Abstract
Wow. West Virginia University has bought a 23-acre generic medicines manufacturing plant in the USA which employed 1400 workers for $1 from Viatris.
Most international pharmaceutical manufacturers have downsized their activities in Russia whilst maintaining their humanitarian responsibilities. HIV medicines have continued to be distributed in Russia but according to the FDA database, 251 clinical trials in Ukraine have been impacted.
The major API news has been the establishment of the Sanofi API company called Euroapi. This company is expected to be listed on the French stock exchange during the summer. Euroapi has six production sites in UK, France, Germany, Italy and Hungary with over 3000 employees and will be focussed on Contract Development and Manufacturing. Initially it will probably challenge the Chinese and Indian API companies but eventually it may just take business away from other Europe-based API manufacturers.
The fall in ANDA generic medicines approvals in the USA that was seen in 2020 has continued into 2021. A total of 631 final ANDA approvals were issued which is a 16% decline from 2020. In addition, 117 tentative approvals were issued in 2021 which is a decline of 5% on 2020.
The Indian generic companies ranked first with 42% of all USA ANDA approvals and the Chinese companies came in third with 10%. The leading Chinese company was Fosun Pharma (which acquired Gland Pharma in India). The USA generic companies ranked second between India and China with 31% of all ANDAs.
In other news, Philip Morris, the world’s largest tobacco seller, acquired Vectura in the UK that makes dry powder inhalers and nebulisers and Fertin Pharma in Denmark that makes gums and powders. There is speculation that the Marlboro cigarette manufacturer is evaluating the development of new cannabinoid and nicotine products.
Viatris and Biogen have downsized their biosimilars businesses with their divestments to Biocon and Samsung Bioepis. Is this a short-term re-focus or a long-term trend in the biosimilar segment?
In a positive step forward, the International Generic and Biosimilar Association (IGBA) has established a CEO Advisory Committee including most of the industry heavy weights. Of the 14 committee members, 5 are from India, 4 from Europe, 3 from North America and 2 from Japan/Israel.
Medicine Discovery is progressing well with around 6000 new products now in active development according to IQVIA. This has increased 68% over the last five years since 2016. Interestingly the rise in innovation is coming from the smaller players which account for 65% of this new product pipeline and is up from 50% five years ago. Indeed, in 2021 the FDA approved 50 novel medicines and most observers expect the same number in 2022 in-spite of all the lockdowns from the Covid pandemic. The same trend can be seen in generics with the renewed interest in speciality brands.
In this issue, we continue with our global footprint of manuscripts with contributions from Bulgaria, Ghana, UAE, India, France and the USA.