On June 4, 2018, FDA announced the availability of a new draft guidance on formal meetings with FDA concerning the development and review of biosimilar or interchangeable biological products. The draft guidance, titled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products,” is available here. FDA also…
Today, the U.S. FDA announced that it has approved Mylan’s aBLA for Fulphila™ (pegfilgrastim-jmdb), a biosimilar of Amgen’s Neulasta®. This approval marks the eleventh FDA licensure of a biosimilar product under the BPCIA regulatory scheme, following last month’s approval of Pfizer’s Retacrit™ (epoetin alfa-epbx), and the first time the…
For certain drugs with serious risks, the FDA may require drug developers to submit a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biologic outweigh its risks. For an overview on REMS click here. We have previously reported that FDA received numerous inquiries from generic…
Below are some recent regulatory developments in the biologics space. As we previously reported, USP has been considering a revision to the naming conventions for the titles of biologics product monographs. Following comments from FDA, USP announced that it would not make any changes absent stakeholder consensus. Last month, USP…
As we reported earlier this month, Coherus BioSciences recently resubmitted its application for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim), in response to a Complete Response Letter that it received from the FDA last June. Yesterday, Coherus announced that the FDA has accepted its pegfilgrastim resubmission and that the FDA considered…
For just the tenth time since the implementation of the BPCIA, the FDA has approved a biosimilar product. Today, the FDA announced that it has approved Pfizer-subsidiary Hospira’s Retacrit™ (epoetin alfa-epbx) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV…
Yesterday, Sandoz announced that the FDA has issued a Complete Response Letter (CRL) regarding its aBLA for its proposed biosimilar of Rituxan® (rituximab). Sandoz states that it “stands behind the evidence that it submitted to the FDA and that, “[w]hile disappointed, Sandoz remains committed to further discussions with FDA in…
Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans “communicate the anticipated financial positions of the Biosimilar User Fee Amendments of 2017 (BsUFA II), the Generic Drug User…
USP stated last week that it will not develop new product-specific monographs for biologics without stakeholder consensus in supporting their creation, including the support of FDA. USP had proposed revisions for these monographs in which “the official title shall be the title specified in the relevant monograph plus any suffix…
At CNBC’s Healthy Returns conference last week, FDA commissioner Scott Gottlieb discussed plans to encourage competition and speed approval of biosimilars. His comments largely tracked a statement that he made in early March. Gottlieb again criticized arrangements between distributors, pharmacy benefit managers, and health plans, which he views as restricting market access. …