Experience Equals Trust in Biosimilar Market, Report Says

Experience with biologics and biosimilar products means a high level of trust from US payers, according to a July 22, 2013, press release from BioTrends Research Group. In addition, biosimilars developed by companies with experience in that area are more likely to be reimbursed and are likely to encounter fewer reimbursement restrictions than the branded biologic, the release added.

The report, US and EU Payer Perspectives, could indicate which companies are likely to see success in the future biosimilar market. Released by BioTrends Research Group, the report compiles opinions from 60 managed care organization pharmacy and medical directors in the United States to determine their perspectives on biosimilars and expectations for the biosimilar market.

Areas covered in the survey included payers’ current level of biosimilar awareness, anticipated pricing and reimbursement strategies, and potential drivers and constraints of biosimilar use.

To qualify for the research survey, participants must (1) have worked on pharmacy and therapeutics committees or in formulary management for at least 2 years and no more than 30 years, (2) have worked for a managed care organization with at least 100,000 covered lives, (3) be directly involved in reimbursement decisions, and (4) be familiar with several biologic agents.

Researchers asked participants about their level of trust in several types of companies, including biotech companies with experience manufacturing other biologic drugs, companies with experience manufacturing small molecule generic drugs that have launched biosimilar drugs in Europe, large pharmaceutical companies that have acquired or partnered with either large or small pharmaceutical or biotech companies, new companies spawned from well-known and established biologics companies, generic drug manufacturers that have not yet launched biosimilar products, nonpharmaceutical companies partnering with contract research organizations, and companies from emerging markets with experience marketing biosimilars outside of the United States or European Union.

The report findings mirror prior years’ data, with only a minority of participants believing automatic substitution is a bad idea overall. Despite this, only 25% of those surveyed believed automatic substitution was a good idea. Slightly more than half of payers—55%—believe the practice is suitable for certain drug classes.

According to Andrew Merron, PhD, BioTrends Research Group Senior Director, the trend shows a more discerning attitude toward biosimilars, and a movement away from blanket opinions regarding the therapies. Regardless, the main factor for payers considering biosimilars and brand name biologic medications is equivalence and therapy cost.

“Surveyed US MCO PDs and MDs view clinical equivalence and the cost relative to the branded product as the two most important issues to consider when deciding whether to reimburse a biosimilar,” Dr. Merron said in an email to Specialty Pharmacy Times. “However, the safety of the biosimilar and the designation of ‘interchangeability’ are also weighted highly and significantly greater than most other profiled factors (including immunogenicity and the manufacturer of the biosimilar).”

A slight majority of payers, 58%, felt branded biologics and biosimilars were very similar and possessed nonclinically significant differences. Despite this, 40% of payers felt biosimilar and branded biologics were only somewhat similar and may possess either significant or possibly significant clinical differences.

The sentiment could imply a lack of awareness or need for further education, Dr. Merron noted.

In the United States, FDA approval would address a portion of most payers’ concerns regarding biosimilar substitution, researchers found. Within specific therapies, 23% of payers said FDA approval would alleviate some of their concerns regarding biosimilar monoclonal antibodies (mAbs) and fusion proteins, whereas 40% of payers said the same approval would allay their concerns regarding biosimilar small recombinant proteins.

Although payer skepticism of biosimilars may affect their market penetration, researchers at BioTrends expect payers to be more receptive to add follow-on biologics to their formularies if those products are from large, multinational companies.

Biosimilars for Remicade released in the European Union by Celltrion and Hospira could provide a proving ground for that prediction.

“It’s an interesting scenario because both Celltrion and Hospira will be commercializing biosimilar infliximab in Europe (under Remsima and Inflectra ‘brand’ names, respectively),” Dr. Merron said. “As it stands, we would expect payers to place greater trust in Hospira than Celltrion as a biosimilar manufacturer, but importantly, the biosimilar infliximab molecule from Celltrion and Hospira is identical. If key stakeholders are aware of this fact, then while still an important consideration, the difference in trust between the two companies is a less significant factor influencing penetration. Multiple other factors will contribute to shaping the uptake of Inflectra and Remsima in Europe.”