WASHINGTON A new report by Datamonitor chastises the United States' inability to approve biosimilars the way the European Union has.
The Datamonitor report, entitled "Biosimilars: Regulatory Issues," indicates that Europe has progressively expanded its biosimilar market after it laid out the legal ground for the approval of generic versions of biologic drugs. The United States, however, has had several setbacks because it is unable to make a decision on the development and use of the generic drugs.
A total of five biosimilars have been approved in the European Union so far.
“In the United States, political issues and the tug-of-war between innovators and generic companies have delayed the formulation of legislation regarding regulatory approval of biosimilars, and the FDA has been reluctant to issue any guidance,” Datamonitor senior pharmaceutical analyst and report author Dr Tijana Ignjatovic said.
Ignjatovic did point out that three different bills were proposed in the United States because the “increasing expenditure on biologicsS has spurred lawmakers into action.”
In February, the Access to Life-Saving Medicine Act was introduced into Congress. Two months later, Congress was given the proposal of the Patent Protection and Innovative Biologic Medicine Act. Both of these bills have not made any progress, standing on the opposite ends of the spectrum: the former being pro-biosimilar and the latter being pro-innovator. By June, a compromise was reached with the introduction of the Biologics Price Competition and Innovation Act, Ignjatovic said.
“It proposes 12 years of market exclusivity for the patent holders but also one year of exclusivity to the first biosimilar to be approved as interchangeable with the reference product,” she said.
The Datamonitor report claimed the bill was controversial because while the market may become very profitable, smaller biotechnology companies may avoid entering the market. Meanwhile, the innovators and the generics industry can not agree on the 12 years of market exclusivity clause, with one thinking it was too long and the other, too short.
Since biogenerics are made in living organisms and their manufacturing processes are considered trade secrets, generic versions of biologics cannot be kept identical to their reference products and are effectively not “true generics” and need to be treated differently from generics of small molecule drugs, the report noted.