According to industry experts, the biosimilars market is set to take off in the US over the coming years. While Europe has been making biosimilar drugs available to patients for over a decade, with 27 now approved for use, the US has been much more reluctant to accept this new treatment option. The first biosimilar was not approved in the US until 2015, and since then, only four more have been approved by the FDA.
However, it seems that all this could be about to change. With the potential to save the US healthcare system over $250 billion dollars by 2024, biosimilars are now finally being recognized as hugely important additions to the US medicines market.
Drug companies, especially those involved in the oncology, immunology, and diabetes spaces, have been quick to get involved. There are five more biosimilar drug approvals pending this year and over 400 biosimilar drugs in the pipeline, with one third already in the clinical development stage.
Retailers and PBMs (Pharmacy Benefit Manager) are also on board. Two of the country’s largest pharmacy retail chains, CVS and Walgreens, as well as the country’s largest PBM, Express Scripts, have all expressed their support for biosimilars.
“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,” Express Scripts wrote in a report on biosimilars.
Furthermore, according to Ray Tancredi, the Divisional Vice President for Specialty Pharmacy Development for Walgreens, having biosimilars on the market will increase treatment options for patients and hopefully improve patient health. “Choice is always good. It gives the physician, the patient, and the health plan the benefit of choosing a drug that’s right for the patient.”
The FDA has also shown its support for biosimilars by releasing multiple guidance documents for industry. These documents can be found on the FDA website and cover topics including the development and labelling of biosimilars, as well as considerations for interchangeability with a reference listed drug.
However, despite the growing acceptance of biosimilars, there are still some challenges that will need to be overcome before the US can catch up to Europe.
First of all, there is the issue of interchangeability. Unlike generic drugs, biosimilar drugs cannot be made identical to reference products, due to their complexity. This means that they cannot necessarily be used interchangeably with brand name drugs upon receiving approval, unless they pass additional interchangeability tests. Of the five biosimilars that are currently approved, none have been shown to be acceptable for interchangeable use. As such, pharmacists cannot dispense any of these biosimilar drugs without receiving prescriptions written specifically for them.
This leads to the next issue the US is currently facing. Because biosimilars are a relatively new phenomenon, and because the standards for approving these products are still being ironed out, some health-care professionals and patients are still apprehensive about prescribing and using these drugs. As industry and government continue to show their support for biosimilar drugs, confidence about their use among physicians and patients should grow. However, until these important players in the healthcare system are fully on board, it may be a while before the biosimilars market truly takes off in the US.