41-50 of 57 results
Assessment of biosimilars - Is Australia leading, following or going its own way?
The ongoing lack of certainty about what is required to obtain biosimilar registration in Australia extends to three key issues - Comparability is the new product sufficiently similar to permit it to rely on the reference products safety and efficacy data Extrapolation for which of the indications ...
Protecting investment in biologic medicines - biological medicines, biosimilars and the challenges they pose
This series of articles is directed towards the part of biotech that is pharmaceutical rather than diagnostic or bioengineering technologies and in particular towards biologic medicines ...
What's in a (biosimilar) name?
Because biosimilars and their reference biologic medicine are not identical whether compared to each other or even between biosimilars it is important to know which product has been used ...
Costs before Caution - Australia's unique approach to the interchangeability of biosimilars
Recent developments in Australia suggest that there has been a deliberate prioritisation of the cost benefits of facilitating biosimilar interchangeability over the safety and efficacy risks that can arise when biosimilars are used interchangeably ...
Discussion Paper: Biologic medicines and biosimilars in the Australian landscape - The challenges and the opportunities
Allens is engaging with stakeholders on the challenges and opportunities presented by biosimilars As part of this engagement we highlight a number of key issues for discussion and comment ...
Protecting innovation without patents - data exclusivity and market exclusivity
Developments in patent law and the consequential limitations on patentability for biologic medicines mean that data exclusivity and market exclusivity can be the primary protection afforded to originator biologic medicines This is most stark in the US where patent protection for biologic medicines ...
Special Report: Understanding the opportunities and navigating the legal frameworks of distributed ledger technology and blockchain
Authored by a multidisciplinary team from Allens Blockchain Reaction is designed to assist business stakeholders decision makers and in-house counsel across a variety of sectors to understand the technology and how it is being used as well as navigate the regulatory and legal opportunities and ...
Predictive coding: the future of electronic document production?
A recent decision of the English High Court may pave the way for the use of predictive coding in large scale discovery and regulatory investigations in Australia Partners Nick Rudge and Duncan Travis Managing Associate Kate Austin and Associate Emily Giblin look at the benefits and risks of the new ...
Patent examination guidelines in the wake of Myriad
Following public consultation on proposed examination guidelines issued on 16 October 2015 the Commissioner of Patents has established a revised examination practice taking into account the High Courts decision in emDArcy v Myriad Genetics Incem Dr Trevor Davies Partner at Allens Patent amp Trade ...
Government rejigs electronic health records system with opt-out approach
The Federal Governments electronic health records system may have a new lease on life following the introduction of a new Bill that attempts to improve the systems effectiveness with key changes such as the transition to an opt-out approach Partner Ian McGill Senior Associate Phil OSullivan and ...