Abstract
The global generic industry continues to be focussed on changes in the USA marketplace.
The USA Department of Health and Human services (HHS) has cancelled over $0.5billion in funding for bird flu vaccines for humans. In addition, the USA has stopped funding GAVI, the global alliance that helps buy vaccines for the world’s poorest children. Robert F Kenedy Jnr (RFK) has dismissed all 17 members of the Advisory Committee on Immunization Practices (ACIP) at the Centres for Disease Control and Prevention (CDC) and has appointed 8 new members. The ACIP has guided US vaccine policy for the last 60 years and RFK has cited conflicts of interest owing to the pharmaceutical company relationships of previous members.
On USA medicine pricing, the Administrator for the Centers for Medicare & Medicaid Services (CMS), Mehmet Oz has been appointed to lead the USA drug pricing negotiations. Letters have been written to the CEOs of the 17 largest pharmaceutical companies asking them to reduce their medicine prices compared to those overseas. This is termed the “Most Favoured Nation” policy. The CEOs have been asked to take actions by the end of September 2025. The industry has also been warned that the planned USA tariffs on imported medicines could reach 250% over the next 18 months. This time period is designed to give pharmaceutical companies time to change their supply chains. This is quite an optimistic timetable in the light of the government regulatory challenges to make such changes.
Some generic companies have decided they “don’t fear the tariffs” others believe they are “manageable”. Some generic companies are reducing their global manufacturing foot print for example, from 35 to 30 facilities. Others have acquired manufacturing assets in the USA including both generic pharmaceutical companies and discovery pharmaceutical companies from around the world.
In the meantime, the top Indian 15 companies have continued to expand their USA sales at an annual growth of 6% (on a trailing 3 months basis). The number of FDA inspections of Indian factories has continued at around 250 inspections per year. However, the level of feared OAI (Official Action Indicated) inspection reports which often lead to closures is now at its lowest level since 2012. Other generic companies are focussing on their USA speciality products which in some companies have now reached a total sales volume of more than $1billion.
The generic industry is now excited by the next generic blockbuster – semaglutide the weight loss product. Next year in 2026 there are 87 countries where the semaglutide patent expires. The largest generic markets are Canada, Brazil and China (as these 87 countries exclude the USA and Europe). Even so, some observers see this as a $10 billion opportunity for formulations with a $1 billion API sales potential.
In the first quarter of 2025 there was a +44% surge in the number of Drug Master Files (DMFs) approved by the FDA. These are the USA regulatory licences for active pharmaceutical ingredients (API). The Indian API companies still dominate with a 48% share of all DMFs approved by the FDA.
In this issue, we continue with our global footprint of manuscripts with contributions from Austria, India, UK and Nepal.