Biosimilars/General

Current status of monoclonal antibody biosimilars approved in Latin America

Biosimilars/General | Posted 24/06/2022

By the end of 2021, biosimilar antibodies of rituximab, trastuzumab, infliximab, adalimumab and bevacizumab were expected to be commercialized in Latin America with 25 different brand names.

Overview of monoclonal antibody biosimilars in Latin America

Biosimilars/General | Posted 17/06/2022

This article describes the current situation of biosimilar monoclonal antibodies in 10 countries of Latin America and their potential to reduce the cost of antibody therapies.

American Academy of Ophthalmology biosimilars position statement published

Biosimilars/General | Posted 10/06/2022

The American Academy of Ophthalmology issued a policy statement on the use of biosimilars in ophthalmic practice in January 2022 [1].

US prescription drug expenditure projection report

Biosimilars/General | Posted 03/06/2022

United States expenditure on pharmaceuticals was up in 2021, finds a report published in American Journal of Health-System Pharmacy [1]. It also highlights that increased uptake of biosimilars is allowing for healthcare savings yet overall spending on drugs in the US will increase by up to 6% in 2022.

HHS new study on biosimilar use and expanded trials will include older patients

Biosimilars/General | Posted 29/04/2022

In March 2022, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced that it will launch a study on biosimilars use and spending trends in Medicare Part B. The US Food and Drug Administration (FDA) has also made changes to clinical trials to improve information available on use of biosimilars in older patients.

Needle-free delivery of biological drugs from Rani and Progenity

Biosimilars/General | Posted 22/04/2022

Rani Therapeutics and Progenity have announced the respective launch and development of new oral, needle-free methods to deliver large biological drug molecules.

British Columbia adds coverage for three new enoxaparin biosimilars

Biosimilars/General | Posted 15/04/2022

British Columbia, Canada has added PharmaCare coverage for three new enoxaparin biosimilars, a blood thinner used to prevent and treat blood clots.

Biocomparables approved in Mexico

Biosimilars/General | Posted 08/04/2022

In Mexico, biological products with expired patents are known as biocomparable biotechnology drugs (medicamentos biotecnológicos biocomparables). The regulatory body in charge of approving biocomparables is the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS).

Consortium of US hospitals to manufacture and sell biosimilar insulin

Biosimilars/General | Posted 01/04/2022

A consortium of large US hospitals, through the non-profit company Civica Rx, are to manufacture and sell biosimilar insulin capped at US$30 per vial.

Biosimilars approved in Argentina

Biosimilars/General | Posted 11/03/2022

In Argentina, the regulatory agency in charge of approving biological drugs is the National Administration of Drugs, Food and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT).

Key considerations when switching to biosimilar insulin

Biosimilars/General | Posted 04/03/2022

Biosimilar insulins can offer a cheaper alternative to originator insulators and substantial savings for healthcare systems. A recent ‘Quick guide: Initiating or switching to a biosimilar insulin’, [1] published in the Journal of Diabetes Nursing, outlines key aspects to consider when switching.

Nova Scotia, Canada implements biosimilar switching policy

Biosimilars/General | Posted 25/02/2022

Nova Scotia becomes the fifth Canadian province to implement a biosimilar switching policy, meaning that half of Canada’s provinces have now implemented such policies.

Amgen predicts a steady flow of biosimilar launches

Biosimilars/General | Posted 18/02/2022

Amgen CEO Robert Bradway predicted expanding the company’s biosimilars business with a steady flow of biosimilar launches at the J.P. Morgan Healthcare Conference, which was held on 11 January 2022.

Biosimilars approved in Colombia

Biosimilars/General | Posted 11/02/2022

In Colombia, the regulatory body for the approval of biologicals is the National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA).

Glossary of key terms

Biosimilars/General | Posted 26/10/2012

Last update: 9 June 2017

Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has been recognized as a problem by EMA, who has expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the terms in the scientific literature and elsewhere [1].

Northwest Territories, Canada announces biosimilars switching policy

Biosimilars/General | Posted 04/02/2022

The Northwest Territories (NWT) has become the fifth jurisdiction in Canada to implement a biosimilars switching policy. The policy begins from 21 December 2021 and includes 10 biologicals.

Biosimilars approved in Ecuador

Biosimilars/General | Posted 28/01/2022

In Ecuador, the regulatory body for the approval of biologicals is the National Agency for Regulation, Control and Health Surveillance (ARCSA).

Biosimilars applications under review by EMA – January 2022

Biosimilars/General | Posted 21/01/2022

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Biosimilars approved in Brazil

Biosimilars/General | Posted 14/01/2022

In Brazil, the regulatory body for the approval of biologicals is the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA), which is linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.

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