Also known as: United States Pharmacopoeia, USP
FDA draft biosimilar guidance released March 10, 2026 removes animal toxicology and immunogenicity requirements and accepts some non-U.S. comparator data. The changes are projected to cut development costs by up to 50%.
FDA said in early February 2026 that it is taking issue with “same active ingredient” claims in compounded drug advertising. The stance contrasts with longstanding agency frameworks for active ingredient sameness in generics and compounding.
South Africa is working to identify local manufacturers for lenacapavir, a twice-yearly injectable HIV prevention drug that showed near-perfect efficacy in clinical trials. Kenya has already received 21,000 doses of the medication.
The U.S. Pharmacopeia announces development of digital reference standards and digitally structured methods for pharmaceutical workflows, with formal recognition in USP–NF effective December 2025.
