Generics
Zydus Cadila and Sandoz generics approvals in North America
In April 2021, Zydus Cadila received final approval from the US Food and Drug Administration to market its ibrutinib and macitentan generics. In addition, in May 2021, Sandoz Canada announced the launch of their pirfenidone, a generic version of F. Hoffmann-La Roche’s Esbriet®.
Difficult-to-make drugs meet US quality standards
Difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the country, finds a study published in JAMA Network Open [1].
New in vitro–in vivo simulations predict generic bioequivalence
If we can predict the outcome of bioequivalence studies in the generic drug development process, we can save time and money. Now, a new in vitro–in vivo simulation (IVIVS) approach to predict the in vivo outcome of these studies, published in Materials [1], has been developed by researchers National and Kapodistrian University of Athens.
EMA recommends approval of abiraterone and ioflupane (123I) generics
The European Medicines Agency’s (EMA) Committee for Medical Products for Human Use (CHMP) recommended granting marketing authorizations for two generic medicinal products at its April 2021 meeting.
Generics in India
India is the world’s largest generic drugs producer, yet the generics market within the country is relatively small. In a recent article [1], Sajid Sheikh and Gunjan Deshpande of the Maharashtra National Law University, Mumbai, explore the current status of generics in India.
Tentative US approval for Symbicort generic
On 8 March 2021, Viatris Inc and Kindeva Drug Delivery LP announced that the US Food and Drug Administration (FDA) has granted the tentative approval of their generic version of Symbicort® (budesonide/formoterol).
US$1.2 FDA contract for generic drug computational tool
The US Food and Drug Administration (FDA) Office of Generic Drugs (ODG) has awarded a US$1.2 million contract to support the development of a computational tool that will aid generic drug research.
Dispensing branded drugs costs Medicare over a billion dollars
Branded drugs dispensed instead of generics at the request of physicians and patients have incurred annual costs of over US$1 billion to the Medicare programme. and US$270 million to patients, reveals a study published in JAMA Network Open [1].
Technological approaches to drug repurposing for cancer treatment
Cancer is one of the leading causes of death in the world today, causing nearly 10 million deaths in 2018 alone. Despite extensive research into new treatments, when these eventually reach the market, they are often very expensive. The strategy of drug repurposing is being applied to identify already approved drug products as potential cancer therapies. This can bring new cancer treatments to patients faster and at a lower price. A review, published in Signal Transduction and Targeted Therapy [1], summarizes approaches used for drug repurposing and discusses the main barriers to uptake.
EMA recommends approval of abiraterone and thiotepa generics
In January and February 2021, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) held meetings that led to positive opinions towards the recommendation for approval of two generics, Abiraterone Accord (abiraterone) and Thiotepa Riemser (thiotepa).
