Policies & Legislation
US policy brief identifies barriers to biosimilars uptake
It was projected that by 2026, biosimilars could save up to US$150 billion in the specialty pharmaceuticals market. However, in the US, it has emerged that there are inherent barriers to market entry [1]. These obstruct greater biosimilar commercialization and uptake, making it difficult to achieve large healthcare savings that were hoped for. To date, the US Food and Drug Administration (FDA) has approved 26 biosimilars [2], yet most of these are not currently available to patients.
Genentech and Amgen settle biosimilar disputes
Genentech has reached a settlement agreement with Amgen over its biosimilars of Herceptin (trastuzumab) and Avastin (bevacizumab). All claims have been dismissed, allowing Amgen to continue marketing the biosimilars.
China publishes new patent law amendment
On 3 July 2020, China’s Standing Committee of the National People's Congress published a second draft amendment to its Patent Law. This introduces patent linkage, patent term extension and patent term adjustment. It expands on several provisions to improve protection for new drugs laid out in the first draft amendment published in 2019.
EMA and FDA agree new priorities, including research on COVID-19
At the 2020 bilateral regulatory dialogue meeting, senior officials from the European Commission, European Medicines Agency (EMA) and US Food and Drug Administration (FDA) identified new strategic priorities for medicines.
Judge rules in AbbVie’s favour over biosimilar delay deals
On 10 June 2020, a judge in Illinois dismissed a class action against AbbVie regarding its blockbuster arthritis biological, Humira (adalimumab).
NHS lawsuit against Servier Laboratories reaches Supreme Court
The UK National Health Service (NHS) has filed a GBP 220 million (US$280 million) lawsuit against the French pharmaceutical company Servier Laboratories. The Supreme Court has now agreed to hear the lawsuit, which relates to a patent used to block generic versions of a hypertension drug.
FDA to hold public meeting on its user fee programmes
The US Food and Drug Administration (FDA) is to hold a virtual public meeting to discuss the financial transparency and efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA).
Impact of upcoming regulatory changes on patent disputes in Australia
Following a series of proposed transparency reforms from the Australian Therapeutic Goods Administration (TGA), a recent commentary explains what the changes will mean for pharmaceutical patent disputes.
Australia’s regulatory body proposes transparency reforms
Australia’s Therapeutic Goods Administration (TGA) has issued a number of proposed transparency reforms for feedback from industry stakeholders, including earlier notification of generics applications.
COVID-19 brings new collaborations to Australia and the EU
In response to the COVID-19 pandemic, authorities in Australia and the European Union have allowed drug producers to collaborate to ensure medicine production and supply.
