Policies & Legislation

President Biden signs ‘Advancing Education on Biosimilars Act’

Home/Policies & Legislation | Posted 04/06/2021

US President Joe Biden has signed the Advancing Education on Biosimilars Act of 2021, authorizing the Food and Drug Administration (FDA) to educate patients and healthcare providers about the benefits of biosimilars. This follows the reintroduction of the Bolstering Innovative Option to Save Immediately on Medicines Act (BIOSIM Act), which will increase reimbursement for biosimilar drugs.

Teva under scrutiny in EU pay-for-delay investigation

Home/Policies & Legislation | Posted 31/05/2021

In March 2021, the European Commission opened a formal investigation into alleged anti-competitive – ‘pay-for-delay’ – conduct, by the Israeli generics giant Teva Pharmaceutical Industries (Teva).

EU and Brazil health authorities enter partnership

Home/Policies & Legislation | Posted 21/05/2021

Health regulatory authorities in the European Union (EU) and Brazil entered a partnership to ensure mutual recognition and regulatory harmonization to improve human and animal health.

Bills increase access to affordable drugs in the US and the Philippines

Home/Policies & Legislation | Posted 14/05/2021

In the opening months of 2021, a bill was proposed to make more biosimilars accessible to a greater proportion of the US state of Minnesota’s residents. In addition, a bill was passed in Wisconsin that will give pharmacists the ability to recommend cheaper drug options. And, in the Philippines, a bill has been filed to encourage the use of biosimilar drug products.

EU Court of Justice upholds Lundbeck fines over pay-for-delay

Home/Policies & Legislation | Posted 07/05/2021

On 25 April 2021, Danish drug company Lundbeck and four generic drugmakers lost their appeal against European Union antitrust fines of Euros 146 million (US$172 million), imposed in 2013.

Colorado to import drugs from Canada and beyond

Home/Policies & Legislation | Posted 30/04/2021

In 2019, a law was passed in the US state of Colorado to allow the import of prescription drugs from Canada. A bill to expand drug imports, and include those from additional nations, cleared at House committee on 7 April 2021. This hopes to see imports from additional countries like Australia, France and Japan.

Federal Court maintains decision on infliximab patent validity

Home/Policies & Legislation | Posted 23/04/2021

On 21 January 2021 and following appeal, the US Federal Court again found that the patent held by The Kennedy Trust for Rheumatology Research regarding the use of infliximab (Janssen’s Renicade) is valid and infringed by Hospira’s biosimilar, Inflectra.

Teva not liable in US due to FDCA implied preemption

Home/Policies & Legislation | Posted 16/04/2021

In early 2021, implied preemption related to the Federal Food, Drug and Cosmetic Act of 1938 (FDCA or the Act) has prevented generics manufacturer Teva Pharmaceuticals (Teva) from being held liable for three different failure-to-warn theories.

China improves generics injection consistency evaluation

Home/Policies & Legislation | Posted 09/04/2021

China’s National Medical Products Administration (NMPA) announced regulatory improvements to the generic injections’ quality and efficacy consistency evaluation in May 2020.

Italy simplifies over-the-counter generics price and reimbursement

Home/Policies & Legislation | Posted 26/03/2021

The Italian Drugs and Medicines Agency (Agenzia Italiana del Farmaco, AIFA) has simplified its price and reimbursement procedure for class C generic/biosimilar medicines. As of February 2021, generic/biosimilar versions of over-the-counter class C reference products will automatically be classified as class C products.

Australia launches new medicines road map and substitution policy

Home/Policies & Legislation | Posted 12/03/2021

The Australian Government has launched a Medicine-Medical Product Manufacturing Road Map and new legislation to support medicine substitutions.

Problems with the tiered pricing policy for generics in Korea

Home/Policies & Legislation | Posted 19/02/2021

In order to try to improve the quality of generics and ensure an efficient and competitive generics market, the Korean Ministry of Food and Drug Safety (MFDS) introduced a ‘tiered system’ to restructure the drug pricing for generics in July 2020. However, since its introduction the system has not gone without criticism.

EMA and EU medicines regulatory joint five-year strategy

Home/Policies & Legislation | Posted 29/01/2021

The Europeans Medicines Agency (EMA) and the European Union’s (EU) Heads of Medicines Agencies (HMA) have published their joint strategy to 2025: Protecting public health in a time of rapid change [1].

Biden vows to protect Obamacare and increase reliance on quality generics

Home/Policies & Legislation | Posted 20/11/2020

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

Home/Policies & Legislation | Posted 06/11/2020

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

Home/Policies & Legislation | Posted 30/10/2020

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

Home/Policies & Legislation | Posted 23/10/2020

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

Home/Policies & Legislation | Posted 09/10/2020

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

Home/Policies & Legislation | Posted 25/09/2020

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

Home/Policies & Legislation | Posted 18/09/2020

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.

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