India’s Central Drugs Standard Control Organization (CDSCO) implemented the New Drugs and Clinical Trials Rules in 2019 to expedite the drug development and approval processes. This article provides an overview of those processes; explains the rule-specific terminology, such as the definitions of “drug” and “new drug” under Indian law; and outlines strategies for speeding up the approval processes and optimizing registration of prescription medicines in India.   Keywo...

An official with the US Food and Drug Administration (FDA) announced the agency will soon resume unannounced onsite inspections in India and China. Also, prioritized foreign inspections will resume in February.   Elizabeth Miller, assistant commissioner for medical products and tobacco operations in FDA’s Office of Regulatory Affairs (ORA), provided this update on the agency’s inspection activities at a 9 December virtual conference on enforcement sponsored by the Fo...

A top official from the US Food and Drug Administration (FDA) offered a mixed assessment of the agency’s biosimilars program, noting that although the program is growing, there is more uptake of the program in the oncology space, with less activity in other treatment areas. The costly and lengthy process of getting biosimilars approved is also a deterrent to wider uptake.   Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation...

The lack of mature quality data, such as sufficient batch data, hindered the ability of the European Medicines Agency (EMA) to provide scientific advice to sponsors on their biosimilar development programs, according to a report on the agency’s recently concluded biosimilar scientific advice pilot.   Also, EMA found that current regulatory guidelines, which assume that developers will take a stepwise approach to biosimilar development where clinical studies are condu...

An anti-inflammatory biosimilar from Boehringer-Ingelheim has received interchangeability designation from the US Food and Drug Administration (FDA).        Cyltezo (adalimumab-adbm) is now both biosimilar to and interchangeable with Abbvie’s Humira (adalimumab), announced FDA, which had granted biosimilar status to Cyltezo in 2017. Cyltezo is approved for all indications for which Humira can be used, including several inflammatory arthritides, Crohn’s disease and ulce...

The US should look to the French healthcare system for lessons in reducing biosimilar pricing, according to a recent paper published in Health Affairs .   James C. Robinson, of the Division of Health Policy and Management, School of Public Health at the University of California Berkeley, and colleagues said the US “lacks consistent incentives for physicians to prescribe low-price biosimilars and for manufacturers to compete using price reductions” and that the slow up...

Medicare Part D plans are slow to adopt generic medications for their beneficiaries, according to a recent report released by the Association for Accessible Medicines (AAM).   For the 2021 plan year, Medicare Part D formularies covered 21% of approved first generic medications from the previous year compared with the 66% covered by commercial formulary plans, the report stated. But this is part of a years-long trend, according to AAM. Not only do Medicare Part D plans ...

In the latest round of negotiations between the US Food and Drug Administration (FDA) and the pharmaceutical industry on the reauthorization of the Biosimilar User Fee Amendments (BsUFA), the two sides reached common ground on several topics, including supplements and labeling for product safety updates, meeting management and application review practices.   FDA and industry began negotiations on the third BsUFA program in March following a public kickoff meeting las...

Experts expect to see a second wave of biosimilar approvals, though continued Medicare Part D reimbursement challenges hobble uptake, according to presenters discussing the current landscape and future projections for the biosimilars market at the annual meeting of the Association for Accessible Medicines (AAM) on 27 May.   “We have come a long way in the last two years,” said Craig Burton, vice-president of policy for AAM. Where you used to see one or two biosimilar p...

Janet Woodcock, the acting commissioner of the US Food and Drug Administration (FDA), says there has been a “significant increase” in biosimilars approvals as the pharmaceutical industry has shown renewed interest in developing these drugs.   The agency has also met some of the “key deliverables” of its 2018  Biosimilars Action Plan  to develop a more competitive market for these products, said Woodcock, who gave the keynote address at the annual meeting of the Associa...

The Vietnamese health ministry has met with the World Health Organization (WHO) to discuss the transfer of the technology needed to manufacture mRNA vaccines in the country.   Vietnam received a shipment of 811,200 doses of the COVID-19 vaccine developed by AstraZeneca and the University of Oxford via the COVAX Facility at the start of last month. Around 900,000 people have now received a vaccine, but the supply of doses remains a constraint on the pace of the rollou...

The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March.   During the two meetings, FDA and industry discussed issues related to application reviews, information technology, finance and staffing, regulatory science, review timelines and product safety updates. (RELATED: FDA, Industry set priorities for BsUFA III , R...