Australia’s competition authority has extended the arrangements allowing local off-patent industry body the GBMA to closely collaborate with brand organization Medicines Australia to co-ordinate supply against the backdrop of the ongoing COVID-19 pandemic.
Australian off-patent body the Generic and Biosimilar Medicines Association can continue to work closely with brand organization Medicines Australia to ensure supply of essential medicines amid the COVID-19 pandemic, after the Australian Competition and Consumer Commission granted a one-year extension to arrangements put in place earlier in 2020.
At the start of April, the ACCC granted a “conditional interim authorization” to allow the GBMA and Medicines Australia to...
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.
Generics Bulletin reviews global regulatory developments across the world.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?
Doubling down on the launch of its Stelara biosimilar Pyzchiva in Europe last year, Sandoz has just released an autoinjectable version of the drug, with the aim to offer a more convenient option for ustekinumab patients.
