Tag Archives: Biosimilars

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
Senate Panel OKs FDA User Fees Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after the Memorial Day recess. The Senate HELP Committee approved the five-year renewal on a 21-2 vote. … Continue Reading

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
New Bill Targets Drug Prices Bipartisan legislation introduced in the Senate last week would require pharmaceutical manufacturers to alert the U.S. Department of Health and Human Services (HHS) before increasing prices more than 10 percent, continuing congressional pressure on the industry over drug pricing. The bill’s authors – including Sen. John McCain, (R-AZ) – say … Continue Reading

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for Brand-Name Biologics

Photo of Ron KernBy Rik Parker and Ron Kern on Posted in Uncategorized
On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar products may be brought to market. In Amgen Inc. v. Sandoz Inc. (Appeal No. 2015-1499), a divided panel of the Court of Appeals for the … Continue Reading

FDA Finalizes Guidance Documents on Biosimilars

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Nita Garg, Dena Kessler and Lindsay Holmes on Posted in Uncategorized
Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved biologics, the Food and Drug Administration (FDA) continues to issue guidance to clarify its interpretation of the law. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure … Continue Reading

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush and Lindsay Holmes on Posted in Uncategorized
On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the Medicare Part B, Part D, and Medicaid programs. This is an initial step for CMS, and more guidance is likely … Continue Reading

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for decades as a less expensive alternative to brand-name drugs and biosimilars have been available in Europe for several years. … Continue Reading
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