The High Cost of Delays in Biosimilars Hitting the US Market

Study estimates United States is wasting $45 million every month that biosimilar Zarxio is not on the market.

Estimates vary regarding how much of an impact biosimilars may have on US specialty drug spending. There is little debate, however, that for each day biosimilars are delayed from hitting the market, consumers are being denied relief from high drug prices.

A recent report by Express Scripts illustrates just how much of an impact these delays are having. On the heels of the approval of the first biosimilar in the United States earlier this year, Filgrastim-sndz (Zarxio), Express Scripts estimates more than $45 million has likely been wasted for every month Zarxio is delayed from hitting the market.

“Biosimilars will do for the biotech market, primarily made up of very expensive injectable drugs, what generic drugs did for traditional oral solid pills a decade ago: lower the cost for safe, effective treatments that improve and save lives,” the Express Scripts report authors wrote. “They will revolutionize the category of spending that is among the fastest-growing and most worrisome for payers who want to continue providing sustainable, high-quality benefits for their members.”

Zarxio, manufactured by Sandoz, Inc and approved by the FDA on March 6, 2015, is biosimilar to Amgen Inc’s filgrastim (Neupogen), which was originally approved in 1991. The release of Zarxio was delayed as a result of litigation between the two manufacturers.

However, after an appeals court ruling on July 21, 2015, Zarzio is expected to hit the US market on September 2. Neupogen garnered $1.4 billion in sales last year, with approximately 84% of those sales in the United States.

Another biosimilar application accepted by the FDA last year for infliximab (Remicade) by Johnson & Johnson would bring relief to consumers who use the drug for conditions such as rheumatoid arthritis and Crohn’s disease. Remicade sales reached $8.4 billion last year.

Express Scripts previously estimated that approximately $250 billion could be saved over the next decade if 11 biosimilars were to be approved. In addition to Neupogen, these biosimilars are:

• Bevacizumab (Avastin)
• Epoetin alfa (Epogen)
• Trastuzumab (Herceptin)
• Adalimumab (Humira)
• Interferon alfa-2a (Intron A)
• Pegfilgrastim (Neulasta)
• Peginterferon alfa-2b (Pegintron)
• Epoetin alfa (Procrit)
• Infliximab (Remicade)
• Rituximab (Rituxan)

Express Scripts noted that biosimilars approved in Europe, Japan, and other countries worldwide have prices 30% lower than their brand name counterparts.

Biosimilars still face a number of hurdles in the United States before widespread adoption is achieved.

“Biosimilars, developers know very well, are evaluated case-by-case and at this point this is probably the right thing to do. There is no standard for what are the biosimilarity margins, for example. Each molecule is different depending on the molecular characterization,” said Javier Coindreau, MD, vice president of global medical affairs for Pfizer Biosimilars Business Unit in an interview with Specialty Pharmacy Times. “The margins for biosimilarity will be different from molecule to molecule when we move to the clinical development level. That natural lack of clarity is something we think will improve in time as we in the industry and the regulatory bodies learn more about the aspects that impact biosimilarity. But I think this is a natural phenomenon we have seen in the past and only experience will clarify many things.”

Naming conventions also create an issue that still needs clarity. Companies who manufacture the brand name drugs want biosimilars for their products to have a distinct generic name, which is in contrast to traditional drugs where multiple manufacturers can call their product the same name.

However, biosimilar manufacturers counter that this may lead to unnecessary confusion, causing patients to believe biosimilars lack the safety and efficacy of the originator product. The FDA on August 27, 2015 proposed a plan to attach a unique 4-letter suffix on biosimilars to the brand it copies.

“We need to find a way to communicate the importance of biosimilars and the high potential they have, especially the quality behind the molecules and how the entire concept of biosimilarity is based on the molecular structure of the candidate drug. It is a big challenge,” Dr. Coindreau said.