On September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act.” According to FDA, the guidance…
Last week, FDA issued a notice of public meeting and request for comment relating to proposed recommendations for the reauthorization of the Biosimilar User Fee Act (“BsUFA”) for fiscal years 2023 to 2027. We have previously reported on BsUFA rates for the 2022 fiscal year. The BsUFA authorizes FDA to…
On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO) “pursuant to Executive Order 14036, and in the hope…
Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2022 fiscal year, which runs from October 1, 2021 through September 30, 2022. The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), which was signed into law on August 18, 2017….
As we previously reported, the “Consolidated Appropriations Act” enacted in December of last year contained a provision that required FDA to create a searchable, electronic database of biologics and to update it with patent information provided to an applicant during the patent dance. As of the effective date of June…
In honor of Women’s History Month, Big Molecule Watch will highlight the work of women who have contributed to the advancement of biologics and biosimilars. One such individual is Janet Woodcock, current acting Commissioner of the U.S. Food and Drug Administration (FDA) and director for Drug Evaluation and Research, who has held a number…
With the support of the economic development organization Invest Puerto Rico, Biosimilar Solutions LLC announced that both it and CytoImmune Therapeutics will be establishing operations on the island to conduct biologics and cell therapy research and development. According to the press release, CytoImmune will relocate to Toa Baja and plans…
The FDA has deferred its decision on the biologics license application for MYL-1402O, Mylan and Biocon’s biosimilar to Avastin® (bevacizumab). In a December 25th, 2020 company statement, Biocon cited the FDA’s need for more time to inspect the manufacturing facility. Such an inspection, which is a required step of the…
As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020. Please keep an eye out this week for posts identifying the most important regulatory, market, and legal developments impacting biosimilars. We start today with our picks for…
On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service Act for parenteral solutions to mean “total drug content,” without regard to concentration. Boehringer Ingelheim maintains that this correction would…