The entrance of biosimilars in the U.S. market represents a significant shift in the pharmaceutical dynamics. Based on position in the market, biosimilars represent a channel for significant growth for some organizations while others defend their product’s market share against encroaching biosimilars. Downstream, the healthcare network prepares new strategies that account for impending biosimilar penetration.
Current conversations around biosimilar naming and payment models set the stage for developing products. Bringing a biosimilar to U.S. market presents a daunting task for manufacturers, as described by the CEO of a US-based biosimilar developer. He points out the Center for Medicare & Medicaid’s proposal, which treats biosimilars like generics for payment policy purposes, as an example of a challenge faced by manufacturers. In an effort to standardize the guidelines for the volume of launching biosimilars, the CMS proposal purposefully disregards clinical interchangeability and replacement. While the language of the regulation allows for CMS to segment out biosimilars in the future, the initial precedent could be difficult for some manufacturers to overcome.
As far as the more favorable biosimilar regulations for some manufacturers, the FDA offers a condensed pathway for the marketing of biosimilar products. Through this shortened process, the biosimilar manufacturer relies on clinical trial data from the original reference product to obtain approval. This route helps biosimilar manufacturers launch their lower-priced drugs at a more rapid pace. However, this pathway also provides the reference product’s manufacturer with an opportunity to defend its existing patents, as the recent news surrounding the Humira biosimilar reveals.
For providers downstream, the introduction of biosimilars has a significant impact on the way patients are treated for specific therapeutic areas. HCPs consider biosimilars much more like therapeutic alternatives, presenting additional challenges for provider and pharmacy communication. Many argue that the landscape becomes even more complicated with the FDA’s direction on biosimilar naming, which requires the use of unique, non-proprietary names for all biosimilar products.
Many payers are calling for a reality check with the optimistic view on how biosimilars relieve cost pressure on the nation’s healthcare system. With the goal of establishing the most appropriate coverage for patients, many payers currently invest significant resources in more thorough research around biosimilars and real-world utilization. Considering that HCPs prescribe and administer biosimilars, like Zarxio, in clinical settings, P&T committees actively discuss the maintenance of these products on the appropriate formularies.
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