Individuals living with MS pay between $16,500 to more than $30,000 a year for their medically necessary drugs. Generic (or follow-on) versions of biological therapies are not yet available in the United States for any condition because the Food and Drug Administration (FDA) does not have the authority to review applications for generic versions of biologic drugs like other counties do.
The cost of these drugs can keep them out of reach for those who need them. Congress must pass legislation to create a regulatory pathway to approve safe, effective and lower-cost generic versions of biological drugs. With Congress preparing to debate health care reform legislation this summer and affordability being one of the key components of legislation, now is the time to influence the reform debate.
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Click here to e-mail your senators and representative to urge them to include follow-on biologics legislation as a part of broader health care reform legislation.
Four of the six MS therapies are biologic drugs, which are drugs produced from living cell cultures rather than synthesized chemicals. Congress must pass legislation in order to create a regulatory pathway for approving safe and effective follow-on versions of biologic drugs. More affordable follow-on versions could provide safe alternative treatment options and help alleviate the cost burden on families living with MS and other diseases. Recent congressional testimony has shown that a competitive pathway for follow-on biologics will also help spur new innovation.