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To embed, copy and paste the code into your website or blog: 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 the most significant U.S. regulatory developments related to biosimilars in 2020: 1.FDA and FTC Announced Collaboration to Support Biosimilars Market In February, the U.S. Food and Drug Administration and the Federal Trade Commission released a joint statement signaling collaboration to advance competition in the market for biologic products. According to the FDA press release, “[t]his joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.” In ....
On Wednesday, December 16, 2020, the U.S. Fish & Wildlife Service (the Service) finalized for the first time a regulatory definition for the term “habitat,” as the term is used in the Endangered Species Act (ESA) and the various implementing regulations. See 85 Fed. Reg. 81,411 (Dec. 16, 2020). The definition becomes effective on January 15, 2021. We previously reported on the Service’s publication of the proposed definition, 85 Fed. Reg. 47,333 (Aug. 5, 2020). A link to the prior post on the proposed rulemaking can be found HERE. Background A keystone element of the Service’s protection of threatened or endangered species under the ESA is the designation, conservation, and protection of “critical habitat.” Section 3(5)(A) of the ESA defines “critical habitat” to include: ....