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Biosimilars have the potential to increase patient access to important biological therapies and reduce healthcare costs by introducing competition in the marketplace.

The development of a biosimilar typically takes 5-10 years, significantly longer than the development of a generic small-molecule drug, which usually takes about 2 years.¹

Extrapolation is the approval of a biosimilar drug for an indication held by the reference drug without direct studies of the biosimilar in patients with that indication. Extrapolation leverages the totality of evidence (including robust analytical, nonclinical, and clinical data) to extend the approval of the biosimilar to other indications based on the comprehensive understanding gained from the scientific justification. Extrapolation is widely accepted by global regulatory agencies such as the FDA, the EMA, and the World Health Organization (WHO).²

Where needed, Teva is proactively designing support programs that offer guidance on access, affordability, and adherence, and, in some cases, copay assistance for eligible patients.

Interchangeability refers to the possibility of exchanging a reference biologic for a biosimilar that is expected to have the same clinical effect. Replacement can be done by the prescriber switching to the biosimilar or by substitution at the pharmacy level.

In the European Union, all biosimilars are considered interchangeable from a scientific point of view. In the United States, the FDA uses a scientific approach to determine if a switching study is necessary to demonstrate interchangeability for a biosimilar. In some cases comparative analytical and clinical data are sufficient to justify meeting the switching standard.^3,4

In the United States, biosimilar substitution must be authorized by a physician unless the biosimilar is designated as an interchangeable biosimilar, in which case the FDA does allow pharmacy-level automatic substitution of a biosimilar for a reference product. The regulations regarding automatic substitution vary among states.⁵

In the European Union, the substitution of a reference medicine for its biosimilar is not regulated by the EMA, and the decision-making authority is given to each national agency within the member states.⁶