Biosimilars

Canada’s Prince Edward Island adopts biosimilars switching policy

Biosimilars/General | Posted 06/11/2023

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

Biosimilars/Research | Posted 06/11/2023

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

Biosimilars/News | Posted 31/10/2023

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

Biosimilars/News | Posted 24/10/2023

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

Biosimilars/General | Posted 24/10/2023

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

Biosimilars/Research | Posted 24/10/2023

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

Biosimilars/Research | Posted 17/10/2023

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

Biosimilars/News | Posted 17/10/2023

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

Biosimilars/General | Posted 17/10/2023

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

Biosimilars/News | Posted 09/10/2023

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

Biosimilars/Research | Posted 09/10/2023

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

Biosimilars/News | Posted 03/10/2023

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)

Biosimilars/General | Posted 03/10/2023

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

Biosimilars/Research | Posted 03/10/2023

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

Biosimilars/News | Posted 14/09/2023

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

Biosimilars/Research | Posted 14/09/2023

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

Biosimilars/News | Posted 24/08/2023

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

Biosimilars/Research | Posted 17/08/2023

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

Biosimilars/News | Posted 10/08/2023

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

Biosimilars/General | Posted 10/08/2023

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].