Policies & Legislation
FDA invites comments on research into disclosure statements in prescription drug promotional materials
The US Food and Drug Administration (FDA) has published a notice soliciting comments on its research entitled ‘Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials’. The purpose of the research is to build on prior investigation into the role of disclosures in educating or correcting misunderstanding in the context of prescription drug promotion.
Brazil publishes pathway for accelerating innovation: the National Strategy of Intellectual Property
A draft of the National Strategy of Intellectual Property (ENPI) was published in the Brazilian Official Gazette Public Consultation #46/2020 on 10 August 2020. It was produced by a working group consisting of various public administration entities coordinated by the Interministerial Group on Intellectual Property (GIPI), which is presided over by the Ministry of Economy. The draft was made available for a 20-day period (which was then extended) for the public to review.
Inter partes review (IPR) is a non-judicial process for challenging patents established by US Congress in 2011. A recent legal review explains the importance of IPR for the generic and biosimilar drug industries .
The uptake of biosimilars in the US has been lower than projected. Researchers at the UNC Eshelman School of Pharmacy in the US, have published a policy brief that identifies the main barriers to biosimilars uptake in the US . The brief, prepared by Jefferson Pike Jr, also highlights proposed US policies that provide solutions.
Alexion Pharmaceuticals has reached a patent settlement with Amgen over Soliris (eculizumab), Alexion’s blockbuster antibody treatment for the blood disease paroxysmal nocturnal haemoglobinuria (PNH). The agreement prevents Amgen’s biosimilar version of Soliris from entering the US market until 2025.
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 . 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 , yet most of these are not currently available to patients.
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.
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.
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.
On 10 June 2020, a judge in Illinois dismissed a class action against AbbVie regarding its blockbuster arthritis biological, Humira (adalimumab).