The U.S. Food and Drug Administration took another step to implement its Drug Competition Action Plan on June 18, 2019, by updating the information provided in the Paragraph IV Certifications List. The updated list will provide greater transparency regarding Paragraph IV certifications and potential exclusivities. That transparency will in turn lead to greater predictability for generic manufacturers regarding the potential timing of approval for their ANDAs and the potential degree of competition. The additional information will also give the public better insight into the status of generic regulatory exclusivities and the potential future availability of lower-cost generic alternatives for specific drug products.
Among the key aspects in the development of a biosimilar product for the U.S. market is taking advantage of formal meetings with the U.S. Food and Drug Administration to gain insight on moving a clinical development program for a proposed biosimilar product forward. Tracking meeting requests is also one way to measure the prospects for growth and health of the U.S. biosimilars industry. By that measure, the prospects for the U.S. biosimilars industry look bullish. This year, FDA revised its estimate for meeting requests upward by six respondents to Center for Drug Evaluation and Research (CDER) meeting requests, reflecting the industry’s confidence in the growth of biosimilar market share in the United States.
FDA’s upward projection is consistent with independent estimates of potential biosimilar cost savings in the United States. In 2014, Rand Corporation estimated biosimilar cost savings over the next decade to be $44 billion. By 2017, Rand Corporation estimated biosimilar cost savings over the next decade to be $54 billion. The increase in estimated cost savings is premised on biosimilars gaining in market share of biologics prescriptions. These signs are all pointing toward increased growth of the U.S. biosimilars industry.
Read the full text of this client Alert, including lists of what to have prepared for meeting requests and the actual meetings, on the Duane Morris LLP website.