Common use of Biosimilar Clause in Contracts

Biosimilar. A biological product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. Brand Name Drugs: Prescription Drug that has a current patent and is marketed and sold by limited sources, or is listed in widely accepted references as a Brand Name Drug based on manufacturer and price. Calendar Year: The period of 12 consecutive months that starts each January 1 at 12:01 a.m. and ends on the next December 31 at midnight. Chemical Dependency: A condition characterized by a physiological or psychological abuse of or dependency on alcohol or a controlled substance that is subject to regulation under Chapter 69.50 of the Revised Code of Washington, which is further characterized by frequent or intense patterns of pathological use to the extent that the user exhibits a loss of self-control over the amount and circumstances of use; develops symptoms of tolerance or physiological and/or psychological withdrawal if use is reduced or discontinued; and the user’s health is substantially impaired or endangered or his or her social or economic function is substantially disrupted. The following conditions are either not considered Chemical Dependency Conditions or are covered under other benefits offered by this plan (subject to all terms, limitations and exclusions): • Conditions related to Mental Health (see Mental Health Condition definition); • Nicotine Related Disorders (see the Tobacco Cessation benefit); and • Non substance related disorders Claim: Any request for a plan benefit made by you or your authorized representative. A subscriber or dependent making a Claim for benefits is a claimant. Coinsurance: Your share of the cost of a Covered Service, expressed as a percentage. Concurrent Claim: Any Claim that is reconsidered after an initial approval for ongoing treatment and results in a reduced or terminated benefit.