Should Biosimilars Be Interchangeable with Biologics?

Interchangeability is the real question.

Although US regulators continue to struggle with the interchangeability of approved biologics and biosimilars, one policy researcher believes that there is already enough evidence to prove that biosimilars are equivalent to biologics and should be used interchangeably. Canadian drug policy researcher Alan Cassels, of the University of Victoria, British Columbia, Canada, wrote in the January 2017 issue of Clinical Pharmacist that a large body of evidence already demonstrates the interchangeability of approved biosimilars, and this proof ought to outweigh pharmaceutical companies’ interests and open the door to saving billions of dollars.

As Cassels explains, biosimilars already on the market in Europe are estimated to be 10% to 70% cheaper than brand-name counterparts. A recent audit by the Royal College of Physicians suggests that if all UK patients being treated with a monoclonal antibody received biosimilars, the UK’s National Health Service would save 3 million pounds per year and still realize the same health outcomes.

The audit found that infliximab biosimilars were equally effective and safe compared with the originally patented medication, Remicade. Cassels also points to the widely discussed study in the August 2016 Annals of Internal Medicine by G. Caleb Alexander and colleagues at the Johns Hopkins Center for Drug Safety and Effectiveness, which concluded that biosimilars of Remicade appeared to be just as safe and effective as Remicade, and were far less expensive.

[] However, when the FDA approved Pfizer’s biosimilar infliximab (Inflectra), it was not designated as interchangeable with Remicade, so in some states pharmacists will not be able to switch patients from Remicade to Inflectra. To date, none of the four biosimilars to be approved by the FDA are interchangeable.

The interchangeability of biosimilars could have a big impact on pharmaceutical spending worldwide. Biologics such as Remicade and Enbrel account for approximately a fifth of all US drug spending. Global spending on biologics is predicted to reach $221 billion in 2017. Because approximately $71 billion in patented biologics will have their patents expire by 2020, Cassels explains, there is a race to produce biosimilar products to sell at a discount and capture the market.

So what’s holding biosimilars back? The lack of interchangeability.

Attitudes about biosimilars and interchangeability vary around the world. In the European Union, the approval process for biosimilars involves comparing biosimilars with their reference medicines to show that there are no significant differences between them. However, the EMA does not make recommendations about whether a biosimilar can be used interchangeably with its reference medication. Rather, the EMA suggests that patients should speak to their doctor and pharmacist if they have questions about switching from one biological medicine to another. Taking a different approach, Australia’s drug advisory committee recommends that biosimilars are suitable for substitution at the pharmacy level.

In the United States, health insurers are interested in introducing biosimilars to control drug costs. But drug companies are simultaneously “crafting defensive strategies to protect sales of branded biologic drugs while also developing biosimilars of their own.” Cassels says the defensive strategies include lobbying medical professionals and the public that biosimilars cannot be interchangeable because there are too many variations related to their complexity, and that the FDA alone must designate interchangeability to ensure patient safety --criticisms he calls unsupported and intended to slow down or derail the use of biosimilars and prevent health systems and patients from saving money on these new less expensive, effective, and comparable therapies.

Cassels concludes, “Pharma and the drug lobby are weak in their efforts to discredit biosimilars and imply lower levels of safety and tolerability compared with their originator products. Research suggests no substantive outcome differences between the use of originator biologics and their biosimilar counterparts, and arguments against their effectiveness and safety fall flat.”