Biosimilars/General

Biosimilars approved in Europe

Last update: 20 June 2025

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

Biosimilars approved in the US

Last update: 22 May 2025

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Biosimilars approved in Australia

Last update: 6 May 2025

In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.

Chinese biosimilars go global: growth, partnerships, and challenges

Chinese biosimilars have gained global traction, with companies like Henlius and Bio-Thera securing international approvals. Despite challenges, China’s innovation and partnerships position it as a key biopharmaceutical player.

Biosimilars approved in Canada

Last update: 28 March 2025

In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada.

Stelara biosimilars enter US market with 85% discount in 2025

In February 2025, Teva Pharmaceuticals and Alvotech announced the availability of Selardsi (ustekinumab-aekn) in the US, followed by Sandoz’s Pyzchiva (ustekinumab-ttwe). These two products are biosimilars to the originator drug, Johnson & Johnson’s Stelara (ustekinumab). 

IFPMA publishes position on pharmacy-mediated substitution for biosimilars

In January 2025, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published a position paper, ‘Pharmacy-mediated substitution for biosimilars’.

The ustekinumab shift: biosimilars displace Stelara’s market leadership

The ustekinumab market is heating up as biosimilar developers aggressively challenge the dominance of Stelara, Johnson & Johnson’s blockbuster drug for autoimmune diseases. With eight biosimilars approved in Europe and seven in the US, the competition is fierce, and the stakes are high. 

Brazilian law establishes December 16 as National Biosimilar Day

On 6 January 2025, President Luiz Inácio Lula da Silva sanctioned Law 15.087/25, officially declaring December 16 as National Biosimilar Drug Day in Brazil. The law, published in the Official Gazette of the Union, aims to raise awareness about the importance of biosimilars in the healthcare system.

Biologicals and biosimilars available for IBD in Canada

The GI Society (Canadian Society of Intestinal Research) recently published an updated list of originator biologicals and biosimilars used to treat inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), in Canada.

Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia

In recent years, biosimilar medicines have gained increased support and access in Australia through the Pharmaceutical Benefits Scheme (PBS), a government programme designed to subsidize essential medicines and make them affordable for all Australians. Biosimilars are versions of original biological medicines that are highly similar in terms of quality, safety, and efficacy but are generally more affordable.

SBR issues consensus on interchangeability of reference products and biosimilars

On 25 September 2024, the Brazilian Society of Rheumatology (Sociedade Brasileira de Reumatologia, SBR) shared its position and consensus on the interchangeability between reference products and biosimilars, a topic of great importance for clinical practice, especially in light of recent regulatory developments by Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária, ANVISA) and other international authorities. 

Innovative direct purchase agreement sees adalimumab biosimilar prices slashed

On 1 October 2024, Blue Shield of California in the US announced that it will pay far less for an adalimumab biosimilar. The transparent net price paid by the health plan provider will be US$525 per monthly dose, compared to the market-reported net price of reference product Humira at US$2,100.

Stelara biosimilar available at US$0 for Accredo patients

On 5 September 2024, Evernorth Health Services in the US announced that a biosimilar of Johnson and Johnson’s Stelara (ustekinumab) will be available for US$0 out of pocket for eligible patients of its specialty pharmacy, Accredo.

Ten best-selling biosimilars in Brazil in 2023

Biosimilars experienced a notable increase in sales during 2023, according to a study published by the Brazilian Association of Generic and Biosimilar Drug Industries (PróGenéricos). The data reveal that about 892,000 units of biosimilars were sold, representing a 43% growth compared to 2022.

International biosimilars players expanding their presence in China

The market for copy biologicals in China has significantly grown over the past decade. By early 2022, over 60 pharmaceutical companies were involved in the development of copy biological products [1].

Boehringer and GoodRx make Humira biosimilar available at 92% discount

On 18 July 2024, it was announced that Boehringer Ingelheim (Boehringer) and GoodRx, the leading prescription savings platform in the US, launched a patient affordability initiative. From now on, Boehringer's citrate-free adalimumab-adbm, a biosimilar to Humira (adalimumab), will be available at a 92% discount to the list price of the AbbVie originator drug, exclusively on GoodRx.

Humira's resilience in the face of biosimilar competition

AbbVie’s Humira (adalimumab) has retained more than 80% of patients in the last year (Q3/2023 to Q2/2024), despite the availability of nine lower-priced rival products available in the US. This raises questions among drug pricing experts and analysts about whether the market for prescription biosimilars can survive in its current form.

Boehringer Ingelheim to expand access to adalimumab biosimilar

On 13 May 2024, Boehringer Ingelheim (Boehringer) announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to AbbVie’s Humira (adalimumab) in the US.

Challenges and progress in the registration of biosimilars in Latin America

Biosimilar medicines offer an effective and economical alternative to biotechnological medicines, with a rapidly expanding global market. However, Latin America still faces several significant challenges. The obstacles and advancements experienced in recent years are detailed below.

Canada's path to biosimilar adoption and healthcare accessibility: insights from British Columbia

Canada’s British Columbia transitioned to biosimilars in November 2019, achieving significant cost savings reinvested in BC PharmaCare. This initiative has improved drug coverage, expanding access to various medications and medical devices.

Disruption in the US adalimumab market

In April 2024, Evernorth Health Services in the US announced that a biosimilar of AbbVie’s Humira ( adalimumab) will be available for US$0 out of pocket for eligible patients of its specialty pharmacy, Accredo. This announcement follows the news that prescriptions for adalimumab biosimilars have spiked to 36% after leading pharmacy benefit manager CVS Caremark removed the branded reference product from its major national commercial formularies in January 2024.

Addressing the persistent gap in Medicare access to Humira biosimilars

In an article by Dr Joshua Cohen, he discusses the challenges facing the adoption of biosimilars in the US, particularly focusing on Medicare beneficiaries' access to these lower-cost alternatives to brand-name biologicals like Humira. 

Brazil advances in follow-on biologicals/biosimilars approvals, trailing Europe

Brazil is the fourth-largest market in terms of approved follow-on biological medications worldwide. As of May 2023, Brazil has approved 52 follow-on biological medicines [1] and approximately 30 biological products awaiting testing or already being tested by the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária) [2].

Insurer perspective on increasing biosimilar uptake in Canada

In November 2023, Canada’s Prince Edward Island (PEI) became the 11th Canadian jurisdiction to announce the adoption of biosimilars switching policies [1-10]. This follows the trend in Canada, to try to increase the uptake of biosimilars.

CVS Caremark removes Humira in the US and Sandoz launches Hyrimoz in Europe

It has been announced that the US’ CSV Caremark, a CVS Health company and one of the country’s largest pharmacy benefit managers (PBMs), will remove AbbVie’s Humira (adalimumab), from its major national commercial formularies effective 1 April 2024, in favour of biosimilar options. In Europe, Sandoz has launched its biosimilar Hyrimoz (adalimumab), a citrate-free high-concentration formulation (HCF) indicated for all conditions of the reference medicine. 

Canada’s Prince Edward Island adopts biosimilars switching policy

Canada’s Prince Edward Island (PEI) becomes the 11th Canadian jurisdiction to announce the adoption of biosimilars switching policies. 

Biosimilars of omalizumab

Last update: 3 November 2017

Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes [1]. Unlike an ordinary anti-IgE antibody, it does not bind to IgE that is already bound by the high affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and antigen-presenting dendritic cells.

Biosimilars of adalimumab

Last update: 11 March 2024

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

ASCO policy statement on biosimilars and interchangeables in oncology updated

The American Society of Clinical Oncology (ASCO) has released a new policy statement on the use of biosimilar and interchangeable products in oncology.

The statement proposes guidance and recommendations for stakeholders, including manufacturers, payers, regulatory agencies, clinicians, and patients, to ensure equitable access to high-quality care and to address challenges to biosimilar uptake [1].

Biosimilars approved in Japan

Last update: 24 October 2023

In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry for Health Labour and Welfare (MHLW).

Promotion of biosimilar product development in Puerto Rico

The Puerto Rico Economic Development Bank (Banco de Desarrollo Económico para Puerto Rico, BDE)announced in August 2023 a funding of US$3.85 million for Biosimilar Sciences PR, LLC (Biosimilar Sciences) and Ocyon Bio PR Inc (OcyonBio) to facilitate the purchase of specialized biotechnology equipment. This funding comes from the State Small Business Credit Initiative (SSBCI) of the US Treasury for Small Businesses.

CVS’ Cordavis to launch Sandoz’s Hyrimoz (adalimumab)

In August 2023, CVS Health Corp announced it has launched a new company called Cordavis that will work directly with manufacturers to commercialize and co-produce biosimilar medicines for the US market.

Coherus retracts AbbVie restraining order in Humira biosimilar dispute

Coherus BioSciences agreed to retract its restraining order against AbbVie in June 2023, an action taken to prevent AbbVie from terminating its Humira licence deal [1].

Proposal to widen access to trastuzumab in New Zealand

In New Zealand there has been a proposal to widen access to intravenous trastuzumab from Herceptin to a biosimilar trastuzumab called Herzuma from 1 December 2023. 

GADECCU position statement on biosimilars updated

GADECCU (Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa), the Argentine Group for Crohn's Disease and Ulcerative Colitis, after providing key definitions on medical switch, non-medical switch and automatic substitution [1] and considering all the scientific information available, has updated its position in March 2023 regarding the use of biological medicines in clinical practice.

GADECCU presents a new positioning on biosimilars

The Argentine Group for Crohn's Disease and Ulcerative Colitis (Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa, GADECCU) has released an updated position statement on biosimilars, particularly regarding the alternate use of innovative biological drugs and biosimilars during the same chronic treatment in patients with inflammatory bowel disease.

Joint statement on biosimilars in immune-mediated diseases in Spain

A study conducted and published by Monte-Boquet E et al. aimed to improve knowledge and use of biosimilar medicines in immune-mediated diseases, and to produce a unified framework for the use of biosimilars [1].

An update on the joint EMA-HMA statement on interchangeability of biosimilar

On 21 April 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued an updated joint statement on the interchangeability of biosimilars approved in the EU.

Biosimilars switching policies for Canada’s Newfoundland and Labrador, and Yukon

The Canadian provinces of Newfoundland and Labrador, and Yukon, become the 9th and 10th Canadian provinces to announce that they are adopting biosimilars switching policies.

Advancing biosimilar drug development with pharmacodynamic biomarkers

US Food and Drug Administration (FDA) researchers are studying the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. These studies could make the process of developing biosimilars more efficient and faster.

Spanish Psoriasis Group update biosimilar position statement

The use of biosimilar drugs in the treatment of moderate to severe psoriasis has changed the current therapeutic approach. Evidence from clinical trials and real-world experiences has led to an update in the positioning of the Spanish Psoriasis Group (GPS) [1].

Challenges for Spanish generics and biosimilars industry: sustainable profitability

Spain's generics and biosimilars industry is calling for their profitability to be guaranteed after authorities lowered the reference prices of over 1,000 drugs.

Lilly, Novo Nordisk and Sanofi slash prices of insulin in the US

In March 2023, major insulin manufacturers Eli Lilly (Lilly), Novo Nordisk and Sanofi announced price reductions of 70%, 75% and 78% respectively, for their most commonly prescribed insulins in the US, starting from first quarter of 2023 for Lilly and from 1 January 2024 for Novo Nordisk and Sanofi. The three companies control over 90% of the global insulin market. 

American College of Rheumatology position statement on biosimilars updated

In late 2022, the American College of Rheumatology (ACR) issued a position statement on biosimilars [1] in which they emphasized their strong belief that safe and effective treatments should be available to patients at the lowest possible cost. This is an update of previous position statements [2].

A Canadian gastro-enterologist’s view on advising on biosimilars

Acting as a ‘trusted advisor’ when answering questions about biological and biosimilar products is important for Canadian physician, Dr Dustin Loomes reported in a recent article.

Biosimilars of pembrolizumab

Pembrolizumab is a humanized (from mouse) monoclonal antibody that binds to, and blocks PD-1 located on lymphocytes. It is an anticancer medication used in the treatment of melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial cancer (cancer of the bladder and urinary tract) and renal cell carcinoma (kidney cancer).

US PBMs add multiple Humira biosimilars to formularies

In the US it has been announced that several pharmacy benefit managers (PBMs) will be adding multiple biosimilar versions of AbbVie’s Humira (adalimumab) to their formularies in 2023.

Canada’s Ontario introduces biosimilars switching policy

The Canadian province of Ontario is the latest to introduce a biosimilars switching policy. Under the terms of the policy, Ontario Drug Benefit (ODB) recipients who are on an originator biological will be required to transition to a Health Canada approved biosimilar version of the drug.

Key facts of biosimilars approval regulation in Brazil

This article provides a brief overview of the important aspects and an update on the regulatory pathways for approval of biological products in Brazil [1].

Canada’s Saskatchewan province introduces biosimilars switching policy

The Canadian province of Saskatchewan is the latest to introduce a biosimilars switching policy. As of October 2022, the province joins British Columbia (BC) [1], Quebec [2], Alberta, Ontario [3], New Brunswick [4], Nova Scotia [5], and the Northwest Territories [6] in introducing biosimilars switching policies.

Biosimilars of etanercept

Last update: 20 November 2020 

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

EMA calls for biosimilar interchangeability across the EU

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued on 19 September 2022 a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar. This will allow more patients to have access to biological medicines necessary for treating diseases such as cancer, diabetes and rheumatic diseases.

Glosario de términos principales

Last update: 23 September 2022

Desde el lanzamiento del primer biosimilar en Europa en abril de 2006, se ha debatido de manera reiterada sobre el uso adecuado de la terminología relativa a los medicamentos biológicos, principalmente en inglés.

American Academy of Ophthalmology biosimilars guidance details

The American Academy of Ophthalmology (AAO) recognizes the potential societal value of biosimilars for improving care of patients with eye disease.  Biosimilars should have sufficient research demonstrating their safety and effectiveness for treatment of eye disease. In January 2022, the AAO issued a policy statement on the biosimilars in ophthalmologic use [1].

Current status of monoclonal antibody biosimilars approved in Latin America

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

British Columbia expands biosimilar switching programme to include insulin

The Canadian province of British Columbia has expanded its biosimilar switching programme to include rapid-acting insulin products. Patients taking Humalog (insulin lispro) and NovoRapid (insulin aspart) will have six months to switch to a biosimilar version.

Viatris/Biocon launch two versions of Semglee to accommodate rebates

Viatris (formerly Mylan) and Biocon have launched two versions of their interchangeable biosimilar Semglee (insulin glargine) on the US market, at different price points, in order to accommodate rebates and increase market share.

Interchangeable insulin glargine biosimilars available through Prime Therapeutics and Walgreens

In November 2021, it was announced that, in the US, insulin glargine biosimilars co-developed by Viatris and Biocon Biologics will be preferentially offered through Prime Therapeutics pharmacy benefit management organization and will be available to members of Walgreens Prescription Savings Club.

Patients from Uruguay request that non-interchangeability of biotherapeutics be regulated

Patients demand guarantees that authorities will not make switches of biotherapeutic drugs solely for economic reasons and without considering the medical decision. This was expressed by the Uruguay Patients Alliance at the First National Biotechnology Forum. The main objective of this forum was to create a meeting place for the academic world, patients and health authorities in the field of biotechnology and innovation.

Concerns over Canada’s New Brunswick transition to biosimilars

Several biological medications whose patents have expired will no longer be covered under provincial drug plans of New Brunswick, Canada as of 30 November 2021. These are to be replaced by cheaper biosimilar versions; however, inflammatory disease associations have expressed concerns about the rapid transition.

AMD position statement on the use of biocomparables for psoriasis

The Mexican Academy of Dermatology (AMD) is a non-profit civil association founded in 1952 and formed by a group of relevant dermatologists dedicated to sharing experiences and keeping up to date with the latest advances in research. This group has developed the following position statement on biosimilars for psoriasis.