Healthcare professionals’ trust in biosimilars is key to ensuring their availability
Given the high cost and sharply increased use of biologics in recent years, the approval pathway for biosimilars echoes a phenomenon first introduced for generic drugs 40 years ago
Since the simplest forms of biologics (blood products and vaccines) entered the US market in the 1970s, followed by recombinant human insulin in 1982, and the first FDA-approved monoclonal antibody in 1997, biologics have transformed the treatment of serious medical conditions, but have also sharply increased the overall healthcare cost curve.
In 2009, the Biologic Price Competition and Innovation (BPCI) Act was passed to create an avenue for abbreviated FDA licensure pathways for biosimilars, and thereby enable developers to bring them to market at the lowest viable cost. The first biosimilar, filgrastim-sndz, was approved in the USA in 2015 and was quickly followed by many more approvals of biosimilars for an array of medical conditions.
Biosimilars are manufactured following reverse-engineering – by starting with the final therapeutic protein and working the synthesis steps backwards. Like all biologics, biosimilars are created in living systems (cell lines), and therefore are not exact copies of their reference product, although they are required to have the same amino acid sequence. During the development and approval process, their small molecular differences must be demonstrated not to impact efficacy and safety (i.e. not to be ‘clinically meaningful’). Because of this, the approval pathway for biosimilars is largely focused on analytical studies of their physical characteristics relative to the originator product, albeit supplemented with clinical evaluation.
Biosimilars are not granted patent exclusivity – several biosimilar versions of the same reference product may be available to purchase. For example, there are six FDA-approved biosimilars of trastuzumab. As more of these products enter the market, there will be increasing need for healthcare providers to gain trust in their efficacy and safety. With ever-rising healthcare costs and biologics occupying the most expensive drug category, the advent of high-value biosimilars may serve as a release valve to otherwise unsustainable markets. Healthcare professionals need to stay committed to evaluating biosimilar evidence to make these treatment options available.
Biosimilars are not granted exclusivity on approval and there may be several biosimilars for a single biologic. Healthcare providers need to gain trust in the efficacy and safety of each biosimilar that is marketed; although greater numbers of high-value biosimilars will help reduce overall healthcare costs.