Understanding biosimilars will be crucial for pharmacists as interchangeability comes into play.
The changing pharma landscape with biologic drugs and the emergence of biosimilars presents unique opportunities for pharmacists, but also raises new challenges as time goes on, according to a session presented on March 7 during the 2018 Fifteenth annual MHA Business Summit.
Session presenter David Farber, BA, JD, partner, King and Spalding, discussed several key factors regarding biosimilars, including recently approved products, important definitions, and debates surrounding the products.
Compared with traditional small molecule drugs, biologics and biosimilars are complicated, living molecules. Due to the complexity of development, the non-active components of the molecular structure for approved biologic products are poorly understood, which could lead to a number of adverse events, according to Farber.
A major difference between the products is that innovator biologics are subject to a biologics license application, whereas biosimilars have to go through the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) pathway.
In Europe, biosimilars have been around for 20 to 30 years; however, they have only recently emerged in the United States due to the lack of an approval pathway, Farber said. Before the BPCI Act, there was no approval or marketing pathway for these drugs, which prevented them from entering the market.
Pharmacists should be aware of the definition of interchangeability and how it may differ for branded and generic drugs. For a product to be interchangeable, it should be expected to produce the same clinical results as the reference product for each indication, according to the session.
“The interchangeable product is a copy, in the full sense, of this very complex molecule,” Farber said.
Thus far, the FDA has not approved any biosimilars as interchangeable with the reference product. Biosimilarity is a different standard compared with interchangeability, and the 2 are not synonymous, according to the session.
Pricing is also at the forefront of any conversation about biosimilars. Although biosimilars are launched at cost of up to 30% below the innovator product, brand manufacturers may offer discounts to ensure that a novel biosimilar does not impact sales.
However, Farber noted that there is not enough biosimilar competition for the brands yet to spark steep discounts, which can impact reimbursement and other rebate or discount opportunities.
Interestingly, biosimilars are not priced like generics, but are instead priced like innovator drugs. For example, the Centers for Medicare and Medicaid Services recognizes that each biosimilar is unique and reimburses nearly all of them as they would innovator products, according to Farber.
Into the future, Farber noted that there may be an increased push towards biosimilars by pharmacy benefit managers that are hoping to cash in on lower-cost drugs without sacrificing efficacy. Lastly, Farber discussed some legal implications of biosimilars and how interchangeability may impact pharmacists.
As pressure grows to switch patients to biosimilars, it is crucial for specialty pharmacists and home infusion providers to understand the differences of the drugs. There may be unexpected adverse events related to biosimilars and providers must be able to handle it, according to the session.
“Small changes in manufacturing process and different manufacturers may have a huge impact here, in this very large, complex molecule.” Farber said. “Pharmacy and pharmacist engagement in the whole biosimilar pipeline is hugely important.”