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Policies & Legislation

Biden vows to protect Obamacare and increase reliance on quality generics

President-elect Joe Biden plans to protect and strengthen the Affordable Care Act, the public health insurance scheme passed in 2010 by then President Barack Obama. Over the last few years, the Affordable Care Act has been under relentless attack [1], and the US Supreme Court is currently considering a case attempting to strike down the law.

Changes to New Zealand law for quick access to COVID-19 vaccine

The global race for COVID-19 vaccines is on. New Zealand has allocated hundreds of millions of dollars in a bid to get quick access to a vaccine, once found. Although the actual sum has not yet been revealed, this is in addition to its NZ$37 million vaccination strategy. 

AbbVie accused of anticompetitive tactics to stop Humira biosimilars

Pharmaceutical manufacturer AbbVie faces another legal challenge related to anticompetitive tactics in the US. On 12 October 2020, the US Public Interest Research Group (US PIRG) filed an appeal accusing AbbVie of employing tactics that have delayed market entry of biosimilars.

China’s draft measures for patent linkage system

China’s National Intellectual Property Administration (CNIPA) and the National Medical Products Administration (NMPA) published draft measures entitled ‘Implementing measures for drug patent dispute early resolution mechanism (trial for implementation)’ on 11 September 2020. These outline further aspects of the patent linkage system that were presented in July’s proposed amendments to China’s patent law [1]. Public comments on these measures are due by 25 October 2020.

Mylan/Synthon win European patent ruling on generic Copaxone

Mylan and their development partner Synthon have won a European Patent Office (EPO) ruling related to the multiple sclerosis treatment Copaxone (glatiramer acetate).

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 and the generic drug industry

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 [1].

Solutions to US low biosimilars uptake

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 [1]. The brief, prepared by Jefferson Pike Jr, also highlights proposed US policies that provide solutions. 

Alexion delays Soliris biosimilar until 2025

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.

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