Overcoming the Constraints of Biosimilar Legislation through Creating Transparency

Biosimilar pharmaceuticals are new lower-cost drugs awaiting large-scale approval within the United States (U.S). Biosimilar pharmaceuticals or simply biosimilars, are complex, large-molecule, and biologically-derived drugs that are deemed molecularly similar to currently approved reference biologics. Biologics and biosimilars both treat a wide range of conditions with no clinically meaningful difference between them. However, numerous states, with help from large pharmaceutical companies lobbying, are passing legislation complicating the prescribing and dispensing process for biosimilars by mandating a "notification" or "communication" requirement. The notification requirement requires pharmacists to contact prescribers when dispensing an interchangeable biosimilar in place of its reference biologic. This type of mandate is not only unprecedented in current U.S. pharmaceutical law, but it also incentivizes pharmacists to dispense more expensive biologics in place of biosimilars. The notification or communication requirement also falsely gives consumers the appearance that biosimilars are more dangerous in comparison to other types of biological medicines. These two factors, pharmacist hesitation and consumer distrust, serve as barriers to successful biosimilar market entry. High research and development costs and forecasted poor sales inhibit biosimilar companies from making the investment in innovating new drugs. The lack of investment in research and development prevents new biosimilars from entering the market to compete with currently approved biologics. In turn, current biosimilar legislation is reducing pharmaceutical competition and increasing drug prices. Information Measurement Theory supports the notion that in climates without competition (caused by a lack of transparency) sparks low quality and high costs. Transparency and improved biosimilar market conditions can be achieved through repealing the large pharmaceutical company backed notification requirement.