Biosimilars Applications to Increase in FY16

There is escalating concern at the FDA for an increasing number of Biosimilar applications in the coming year. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told members of the U.S. House Energy and Commerce Committee’s health subcommittee she is concerned about the agency’s ability to manage what she expects will be an increasing number of biosimilars applications. “What I’m concerned about is that this program is going to explode,” said Woodcock. “I’m concerned that we will not have the staff because we’re always waiting to catch up.” The number of meeting requests for Biosimilars has increased from 32 in FY13 to 58 in FY15. The Full-Time Equivalent expenditure for the first two quarters of FY15 has already surpassed the total spending of FY14. Sean Cavanaugh, who is deputy administrator and director of CMS’s Center of Medicare, also testified at the hearing. Members of the health subcommittee questioned Cavanaugh at length about the agency’s coding and billing policy for biosimilars. With so much confusion about how Biosimilars should be coded and reimbursed, ReimbursementCodes continues to monitor CMS to ensure coding and reimbursement accuracy. Our database currently includes coding and pricing information for the first approved biosimilar Zarxio™. ReimbursementCodes will also include complete updates related to coding and reimbursement for all subsequently approved Biosimilars. Read the full article: Email to learn more about how ReimbursementCodes can keep you up to date with all incoming Biosimilars. And don’t forget to sign up for our next Biosimilars Webinar on Wednesday, February 17th at 2 PM (EST). ZARXIO is a trademark of Novartis AG.