern, and biosimilars offer hope as a less costly alternative for patients treated with specialty medications. Despite this potential, the adoption of biosimilars has been slow, due in part to knowledge gaps regarding biosimilars among health care professionals, according to the panel.

“I think (biosimilars) have the real potential for lowering costs to the system and possibly increasing resources for patients and increasing their access,” Dr. Gibofsky said. “I think we still need some of that evidence to accrue before we’re fully comfortable, but I do think that the ability to use these drugs more widely will be a significant advantage in the treatment of the chronic inflammatory diseases we’ve been talking about.”

Although different representative organizations have launched programs to increase awareness, such as the American College of Rheumatology’s new Biosimilars Awareness Education Program, education overall is still lacking. Dr. Gibofsky believes the gap lies between the time that the FDA takes regulatory action and when the drug finally becomes available––which can be at least 6 months, maybe longer. “The knowledge base is building out there, but there are still some misunderstandings that have to be corrected,” he said.

Biosimilars contain living organisms and are designed to be highly similar to the reference product, but not identical. They are manufactured based on knowledge of the primary structure of the reference product—ultimately reverse engineering them. The primary structure, which is the sequencing of amino acids, needs to be the same for a biosimilar and its bio-originator, Dr. Gibofsky said.

“There can be difference in the molecule between a biosimilar and a bio-originator (the reference molecule), but they can’t be clinically meaningful,” Dr. Gibofsky said. “They can’t affect the safety. They can’t affect the efficacy. They can’t affect the purity or the potency of the molecule that we’re dealing with.”

The repurposing of drugs is gaining attention in the research world, in which biologic drugs indicated for a specific disease are being used to treat other diseases. Within the framework of biosimilar development, the FDA has allowed interchangeability for specific areas initially approved for the originator product.

“I think one of the concerns is that the FDA has made it very clear that the label for a biosimilar is identical to the label for the reference product,” Dr. Strand said. “That’s going to make it very hard for people to try to figure out how to report pharmacovigilance.” For biosimilars, 28 states currently allow interchangeability. According to Dr. Wilson, the standard for generic products that have been on the market is not the same standard for biosimilars.

Biosimilars are designed with a goal to decrease drug costs and ultimately increase patient access. This decrease in cost is associated with how well the manufacturer of the biosimilar can negotiate compared with the negotiation skills of the manufacturer of the reference product.

“You can anticipate that you’re not going to see the bio-originator manufacturer stand still while someone else comes in and tries to eat their lunch,” Dr. Gibofsky said. “So, I’m not surprised to hear that there may be systems in which the bio-originator is priced even lower than the biosimilar, which was promised to be the reduced price.”

It is difficult to determine which drug will be cheaper, and by how much, due to the role pharmacy benefit managers play in making the decisions and the discount portfolios, according to the panelists. With the portfolios, there may be discounts for uses of various products—and there is no way of knowing what those discounts are.

Dr. Gibofsky spoke about his personal comfort level of biosimilar use by dividing patients into 3 categories: new starts, stable, and sleeping baby. For new-start patients, it is difficult to argue against putting them on a biosimilar. For patients who are stable and achieved that state relatively easily, it would not be that difficult to switch them to a biosimilar. But challenges arise in patients who have struggled to get to the point of low disease activity and remission. This type of patient is referred to as a “sleeping baby” because you don’t want anything done to disturb them. It would be difficult to switch the patient, and they would have more difficulty accepting the switch to a biosimilar, according to Dr. Gibofsky.

Two European switch clinical trials funded by the Norwegian and Danish governments examined the effects of switching from a bio-originator drug to its biosimilar. The results showed noninferiority when comparing the 2 products, according to the panel. Although there is promise when switching products to formulary or considering the use of biosimilars, the question remains whether the European studies are translatable to the United States and how this will that affect formularies, Dr. Salgo noted.

As far as costs in the rheumatology space, biosimilars typically start off slightly less expensive, but their threat is causing a cost reduction across the market. The current challenges with insurance companies and bio-originators will largely be the same with biosimilars. Dr. Gibofsky believes the prior authorization requirements and hurdles will be the same for biosimilars. “I think we are going to see insurance companies selecting favorite agents based on factors unrelated to their clinical applicability,” he said.

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