Reports

PD biomarkers for biosimilar development and approval

Home/Reports | Posted 26/11/2021

At the DIA Biosimilars Conference 2021, Dr Peter Stein, Director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA), gave a presentation entitled ‘An update on the FDA biosimilar program: progress and directions, 2021’ [1].

Biosimilar launches and uptake expected to increase in the US

Home/Reports | Posted 22/10/2021

In a presentation given by Doug Long, the expected launches and increase in uptake of biosimilars for the US market were discussed.

Biosimilars approved, launched or in development in the US

Home/Reports | Posted 15/10/2021

In a presentation based on the report by health information technology and clinical research company IQVIA ‘Biosimilars in the US 2020–2024: Competition, savings and sustainability’ biosimilars launched, approved or in development for the US market were discussed [1].

GMP certification requirements in Chile, Cuba and Venezuela

Home/Reports | Posted 08/10/2021

The increasingly globalized nature of commerce allows manufacturers to outsource activities, such as procurement of raw materials overseas, where different regulatory requirements may exist. Thus, there is a need to ensure that the good manufacturing practices (GMP) guidelines adopted by the regulatory authorities (RAs) and international organizations (IOs) are harmonized and robust. A robust set of GMP guidelines helps in safeguarding public health by assuring the quality, safety and efficacy of the biopharmaceuticals [1].

US savings from biosimilars could exceed US$100 billion

Home/Reports | Posted 08/10/2021

At the AAM 2021 Annual Meeting, Mr Doug Long* of IQVIA delivered a presentation on US biosimilar market access, indicating savings over the next five years in the US as a result of biosimilars are projected to exceed US$100 billion.

US opinion on prescription drug price and regulation

Home/Reports | Posted 01/10/2021

Kaiser Family Foundation (KFF) research released the results of the KFF Health Tracking Poll (18–25 May 2021) in June 2021. The poll has revealed that many in the US believe drug prices are unreasonable [1].

GMP certification requirements in Central American countries

Home/Reports | Posted 01/10/2021

Before submitting documentation for the marketing authorization of a medicinal product in several countries in Latin America, there are several requirements that have to be taken into consideration

GMP certification requirements in Andean Community countries

Home/Reports | Posted 24/09/2021

Market authorisation of a medicinal product represents a major effort for the pharmaceutical industry with a detailed plan with all the steps that are involved in the process.

GMP certification requirements in Argentina, Brazil and Mexico

Home/Reports | Posted 17/09/2021

Marketing authorisation (MA) of a medicinal product is the process of reviewing and assessing the evidence to support that product, in relation to its marketing, finalized by granting of a licence to be sold.

US opinion on prescription drug affordability

Home/Reports | Posted 24/09/2021

In June 2021, non-profit organization, Kaiser Family Foundation (KFF) research, released the results of KFF Health Tracking Poll (18–25 May 2021) regarding public opinion on prescription drugs and their prices in the US.

GABiC proposes the use of biosimilars as strategy for innovation and sustainability

Home/Reports | Posted 10/09/2021

The commitment to biosimilars as a strategy to promote innovation and sustainability is what motivated the creation of the Argentine Quality Biosimilars Group (Grupo Argentino de Biosimilares de Calidad, GABiC) in 2019, made up of the companies Amgen, Gobbi Novag and Sandoz.

Biosimilars as a sustainable option for the health system in Argentina

Home/Reports | Posted 03/09/2021

The COVID-19 pandemic in Argentina has raised questions about its impact on highly complex medical treatments, which, because they are imported, are costly to the social security system, to the point that they make coverage unviable for many.

Comparison of authorization requirements for biological and biosimilar medicines

Home/Reports | Posted 27/08/2021

The development of biosimilar medicines presupposes a paradigm shift from the traditional model used with an innovative medicine. Meanwhile, for a new molecular entity, the evidence for its development is based on generating data confirming its safety and efficacy.

Use of biosimilars generates savings in the Spanish health budget of 2021

Home/Reports | Posted 30/07/2021

It is estimated that the national health system (Sistema Nacional de Salud, SNS) will be able to save €930 million due to the use of biosimilars in 2021, according to the results of the Budgetary Impact Analysis of Biosimilar Medicines in the SNS of Spain (2009–2022) [1].

Five main barriers to developing biosimilars

Home/Reports | Posted 23/07/2021

According to Dr Ash Ramzan, principal consultant at Woodley BioReg, there are five main barriers preventing biosimilars from reaching their full potential.

Position of CAEME on biological and biosimilar drugs in Argentina

Home/Reports | Posted 02/07/2021

The pharmaceutical companies that comprise the Argentine Chamber of Medicinal Products (Cámara Argentina de Especialidades Medicinales, CAEME) consider that biosimilar medicines are necessary for the sustainability of the healthcare system and patient access to effective treatment.

A few drugs account for most of Medicare Part B spending

Home/Reports | Posted 25/06/2021

Findings from an analysis carried out by KFF of Medicare* spending in 2019 found that most of the Medicare Part B** spending on drugs was on a relatively small number of drugs [1]. KFF is a non-profit organization that provides independent information on national health issues.

A broader and stronger generic drug market is promoted in Mexico

Home/Reports | Posted 21/06/2021

During a press conference held on 14 November 2020, ‘A new generic medicines market’ strategy was revealed, with which ’the Health and Economic Secretaries will strengthen the companies producing generic medicines, through the linking mechanisms and technological tools, based on the principles of innovation, transparency, competitiveness and legality’ fostering firmly a wider and solid generic medicines market, for the benefit of Mexican nationals.

A few drugs account for most of Medicare Part D spending

Home/Reports | Posted 11/06/2021

An analysis of Medicare* spending in 2019 was recently carried out by KFF, a non-profit organization that provides independent information on national health issues. The analysis found that most of the Medicare Part D** spending on drugs was on a relatively small number of drugs with only one manufacturer and without generic or biosimilar competitors [1].

A small number of drugs account for most of Medicare spending

Home/Reports | Posted 04/06/2021

A new analysis carried out by KFF, a non-profit organization that provides independent information on national health issues, has found that a relatively small share of drugs without generic or biosimilar competitors, accounted for a disproportionate share of prescription drug spending in the US Medicare* system in 2019 [1].

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