Biosimilars at the Gates: What's Ahead?

May 3, 2017
Jackie Syrop

Biologics are the fastest-growing segment of the medication market, and the most expensive within the immune sector. The average prescription for these breakthrough specialty biologic treatments for inflammatory diseases costs over $3500. The top 5 drugs in the class include Humira Pen, Amgen’s Enbrel (etanercept), Humira for rheumatoid arthritis (RA), Celgene’s Otezia (apremilast) for plaque psoriasis, and Janssen Biotech’s Stelara (ustekinumab) for plaque psoriasis, psoriatic arthritis, and Crohn’s disease. While Humira and Enbrel together captured 70% of the market share in 2016, Humira alone. the world’s best-selling drug, earned $14 billion in 2015.

Five biosimilars have been approved by the FDA to date, 4 of which are in the autoimmune category and are biosimilars to Enbrel, Remicade (infliximab) and Humira; the fifth is a biosimilar to an oncology drug. Biosimilars of biologics promise lower prices for their versions of these highly effective biologics, and thus can potentially treat more patients. The Congressional Budget Office estimates that potential biosimilar savings over the next 10 years would be $25 billion; other reports estimate that figure at up to $250 billion. Price discounts for biosimilars range from 15% to 25% but that doesn’t account for discounts expected by patients and payers, which could be up to 50% in the autoimmune category. For this to occur, competition has to increase, but so far, the reference biologic makers are doing whatever they can to hold back competition from biosimilars.

The Humira and Enbrel biosimilars that were FDA approved have been hit by patent lawsuits brought by reference drug makers, which has prevented product launch. Patent legislation fights continue to hold back biosimilars in the marketplace, forcing biosimilar makers to wait longer to reach market. For example, AbbVie filed a patent infringement suit against Amgen to block the launch of its biosimilar adalimumab. AbbVie continues to invest in new Humira indications and enhancement for patients with unmet medical needs. Amgen sued Novartis/Sandoz with a patent infringement suit for Enbrel that was recently heard by the US Supreme Court.

Slow acceptance of biosimilars is due in part to the fact that many physicians and payers do not agree with using biosimilars for patients with RA, psoriasis, and other inflammatory conditions. Some welcome biosimilars and believe they are a solution to the high prices of biologic treatments, but others are opposed to biosimilars and are concerned they won’t work as well as brand-name reference biologics they would substitute for. Patients too are unsure they want to have biosimilars switched for their effective, breakthrough biologic treatments.

None of the approved biosimilars have an interchangeable designation because their approvals predated the FDA’s 2016 guidance calling on biosimilar makers to produce switching-study data to show interchangeability with reference drugs. In Norway, the government funded an interchangeability study for a Remicade biosimilar, and the ensuing proof of interchangeability had a profound effect on Norway’s use of an infliximab biosimilar. Some experts say that if major US health insurers sponsored biosimilar interchangeability studies here, there could be a parallel upswing in biosimilar use. However, the downside of the switching-study guidance is that it will raise costs for biosimilar makers and cause longer wait times to marketing—potentially raising the investment hurdle too high and knocking out smaller biosimilar makers.

If biosimilars start moving to market more quickly, brand manufacturers will likely respond with lower product prices, says Stephan Gauldi, senior vice president of strategy consulting at Back Bay Life Science Advisors, because they won’t be able to compete on price. “Biologics would emphasize brand and biosimilars would emphasize price, assuming interchangeability is sorted out first,” Gauldi said.

For biosimilars to make inroads in the United States, healthcare providers and patients would have to be better educated about biosimilars. Biosimilars will only be successful if sponsors are able to establish positive perceptions of their products and create a comfort level for patients and providers to accept and adopt biosimilars. Biosimilar makers must define their product and explain how they compare with biologics, and they must be able to answer patients’ questions about efficacy, safety, and side effects, and compete with reference drug makers’ programs providing support and services for branded drugs. “They feel they have the most to lose,” notes Rafal Kokolus, senior engagement manager at inVentiv Health Consulting.

Related Content:

News | Regulatory | Business | Legal