Policies & Legislation

DIGEMID’s 45-day auto-approvals trigger safety warning

Home/Policies & Legislation | Posted 30/06/2025

Peru’s new regulation allows automatic drug approval if DIGEMID (DIGEMID (General Directorate of Medicines, Supplies, and Drugs, Dirección General de Medicamentos, Insumos y Drogas) does not respond within 45 days, raising concerns about compromised safety controls. Critics warn it may permit substandard medicines, especially biologicals and biosimilars, without proper evaluation, endangering public health. Stakeholders urge revisions.

ANVISA and Danish Medicines Agency renew health regulatory collaboration

Home/Policies & Legislation | Posted 06/05/2025

ANVISA, Brazil’s Health Regulatory Agency, and the Danish Medicines Agency (DKMA) have renewed their collaboration for another three years (April 2025–March 2028). This partnership, established in 2016, aims to enhance public health and regulatory practices through knowledge exchange and joint initiatives.

Colombia and Brazil introduce reforms to enhance healthcare regulation

Home/Policies & Legislation | Posted 22/04/2025

Colombia and Brazil have introduced reforms aimed at improving efficiency and transparency in their health sectors, marking a significant step forward toward enhancing healthcare regulation and accelerating access to medical products and clinical trials.

Second wave of drugs selected for Medicare price negotiation

Home/Policies & Legislation | Posted 11/04/2025

In January 2025, the US Department for Health and Human Security (HHS) announced the addition of 15 more Medicare Part D drugs selected for price negotiations.

NPRA Malaysia trials new timelines for variation applications

Home/Policies & Legislation | Posted 05/11/2024

In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications of registered pharmaceutical products and natural health supplements (TMHS).

Regulatory evolution and impact of simplified requirements for interchangeable biosimilars in the US

Home/Policies & Legislation | Posted 18/09/2024

This article examines the evolving regulatory landscape for simplified requirements for interchangeable biosimilars in the US. It explores recent US Food and Drug Administration (FDA) approvals, the role of switching studies, and updated labelling guidance, highlighting key changes and their implications for biosimilar development and use.

China’s NMPA expands global ties with the Netherlands and Indonesia

Home/Policies & Legislation | Posted 04/09/2024

China’s National Medical Products Administration (NMPA) has met with leaders from the Netherlands and Indonesia to discuss potential collaborations with these countries.

Japan's PMDA expands influence with new office in Thailand

Home/Policies & Legislation | Posted 06/08/2024

On 1 July 2024, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) announced the establishment of its first overseas office, the PMDA Asia office. This office is now open in Bangkok, Thailand, and is headed by Dr Kitahara Jun.

Panama embraces international pharmacovigilance standards

Home/Policies & Legislation | Posted 09/07/2024

Panama is implementing internationally standardized reporting codes for pharmacovigilance by adopting WHODrug Global and MedDRA dictionaries, following the example of several other Latin American and Caribbean countries.

FDA proposal to remove biosimilar interchangeability status in FY25

Home/Policies & Legislation | Posted 12/06/2024

In a major shift in regulatory policy, the US Food and Drug Administration (FDA) is calling on Congress to remove the interchangeability designation that has historically set biosimilars apart in the US market. Backed by the Biden administration, the FDA's new proposal would permit pharmacy-level substitution of biosimilar drugs for reference products without clinician recommendation. This would extend to all approved biosimilars, regardless of their interchangeability status.

MHRA unveils strategy for regulating AI technologies

Home/Policies & Legislation | Posted 22/05/2024

In April 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a policy paper on its strategic approach to artificial intelligence (AI) [1]. It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023 [2] and is the agency’s response to the Secretary of State letter of 1 February 2024 [3].

Regulatory Certainty Strategy for biosimilars launched in Mexico

Home/Policies & Legislation | Posted 09/04/2024

In February 2024, Mexico’s COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) announced the ‘Estrategia de Certidumbre Regulatoria’ – Regulatory Certainty Strategy (RCS) – for biosimilars.

Strategic plans of ANVISA and COFEPRIS to advance health regulation

Home/Policies & Legislation | Posted 11/03/2024

ANVISA and COFEPRIS, Brazilian and Mexican health regulatory agencies respectively, unveil strategic plans for 2024-2027. ANVISA prioritizes World Health Organization (WHO) recognition, identification of medicinal products (IDMP) standards adoption, and biosimilar drug development. COFEPRIS focuses on regulatory certainty, digitalization, and aligning with global manufacturing standards.

Panama enacts new bill to guarantees the supply of medicines

Home/Policies & Legislation | Posted 29/02/2024

On 18 January 2024, the National Assembly (AN-Panamanian Parliament) approved in the third debate Bill 1007, which regulates medicines, supplies, devices, and other products for human health, their public acquisition, and other provisions were enacted.

Advances in the availability of innovative medicines in Mexico

Home/Policies & Legislation | Posted 31/10/2023

A legal modification has recently been achieved for the faster recognition and release of innovative medicines on the Mexican market.

Nomenclature of biologicals and biocomparables in Mexico

Home/Policies & Legislation | Posted 18/03/2022

Following the articles on the management and implementation of the nomenclature of biological and biosimilar medicines in Brazil and Argentina based on the study by Iglesias Galiano M. 2021, this article will provide a summary of the same in Mexico.

EMA concept paper towards a tailored clinical approach in biosimilar development

Home/Policies & Legislation | Posted 09/02/2024

In November 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) published a 'Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development'.

Public consultation for the modification of the biosimilars regulation in Brazil

Home/Policies & Legislation | Posted 16/01/2024

The Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) initiated a public consultation on expediting regulation of biosimilar drugs. The goal is to decrease dependence on high-cost imported biological medicines and position Brazil as a significant regional exporter of lower-cost biological therapies.

COFEPRIS promotes regulatory cooperation in the Americas

Home/Policies & Legislation | Posted 12/12/2023

During the 60th Executive Council of the Pan American Health Organization (PAHO) held in Washington, DC, USA, on 25–28 September 2023, Alejandro Svarch Pérez, Head of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), on behalf of the Mexican government, emphasized the need to strengthen healthcare systems based on primary care.

CMS proposes allowing Part D plans to switch biologicals to non-interchangeable biosimilars

Home/Policies & Legislation | Posted 21/11/2023

On 6 November 2023, the U.S. Centers for Medicare & Medicaid Services (CMS) proposed a new rule to give Medicare Part D plans more flexibility. It has been proposed that biosimilars can now be substituted for the reference biologicals, even if these have not been deemed interchangeable by the US Food and Drug Administration (FDA).

ANVISA's decision on 'Skinny labels' for generics pending

Home/Policies & Legislation | Posted 14/11/2023

The Brazilian health regulatory agency, ANVISA (Agência Nacional de Vigilância Sanitária), is still considering whether to allow generic drug labelling to omit indications of the originator product that are still under patent.

More drugmakers sue over IRA yet one withdraws

Home/Policies & Legislation | Posted 09/10/2023

In the United States, Boehringer and Novartis join other drugmakers [1] in suing the US government over drug price negotiations in the Inflation Reduction Act (IRA). However, Japan-based Astellas Pharma withdrew its lawsuit filed against the US government in early September 2023.

First drugs for Medicare price negotiation selected

Home/Policies & Legislation | Posted 22/09/2023

The US Department for Health and Human Security (HSS) has selected the first drugs for Medicare price negotiation.

Updated Biosimilar Red Tape Elimination Act introduced by Senator Lee

Home/Policies & Legislation | Posted 24/08/2023

US Republican Senator for Utah, Mike Lee, has introduced an updated ‘Biosimilar Red Tape Elimination Act.’

Inflation Reduction Act explained

Home/Policies & Legislation | Posted 24/07/2023

The US Assistant Secretary for Planning and Evaluation’s (ASPE) ‘Medicare Part B drugs: trends in spending and utilization 2008-2021’ was published in June 2023 [1]. This outlines aspects of the Inflation Reduction Act (IRA) which is designed to address the rapid rate of increase in Part B drug spending and lower costs for Medicare enrollees.

AMLAC: regulatory agency for medicines in Latin America and the Caribbean established

Home/Policies & Legislation | Posted 13/06/2023

AMLAC, a regional body for Latin America and the Caribbean, is being set-up to promote greater access to safe, effective medical equipment and medicines through a combination of regional regulations.

Pros and cons of tenders for generics and biosimilars

Home/Policies & Legislation | Posted 06/06/2023

An editorial entitled ‘Tenders for Generics and Biosimilars: A Challenging Purchasing Policy’ has been published in the European Journal of Health Economics [1]. It is authored by Fernando Antoñanzas, Carmelo Juárez-Castelló, and Roberto Rodríguez-Ibeas from the University of Rioja in Spain and discusses the challenges associated with the implementation of tendering processes for generics and biosimilars in healthcare purchasing policies.

Medicare drug price negotiation: what next?

Home/Policies & Legislation | Posted 30/05/2023

A commentary published in Value in Health by Dr Sean D Sullivan of the University of Washington School of Pharmacy offers insights into Medicare drug price negotiation [1]. The commentary discusses the implications of negotiation [2] and asks the question, ‘what next?’

Medicare drug price negotiation: implications

Home/Policies & Legislation | Posted 04/05/2023

In 2022, The Inflation Reduction Act (IRA) was signed into law in the US. This sets out to empower the US Secretary of Health and Human Services (HHS) to develop and implement methods and a process to negotiate a limited number of prescription drug prices in the Medicare programme directly with manufacturers [1]. A commentary by Dr Sean D Sullivan of the University of Washington School of Pharmacy, published in Value in Health, offers insights into the implications of Medicare drug price negotiation [2].

New guidance for Medicare Drug Price Negotiation Program

Home/Policies & Legislation | Posted 20/04/2023

The Centers for Medicare and Medicaid Services (CMS) released a memorandum that acts as a new guidance for the Medicare Drug Price Negotiation Program [1].

FDA and FTC join forces to promote competition in the biological market

Home/Policies & Legislation | Posted 14/04/2023

The Federal Trade Commission (FTC) and the US Food Drug Administration (FDA) are collaborating to promote market competition for biological drugs, including biosimilars and interchangeable biosimilars, which will help increase access to safe, effective and affordable treatments for patients.

EU and Latin America/Caribbean launch virtual marketplace for pharmaceuticals

Home/Policies & Legislation | Posted 31/03/2023

Under the Global Gateway umbrella, the EU and Latin America and the Caribbean (EU-LAC) are partnering on health resilience and vaccine production, and as part of this effort, they organized a high-level pharma forum and matchmaking event – the European Union - Latin America and Caribbean Summit – from February to April 2023.

The effects of regulation on innovation in Mexican pharmaceutical industry

Home/Policies & Legislation | Posted 09/03/2023

This article analysed the effect of regulation on the innovation processes in the pharmaceutical industry. The research was exploratory in nature and the design used was a case study, corresponding to the development of a new medication for treating diabetes by a Mexican pharmaceutical company [1].

FDA publishes BsUFA III research roadmap

Home/Policies & Legislation | Posted 03/03/2023

In early 2023, the United States Food and Drug Administration (FDA) published their Biosimilar User Fee Act (BsUFA) III research roadmap [1] as part of their regulatory research pilot programme [2].

The US Biologics Competition Act and Biosimilar Red Tape Elimination Act

Home/Policies & Legislation | Posted 27/01/2023

The US introduced the Biologics Competition Act of 2022 (HR 887) in September 2022. This was followed by the introduction of the Biosimilar Red Tape Elimination Act in November 2022. Both acts seek to make biosimilar products more accessible and increase their uptake in the US.

EU public consultation on revised framework for compulsory licensing of patents

Home/Policies & Legislation | Posted 25/11/2022

The European Commission had opened a public consultation on ‘Intellectual property (IP) – revised framework for compulsory licensing of patents’. This was opened from 7 July 2022 to 29 September 2022.

Canada upholds decision to approve biosimilars where reference product is not marketed

Home/Policies & Legislation | Posted 30/09/2022

In court proceedings that concluded in August 2022, the Canadian Federal Court dismissed applications for judicial review put forward by AbbVie regarding the approval and marketing authorization of JAMP Pharma's Simlandi (adalimumab) product [1]. This confirms that Notice of Compliance (NOC) regulations do not apply to biosimilars when reference products are not marketed in Canada.

PDUFA VI: FDA could promote generics competition

Home/Policies & Legislation | Posted 29/07/2022

In the US, the current Prescription Drug User Fee Act (PDUFA) is due to expire in September 2022. A recent report calls for the new iteration of the act (VI) to increase Food and Drug Administration’s (FDA) authority to promote generic competition [1].

House bill passes FDA funding fees but conflicts with Senate bill

Home/Policies & Legislation | Posted 15/07/2022

In the Unites States (US), the House of Representatives voted to pass legislation to reauthorize the fees that help fund the US Food and Drug Administration (FDA). However, there are some conflicts between the House and parallel Senate bill that need to be overcome before either can be passed.

US Senate clarifies status of interchangeable biosimilar exclusivity

Home/Policies & Legislation | Posted 27/05/2022

The United States (US) Senate Health, Education, Labor and Pensions (HELP) Committee released a draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA) on 17 May 2022.

Nomenclature of biologicals and biosimilars in Peru

Home/Policies & Legislation | Posted 20/05/2022

This article, the last in a series on the nomenclature of biological and biosimilar medicines in various Latin American countries based on the study by Iglesias Galiano M in 2021, analyses the management and implementation of the nomenclature of biological and biosimilar medicines in Peru [1].

United States legislation to improve access to insulin

Home/Policies & Legislation | Posted 29/04/2022

In the US, a bill was passed in late March 2022 to cap the monthly cost of insulin at US$35 for insured patients. In addition, in early April 2022, a bipartisan bill to reform the US Food and Drug Administration (FDA) review and approval process for complex generics/biosimilars was passed.

Nomenclature of biologicals and biosimilars in Chile

Home/Policies & Legislation | Posted 22/04/2022

Continuing with the series of articles on the management and implementation of the nomenclature of biological and biosimilar medicines in Brazil, Argentina, Mexico and Colombia, based on the publication of an extensive study carried out in Peru by Iglesias Galiano M in 2021, this article will provide a summary focused on Chile [1].

Nomenclature of biologicals and biosimilars in Colombia

Home/Policies & Legislation | Posted 08/04/2022

This article analyses the realities of Colombia as part as a broader study carried out by Iglesias Galiano M, focused on some reference countries as well as those countries of the region with level IV according to Pan American Health Organization (PAHO) classification, which have implemented guidelines for the authorization of biotechnological and biosimilar medicines in relation to the management of the nomenclature.

FDA funds regulatory science pilot for biosimilars

Home/Policies & Legislation | Posted 25/03/2022

The US Food and Drug Administration (FDA) has announced US$5 million funding for research proposals under the Biosimilar User Fee Act (BsUFA III) Regulatory Science Pilot Program.

Nomenclature of biologicals and biosimilars in Argentina

Home/Policies & Legislation | Posted 11/03/2022

Author Maritza Iglesias Galiano of the Universidad Peruana Cayetano Heredia in Lima, Peru conducted a study in 2021 on the management and implementation of the nomenclature of biological and biosimilar medicines in Argentina, information of which are being summarized below.

Ireland’s new generics and biosimilars framework agreement

Home/Policies & Legislation | Posted 04/03/2022

In December 2021, Medicines for Ireland (MFI) signed a new framework agreement on the supply and pricing of non-originator, generic, biosimilar and hybrid medicines to be implemented between 2021‒2025.

Nomenclature of biologicals and biosimilars in Brazil

Home/Policies & Legislation | Posted 25/02/2022

This article addresses with the management and implementation of the nomenclature of biological and biosimilar medicines in Brazil, the study of which was carried out in 2021 by Maritza Iglesias Galiano of the Universidad Peruana Cayetano Heredia in Lima, Peru.

Australia introduces new bill to address drug shortages

Home/Policies & Legislation | Posted 28/01/2022

Australia’s parliament has approved a new bill aimed at mitigating drug shortages in the country and ensuring that innovative medicines are accessible, available and affordable for all Australians.

Generic ‘skinny’ labelling under threat in the US

Home/Policies & Legislation | Posted 05/11/2021

On 2 October 2021, GlaxoSmithKlein (GSK) was finally successful in challenging generics manufacturer Teva Pharmaceuticals (Teva) over its ‘skinny’ labelling of their beta blocker carvedilol, a generic version of Coreg.

Lawsuits and US$450 million payout for price fixing and delayed generics entry

Home/Policies & Legislation | Posted 29/10/2021

In late September 2021, Gilead Sciences, Teva and Bristol Myers Squibb, were sued by US pharmacy chains related to delayed launch of HIV generics. In early October 2021, three generics drugs companies, Taro Pharmaceuticals USA, Novartis’ Sandoz and Apotex agreed to pay almost US$450 million to resolve alleged claims that they illegally collaborated on price, supply and allocation of numerous medications.

FDA publishes final Q&A on biosimilar development and the BPCI Act

Home/Policies & Legislation | Posted 15/10/2021

The US Food and Drug Administration (FDA) has published its final guidance document on questions and answers related to biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BCPI Act).

FDA voices concerns around drug patents and competition

Home/Policies & Legislation | Posted 08/10/2021

On 10 September 2021, acting US Food and Drug Administration (FDA) commissioner Janet Woodcock, sent a letter to the US Patent and Trademark Office (PTO), outlining the agency’s concerns around drug patents and competition.

USA BIOSIM Act introduction

Home/Policies & Legislation | Posted 17/09/2021

The Bolstering Innovative Option to Save Immediately on Medicines Act (BIOSIM Act) was introduced in the US on 22 April 2021. This hopes to encourage greater uptake and use of biosimilar therapies by increasing biosimilar reimbursement for healthcare providers in Medicare Part B [1].

South Korea includes data exclusivity period for paediatric drugs approved abroad

Home/Policies & Legislation | Posted 10/09/2021

As of 5 May 2021, South Korea has updated the re-examination periods for post-marketing surveillance (PMS) of approved drugs. This now includes a four-year re-examination period for PMS that can now be granted for paediatric drugs approved based on both ‘domestic’ and ‘foreign’ clinical trials.

MERCOSUR: new tariff for biological and biosimilar without Latin equity

Home/Policies & Legislation | Posted 03/09/2021

Within the pharmaceutical industry, the biosimilars business is growing and consolidating both internationally and locally. It is within this framework that MERCOSUR announced the new tariff to be implemented.

New trade agreement between Mexico, the US and Canada

Home/Policies & Legislation | Posted 27/08/2021

The new trade agreement between Mexico, the US and Canada, now called the T-MEC entered into force on 1 July 2020.

Use of generic drugs is promoted in Peru

Home/Policies & Legislation | Posted 23/07/2021

To promote the use of generic medicines in Peru, on 31 October 2019, the Executive Branch published regulations through Supreme Decree No. 026-2019-SA, which established mechanisms to ensure access to lower-cost medicines. The decree recognizes the need to adopt measures that favour the population’s access to essential medicines, biological products, and medical devices.

A new dawn for China’s patent law

Home/Policies & Legislation | Posted 16/07/2021

China has made changes to its patent law which were enacted on 1 June 2021. The revisions mean China’s new patent law system resembles the US Hatch-Waxman approach and include a patent linkage system and patent term extensions.

Affordable Care Act to stand in USA

Home/Policies & Legislation | Posted 09/07/2021

On 17 June 2021, the US Supreme Court ruled to uphold the Affordable Care Act (ACA) and Obamacare. This ensures the current pathway for biosimilars to reach the US market will be maintained which will provide access to cheaper versions of expensive biological therapies.

Proposals for the commercialisation of generics move forward in Chile

Home/Policies & Legislation | Posted 02/07/2021

The project known as the Medicines Law 2, led by a Joint Commission, seeks to settle discrepancies between senators and deputies regarding the sale of bioequivalent and generic medicines in Chile. The project, which is in its third stage, amends the Health Code to regulate generic drugs in order to prevent the vertical integration of pharmaceutical companies and pharmacies. In this way, it seeks to solve some pending issues left by the current drug 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.