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. 

EC approval of trastuzumab biosimilar Herwenda

The European Commission (EC) granted marketing authorization for trastuzumab biosimilar Herwenda on 15 November 2023. The biosimilar of Herwenda is developed by EirGenix, Inc.

EC approval of first ustekinumab biosimilar Uzpruvo

On 5 January 2024, the European Commission (EC) granted marketing authorization for the first ustekinumab biosimilar Uzpruvo (AVT04). The biosimilar of Uzpruvo is developed by Iceland-based biosimilar manufacturer Alvotech.

EMA recommends approval of ranibizumab biosimilar Rimmyrah

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use announced on 9 November 2023 that it had recommended granting of marketing authorization for Rimmyrah (ranibizumab), a biosimilar that references ophthalmology drug, Lucentis.

FDA approves Zymfentra and advances for Yuflyma in the US

On 23 October 2023, the US Food and Drug Administration (FDA) approved Celltrion’s Zymfentra (infliximab-dyyb) biosimilar as the first subcutaneous (SC) formulation of infliximab. In addition, Celltrion USA signed a contract with Ventegra to add Yuflyma (adalimumab-aaty) as a preferred formulary product in both public and private insurance markets.

Biological therapies for psoriasis: evaluating durability and persistent benefits

A review by Rusiñol et al. emphasized the significant impact of biologicals on psoriasis management. Anti-IL-17 and anti-IL-23 biologicals are regarded as highly effective and long-lasting treatments in real-world scenarios, with IL-23-targeting biologicals showing the best safety profile and potential to modify the natural course of psoriasis.

Switches between biosimilars and their reference products

Biologicals are the fastest-growing class of medications in the United States and account for a substantial and growing portion of healthcare costs. The Biologics Price Competition Act of 2009 created an abbreviated approval pathway for the US Food and Drug Administration (FDA) to help provide patients with greater access to safe and effective biological products. As of 1 November 2023, FDA has approved 44 biosimilar products, 7 of which are interchangeable biosimilars. These products can be used to treat many conditions such as chronic skin and bowel diseases, arthritis, kidney conditions, diabetes, multiple sclerosis, macular degeneration, and cancer.

EC approval of natalizumab, aflibercept and tocilizumab biosimilars

In September 2023, the European Commission (EC) granted marketing authorization for the biosimilars of Tyruko (natalizumab), Yesafili (aflibercept), and Tyenne (tocilizumab).

Latin America's biosimilars market: regulatory, institutional, and technological aspects

According to a study led by Bas (2023), the Latin American (LA) biosimilars market is positioned for substantial growth over the next decades as a cost-effective alternative to expensive patented biomolecules [1].

EMA recommends approval of first ustekinumab biosimilar Uzpruvo

On 9 November 2023, the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Uzpruvo (ustekinumab), a biosimilar of reference product Stelara, intended for the treatment plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults.

FDA approves first interchangeable ustekinumab biosimilar Wezlana

On 31 October 2023, the US Food and Drug Administration (FDA) approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.

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. 

Impact of trastuzumab biosimilars use in metastatic HER2-positive breast cancer

A review conducted by Sarder and Ahmad attempted to describe and analyse the studies published in peer-reviewed literature on the use of trastuzumab biosimilars for patients with HER2-positive breast cancer, including their efficacy, safety, pharmacokinetic and pharmacodynamic properties [1].

Alvotech biosimilars: FDA ustekinumab application rejection; adalimumab interchangeability designation re-submission

In October 2023, Iceland-based biosimilar manufacturer Alvotech, announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Stelara (ustekinumab). As such, the application was not approved. This follows Alvotech’s September 2023 resubmission of a BLA for their high-concentration biosimilar formulation to AbbVie’s blockbuster arthritis treatment Humira (adalimumab), AVT02 [1], following receipt of a similar CRL.

Japanese approval for first ustekinumab biosimilar

Iceland-based biosimilar manufacturer Alvotech announced on 25 September 2023 that its commercialization partner in Japan, Fuji Pharma Co Ltd (Fuji) had received marketing approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its ustekinumab biosimilar AVT04 in Japan.

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].

Biosimilar anti-VEGF: transforming retina treatment economics in South Asia

Anti-vascular endothelial growth factors (anti-VEGF) agents combat retinal diseases causing blindness. However, high costs and non-adherence pose challenges. Ophthalmic anti-VEGF ranibizumab biosimilars, which have received multiple approvals in South Asia, are helping to reduce healthcare costs and revolutionize ophthalmic treatments.

Long-term data support the clinical comparability of AVT04 to Stelara

Long-term efficacy, safety and tolerability data for the AVT04 ustekinumab biosimilar candidate developed in partnership by Alvotech and STADA corroborate the finding of therapeutic equivalence to the Stelara^® reference product in patients with moderate-to-severe chronic plaque psoriasis (PsO) in the primary endpoint at Week 12.

FDA approves first tocilizumab biosimilar Tofidence

On 29 September 2023, the US Food and Drug Administration approved Tofidence (tocilizumab-bavi) as the first biosimilar to Actemra (tocilizumab). Tofidence is first-of-its-kind biosimilar tocilizumab to receive approval in the US.

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.

FDA grants interchangeable designation to adalimumab biosimilar Abrilada

US-based pharma giant Pfizer announced on 5 October 2023 that the US Food and Drug Administration (FDA) has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). The interchangeable designation applies to all approved indications of Abrilada, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. 

Topline results for Hadlima biosimilar in interchangeability study

Samsung Bioepis and Organon announced topline results from interchangeability study of their Humira biosimilar, SB5/Hadlima, in August 2023.

EMA recommends approval of trastuzumab biosimilar Herwenda

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 September 2023 that it had recommended granting of marketing authorization for the trastuzumab biosimilar Herwenda, 150 mg, for intravenous use.

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.

IBD barriers: an analysis of Latin America

A comprehensive review conducted by Queiroz et al. in 2023 [1] explores the barriers to accessing IBD care throughout Latin America, a large and diverse region used to describe South America, Central America, Mexico and the islands of the Caribbean. Each one of these regions/countries carries a different cultural and historical background, diverse political systems and a distinct healthcare system.

FDA approves first natalizumab biosimilar Tyruko for MS

On 24 August 2023, the US Food and Drug Administration approved Tyruko (natalizumab-sztn) as the first biosimilar to Tysabri (natalizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko is first-of-its-kind biosimilar natalizumab to receive approval in the US.

Ophthalmology biosimilars in Canada: a prescriber’s perspective

The first biosimilar entered the Canadian market in 2009 and the first ophthalmic biosimilar was approved in 2022. Now, a report based on the results of a 2022 survey [1], reveals the views of prescribing ophthalmology physicians in Canada on product identification, prescribing biologicals and prescribing biosimilars and switching.

EMA recommends approval of first natalizumab biosimilar Tyruko for MS

On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Tyruko (natalizumab), a biosimilar of reference product Tysabri, intended for the treatment of multiple sclerosis (MS).

Response to Opinion on: Four steps for streamlining biosimilars development

In the Opinion article, 'Biosimilars drug development: time for a paradigm shift?' published in GaBI Journal, the authors question the need for what they consider to be the arduous regulatory requirements for approval of biosimilars [1]. In response to this article, Dr Robin Thorpe, Deputy Editor-in-Chief of the journal has published a rebuttal [2], providing insightful counterpoints to the concerns raised by the authors.

EMA recommends approval of first aflibercept and tocilizumab biosimilars

On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Yesafili (aflibercept), an ophthalmology biosimilar, and Tyenne (tocilizumab), an immunosuppressant used largely for treatment of arthritis. 

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].

Four steps for streamlining biosimilars development

The cost of developing biosimilars can be prohibitively expensive. A manuscript published in GaBI Journal entitled 'Biosimilars drug development: time for a paradigm shift?' [1], explores ways in which we can see leaner and faster biosimilar clinical trials, without compromise on safety and efficacy of the drug products.

Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma

The US Food and Drug Administration (FDA) rejected Alvotech’s biologicals licence application (BLA) for their biosimilar adalimumab AVT02 in June 2023. Alvotech has also formed new partnerships with Prolifarma and Advanz Pharma for proposed biosimilars to Eylea (aflibercept) and Xolair (omalizumab), respectively.

Biosimilars: US prescriber’s attitudes and perceptions revealed

A report based on the 2021 survey carried out by the Alliance for Safe Biologic Medicines (ASBM) reveals the views of prescribing physicians, regarding the prescribing, substitution and interchangeability of biosimilars [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. 

Coherus: lowest price adalimumab biosimilars announced

Coherus BioSciences has announced that it will launch Yusimry, its adalimumab biosimilar, at the lowest price announced to date in the US. 

Clinical trial advances for Kashiv and Celltrion

US-based Kashiv Biosciences announced that ADL018, a biosimilar candidate to Xolair (omalizumab), has completed a successful global phase I clinical study in healthy volunteers. In addition, South Korea’s Celltrion announced that it received approval from the US Food and Drug Administration for the phase III investigational new drug (IND) application of its biosimilar CT-P53 for Ocrevus (ocrelizumab), a treatment for multiple sclerosis.

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.

Study investigates success of US ‘skinny label’ approval pathway

Recent court rulings have put the US’ ‘skinny label’ approval pathway at risk. Now, a research letter published in JAMA Internal Medicine [1] has found approval and marketing of skinny label biosimilars have led to billions of dollars in savings to Medicare.

Celltrion: advances for Yuflyma and Vegzelma biosimilars

In the first half of 2023, South-Korea based Celltrion Biologics announced the approval of their Yuflyma (adalimumab-aaty) biosimilar in the US, the winning of a bid to supply Italy and Belgium with bevacizumab biosimilar Vegzelma.