US Pharmacopeia

Since the first biosimilar was approved in the U.S. in 2015, more than 60 biosimilars have entered the market, collectively saving healthcare systems an estimated $36 billion. On this year’s Global Biosimilars Week, we are pleased to announce the release of a 2.0 infographic on biosimilars quality, which we developed jointly with the FDA to serve as a resource for healthcare practitioners to better inform patients about the quality attributes of FDA-approved biosimilar products. Originally launched in 2022, this resource was designed to spark dialogue that will enable acceptance and adoption of these therapies. With the expansion of biosimilars, patients now have more access to quality treatment options for chronic and serious conditions, including cancer, diabetes, arthritis, and other chronic diseases. For more information, view the infographic below and share for awareness! #GlobalBiosimilarsWeek

How does the quality of antimicrobial medicines around the world affect #AntimicrobialResistance in the United States? An often-overlooked cause of #AMR are substandard or falsified antimicrobial medicines. Approximately 1 in 10 medicines in low- and middle-income countries are substandard or falsified, according to the World Health Organization (WHO) with some estimates suggesting that 17% of the world’s antibiotic supply may be substandard or falsified. Since infectious diseases do not honor a country's borders, the emergence of #AMR in one part of the globe could be a threat anywhere. Scroll below to learn how poor-quality medicines contribute to this global #PublicHealth threat and visit: Bit.ly/AMAJoEfromUSP for more from USP’s policy expert Amy B. Cadwallader, PhD via AMA Journal of Ethics. Ready to join us in calling for action to #BeatAMR? Take a stand this World Antimicrobial Resistance Awareness Week | U.S. Antibiotic Awareness Week and help safeguard the resilient supply of quality antimicrobials. Here are three three policy and regulatory reforms to share with your network: ??Prioritize building resilience in the global antimicrobial supply chain, including by fostering broader geographic distribution and more sources of API production. ??Build capabilities among global stakeholders to reduce the proliferation of poor-quality antimicrobials. ??Incentivize research and development of the next generation of drug products while assuring the quality of existing antimicrobials. #WAAW2024 #USAAW24 #FightFakeMeds #AMRWeek

Edward Abwao, a technical advisor for the USAID-funded PQM+ program, presents a poster with data from the Pharmacy and Poisons Board on post-marketing surveillance of medicines in #Kenya at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting in New Orleans, Louisiana. Comment if you'd like to hear more insights from Edward and hit share to pass it on. #HealthSystems

Register today for our free eLearning course on Good Manufacturing Practices in a Control Laboratory Setting. This introductory course provides a foundation for further exploration and application of #GMP principles in quality control laboratories to ensure quality medicines. Learn more about the USAID-funded PQM+ resources available to pharmaceutical professionals here: https://ow.ly/yhVc50U8kpJ #HealthSystems

During World Antimicrobial Resistance Awareness Week, we are reminded of a critical reality: substandard medicines don’t just endanger individual patients; they also drive antimicrobial resistance, posing a global health threat. SF antibiotics not only fail to treat infections but actively accelerate antimicrobial resistance. Nearly 5 million people died in 2019 from causes associated with #AMR. Together with Fight the Fakes Alliance, Centers for Disease Control and Prevention, and others, we’re joining forces to promote awareness and action to help ensure safe, effective antimicrobial treatment for all. By making quality assurance a critical component of antimicrobial stewardship and collaborating to secure the global supply chain, we can help #BeatAMR and #FightFakeMeds. Hit #Repost to spread the word visit: Bit.ly/48yJHCj to learn more about advancing the quality of medicines to combat AMR. #WAAW2024

Consistent access to and availability of quality diagnostics & medicines is at the heart of effective tuberculosis (TB) treatment. To help countries transition from The Global Fund support for TB programs, the USAID-funded PQM+ program strengthened the capacity of national regulatory authorities and manufacturers in Uzbekistan, Kazakhstan & Tajikistan to secure an uninterrupted supply of quality-assured TB drugs by: ? Improving the regulatory environment and reducing registration delays ? Increasing national testing capacities ? Growing regional production of quality-assured TB medicines Learn more: https://ow.ly/CMBC50U704S

“There are no villains, just misaligned incentives. To ensure patients get the medicines they need when they need them, resilient supply chains must be economically viable.” ?? Vimala Raghavendran | US Pharmacopeia VP, Digital and Innovation Last week, Vimala joined fellow public health experts at Milken Institute’s Future of Health Summit to discuss the present and future of pharmaceutical supply chains. Moderated by Sarah Karlin-Smith, the panel featured Kirk Kaminsky (McKesson), Laura Bray (Angels for Change), and Shamiram Feinglass MD, MPH (Manatt, Phelps & Phillips, LLP). Click ? to watch this engaging conversation and hear more insights from panelists, including: ?? Low-margin generics are the “salt and pepper” of the healthcare industry, but manufacturers often can’t stay in business producing them. ?? Investment in workforce training only helps bring more API manufacturing to the US if the economics of the drug product are viable. ?? While individual hospitals and manufacturers know the status of their own supply chains and stockpiles, the system as a whole struggles to synchronize these dispersed knowledge bases. #MIHealthSummit #SupplyChain #PublicHealth

“The World Health Organization Prequalification of Swiss Pharma Nigeria Limited's SP tablet will go a long way in reaching tens of millions of pregnant women in Nigeria to prevent malaria, thanks to USAID and US Pharmacopeia support.” ?? Abbas Sambo | Swipha Business Development and Licensing Director Recently, with the support of USAID-funded PQM+ program, Nigeria-based manufacturer received prequalification for an essential medicine that prevents malaria in pregnant women and India-based Mepro Pharmaceuticals Pvt. Ltd. was approved for a product to treat intestinal parasites. USP is proud to have supported these manufacturers to attain WHO PQs and help expand the supply of safe, effective, and quality-assured medicines. Visit our newsroom to learn more about this win for patient safety: Ow.ly/ZJh250Tl0Jx #GlobalHealth #Africa #SupplyChain #QualityMonth

Meet Jane Weitzel, quality control expert, #USPExpertVolunteer, and Chair of the US Pharmacopeia Expert Committee for Measurement and Data Quality. During USP's 2020-2025 cycle, under Jane's leadership, her committee helped reduce the environmental impact of pharmaceutical manufacturing by working to develop, review, and revise public standards and solutions in collaboration with USP staff. For example, they developed USP General Chapter <1220> Analytical Procedure Life Cycle, which can help prevent errors, control variability, and reduce natural resource consumption in quality testing of medicines. Join us in celebrating champions of quality, like Jane, and visit Bit.ly/3UsLaEG to read more about USP commitment and ongoing efforts to build a healthier, more sustainable world. #WorldStandardsWeek #SupplyChain #Sustainability #Standards

Throughout the Pan American region, there is a strong tradition of using botanicals as herbal medicines and a growing desire for botanical dietary supplements. USP’s #qualitystandards play a critical role in ensuring the quality and safety of these products. Learn about the evolution of herbal medicines, their regulatory framework, and national quality and research initiatives in the Pan American region in a recent article by USP’s Pan American Botanical Dietary Supplements and Herbal Medicines Expert Panel: https://ow.ly/iwo850U1g8r