DeclutterPharma

FDA Works to Speed Up Biosimilar Development and Reduce Drug Prices The FDA has announced new measures to accelerate the development of biosimilar medicines, which are lower-cost alternatives to biologic drugs. These updates include simplifying biosimilarity studies and reducing unnecessary clinical testing, aiming to make it easier for biosimilars to be developed as interchangeable with brand-name biologics. Expensive biologic medications account for a significant portion of U.S. drug spending. While the FDA has approved 76 biosimilars, their market share remains below 20%. The new guidance reduces the resource-intensive requirement for developers to conduct comparative human clinical studies, allowing them to rely more on analytical testing. This is based on the FDA's data since the first biosimilar approval in 2015. The FDA aims to promote competition in markets dominated by high-cost biologics and provide additional treatment options for conditions like cancer, rheumatoid a...

The Directorate General of Health Services has issued a directive regarding the monitoring of high-risk solvents in the pharmaceutical supply chain due to recent reports of cough syrup contamination with DEG.  A Digital Monitoring System has been established on the ONDLS ( Online National Drugs Licensing System  )  portal for this purpose.  All state and UT drug controllers are requested to direct pharma-grade solvent manufacturers to obtain manufacturing licenses through the ONDLS portal. Manufacturers already holding licenses must register and submit data.  Solvent manufacturers must also upload batch details, including quantity and vendor information, to the ONDLS portal. Compliance with these directions is mandatory to ensure no non-compliant batches are available in the market. Table of High-Risk Solvents News from DrugsControl Media Services: Here The USFDA has also taken note of issues arising in India and published the following information on its websi...

General Information: Facility: Hetero Labs Limited, Unit-IX, located in Narasapuram Village, Andhra Pradesh, India. Inspection Dates: 09/19-26/2025. Type of Establishment: API (Active Pharmaceutical Ingredient) Manufacturer. Key Observations: 1. Unregistered Testing Laboratory: The facility used an unregistered testing laboratory for API testing, which was not referenced in their Drug Master Files (DMFs). This laboratory was located away from the main facility. Finished API samples with matching batch numbers and dates were discovered, indicating collaboration with the unregistered lab. The firm did not have a quality agreement established with this unregistered testing facility conducting analysis on products manufactured by your firm. Multiple examples of API intermediate samples were found at the unregistered testing laboratory. Numerous uncontrolled notebook pages containing analytical test results for APIs and API intermediates manufactured at this facility were found in the ...

The FDA announced a new pilot program to prioritise the review of abbreviated new drug applications (ANDAs). This initiative aims to encourage investment in U.S. drug manufacturing, research, and development, while also strengthening the domestic pharmaceutical supply chain. The program will offer faster reviews for generic companies that manufacture and test their products in the U.S. Currently, over half of the pharmaceuticals used in the U.S. are manufactured overseas, and the U.S. relies heavily on foreign sources for active pharmaceutical ingredients (APIs). As of 2025, only 9% of API manufacturers are in the U.S., while China and India account for 22% and 44%, respectively. Additionally, pivotal studies for drugs, including bioequivalence testing, are increasingly performed outside the U.S., which weakens the country's pharmaceutical infrastructure. The FDA's pilot program incentivises U.S. generic drug manufacturing and testing. ANDA applicants who conduct bioequival...