Chart: Waxman Biosimilars Bill Adds Exclusivity, Tweaks Substitutability
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While biosimilars legislation is seen as a means of lowering health care costs, interchangeability provisions in House bills creating a biosimilars approval pathway would not be enough to allow automatic substitution at the pharmacy level - the route to the highest savings
Two versions of biosimilars legislation are now before the House, and the question is how much, if any, compromise will be needed to get a measure approved on that side of Capitol Hill
Any legislation creating a pathway for approving follow-on biologics will need to include a brand exclusivity period of less than 10 years, Teva North America CEO William Marth maintains