Biosimilars

Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin

Biosimilars/News | Posted 14/10/2022

On 19 September 2022, Formycon announced details of a project to produce a biosimilar of Keytruda (pembrolizumab). This followed news that, on 16September 2022, Prestige Biopharma withdrew the Marketing Authorization Application (MAA) for their Herceptin Biosimilar, Tuznue, submitted to the European Medicines Agency (EMA).

Biosimilars of pembrolizumab

Biosimilars/General | Posted 14/10/2022

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).

FDA approves biosimilar pegfilgrastim Stimufend

Biosimilars/News | Posted 06/10/2022

On 6 September 2022, Fresenius Kabi announced that they had received approval from the US Food and Drug Administration (FDA) for their pegfilgrastim biosimilar, Stimufend (pegfilgrastim-fpgk).

Recommendations for improving biosimilar regulations in Latin America

Biosimilars/Research | Posted 06/10/2022

The biosimilar regulatory scenario is very diverse and varies widely in the large group of Latin American countries. Authors Teran et al. presented some recommendations for making biosimilar regulations in Latin America more homogeneous and comprehensive [1].

Successful trials for Sandoz and Lannett biosimilars

Biosimilars/Research | Posted 30/09/2022

On 19 September 2022, Sandoz announced positive results following its ROSALIA I/III clinical trial study for its proposed biosimilar denosumab. This follows the August announcement that Lannett Company successfully completed subject dosing in the clinical trial of its biosimilar insulin glargine.

EMA calls for biosimilar interchangeability across the EU

Biosimilars/General | Posted 23/09/2022

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.

Recommendations to address challenges to biosimilars in Latin America

Biosimilars/Research | Posted 23/09/2022

After reviewing the regulatory landscape for biosimilars [1] and access to biosimilars for cancer treatments in Latin America [2], authors Teran et al. advised several recommendations to address challenges related to poor access to biosimilars in Latin America healthcare systems.

EC approves bevacizumab biosimilar Vegzelma

Biosimilars/News | Posted 23/09/2022

On 18 August 2022, South Korea-based biologicals specialist Celltrion announced that its bevacizumab biosimilar, Vegzelma (CT-P16), had received European Commission (EC) approval.

EC approves ranibizumab biosimilar Ranivisio

Biosimilars/News | Posted 16/09/2022

On 29 August 2022, the ranibizumab biosimilar Ranivisio (FYB201), developed by Bioeq – a joint venture between Formycon and Polpharma Biologics, was granted marketing approval by the European Commission (EC).

FDA accepts application for high concentration adalimumab biosimilar

Biosimilars/News | Posted 16/09/2022

Sandoz, the generics division of Novartis, announced on 21 July 2022 that the US Food and Drug Administration (FDA) had accepted the supplemental biologics license application for the high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017) (adalimumab-adaz).

Applications for natalizumab biosimilars accepted by FDA and EMA

Biosimilars/News | Posted 09/09/2022

Applications for natalizumab biosimilars made by Sandoz (the generics division of Novartis) and Polpharma Biologics (Polpharma) have been accepted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Regulatory landscape for biosimilars in Latin America

Biosimilars/Research | Posted 09/09/2022

The biosimilar regulatory situation in Latin America varies broadly among the different countries, even though Latin America is moving towards consolidating defined and standardised regulatory pathways for these products. This article gives a summary of the biosimilar regulatory status for the countries represented by members of the panel of experts of the American Health Foundation (AHF). The countries reviewed are Chile, Colombia, Ecuador, Guatemala and Peru [1].

Totality of evidence for biosimilar pegfilgrastim Ziextenzo

Biosimilars/Research | Posted 09/09/2022

Agarwala et al. have recently published a review on the totality of evidence (ToE) for the biosimilar pegfilgrastim Ziextenzo® (LA-EP2006) matching the European Union- (EU) and US-reference biological pegfilgrastim Neulasta® (marketed by Amgen) [1].

FDA accepts application for tocilizumab biosimilar

Biosimilars/News | Posted 02/09/2022

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 1 August 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed tocilizumab biosimilar (MSB11456).

What does the designation of interchangeability for biosimilars in the US mean?

Biosimilars/Research | Posted 02/09/2022

Biologicals have significantly improved patients’ quality of life, yet, access to these critical medicines are constrained due to cost and this is being exacerbated by the misperceptions around biosimilars. In particular, imprecise terminology has been applied to biosimilars, leading to the implication that biologicals designated as interchangeable by the US Food and Drug Administration (FDA) are better biosimilars. The US is the only jurisdiction in the world with this additional designation from the regulator as an option for biosimilar sponsors to consider [1].

FDA approves first interchangeable ranibizumab biosimilar

Biosimilars/News | Posted 26/08/2022

Polpharma Biologics, Formycon and Bioeq jointly announced on 2 August 2022 that they had received approval from the US Food and Drug Administration (FDA) for their ranibizumab biosimilar (CHS-201/FYB201).

Access to biosimilars for cancer treatments in Latin America

Biosimilars/Research | Posted 26/08/2022

In many Latin America countries, patient access to biosimilars for cancer treatment remains restricted. In particular for patients with breast cancer and colorectal cancer, biosimilars can be a step further to increasing access to care [1].

Innovent-Etana bevacizumab biosimilar approved in Indonesia

Biosimilars/News | Posted 29/07/2022

Innovent announced the approval of its bevacizumab biosimilar in Indonesia, that was developed in partnership with PT Etana Biotechnologies Indonesia.

Ranibizumab biosimilar, FYB201, receives EMA recommendation

Biosimilars/News | Posted 22/07/2022

Formycon’s ranibizumab biosimilar, FYB201, has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).

Biosimilar regulations perspective in Latin America to improve cancer treatment access

Biosimilars/Research | Posted 22/07/2022

To address the issue of regulatory process of biosimilars, including intended copies*, the Americas Health Foundation (AHF) conducted a literature review and convened a panel with eight experts in biological cancer therapies and health economics to address the most salient issues concerning the regulation of biosimilars in Latin America [1].

Pegfilgrastim biosimilar Udenyca demonstrated similar immunogenicity to Neulasta

Biosimilars/Research | Posted 22/07/2022

The pegfilgrastim biosimilar Udenyca (pegfilgrastim-cbqv) is a pegylated, long-acting form of filgrastim (granulocyte colony-stimulating factor [G-CSF]). It is approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a biosimilar of the originator pegfilgrastim (Neulasta) for febrile neutropenia in patients receiving myelosuppressive chemotherapy [1, 2].

Therapeutic drug monitoring with infliximab improves disease control

Biosimilars/Research | Posted 15/07/2022

The latest study from the Norwegian Drug Monitoring (NORDRUM) trial [1] shows that proactive therapeutic drug monitoring (TDM) for patients receiving maintenance infliximab therapy improves disease control, compared to treatment without TDM.

New data on infliximab and adalimumab biosimilars at EULAR 2022

Biosimilars/News | Posted 15/07/2022

The Annual European Congress of Rheumatology (EULAR 2022) was held at the beginning of June 2022. This platform was used to announce the results of a study that showed that, in patients with rheumatoid arthritis, statistically greater improvements in clinical outcomes with subcutaneous infliximab, compared to intravenous infliximab. In addition, Samsung Bioepis announced new data on their established adalimumab biosimilar Imraldi (Hadlima outside Europe).

WHO revised guidelines for biosimilars: scientific background

Biosimilars/Research | Posted 08/07/2022

A study carried out by Kurki P et al. in 2022 reviewed the current clinical experience and scientific evidence to provide an expert perspective for updating the World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) to increase flexibility and clarity.

EMA accepts application for high concentration adalimumab biosimilar

Biosimilars/News | Posted 08/07/2022

Sandoz, the generics division of Novartis, announced on 17 June 2022 that the European Medicines Agency (EMA) has accepted the application for its high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017).

Positive phase III results for Samsung Bioepis’ Soliris biosimilar

Biosimilars/Research | Posted 08/07/2022

Samsung Bioepis announced that its biosimilar to Soliris (eculizumab) has comparable efficacy and safety and is bioequivalent to the originator.

EMA recommends approval of bevacizumab biosimilar Vegzelma

Biosimilars/News | Posted 01/07/2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 June 2022 that it had recommended granting marketing authorization for the bevacizumab biosimilar Vegzelma.

Adalimumab biosimilar MSB11022: PK and tolerability of autoinjector versus pre-filled syringe

Biosimilars/Research | Posted 01/07/2022

The antitumour necrosis factor-alpha (anti-TNF‑a) monoclonal antibody adalimumab is used to treat a variety of chronic immune-mediated inflammatory diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, juvenile arthritis and inflammatory bowel disease. The biosimilar MSB11022 (Idacio/Kromeya) has demonstrated physicochemical and functional similarity to reference adalimumab (Humira) in the preclinical setting. Further study in the clinical setting has established equivalent pharmacokinetics (PK) and efficacy, and comparable safety and immunogenicity for MSB11022 versus adalimumab. MSB11022 is available in three delivery formats: pre-filled syringe, vial and autoinjector. Offering a choice of devices can address patient needs and potentially improve adherence to therapy. Self-injection via pre-filled syringes may be challenging for some patients, due to issues such as needle phobia, pain-related concerns and arthritis hand pain making self-injection more difficult. The availability of alternative self-injection devices allows patients to select a device that suits their needs.

American Academy of Ophthalmology biosimilars guidance details

Biosimilars/General | Posted 01/07/2022

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].

No trends in biosimilars uptake levels in the US, reveals study

Biosimilars/Research | Posted 24/06/2022

There are no consistent trends in biosimilar uptake by order of market entry, care setting, or pricing, finds a new study published in the Journal of General Internal Medicine [1]. In addition, biosimilar uptake is generally lower than that reported for generic drugs in the US.

FDA approves pegfilgrastim and rituximab biosimilars

Biosimilars/News | Posted 24/06/2022

The US Food and Drug Administration (FDA) has approved the pegfilgrastim biosimilar Fylnetra (pegfilgrastim-pbbk) and the rituximab biosimilar Riabni (rituximab-arrx).

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.

Byooviz: first ophthalmology biosimilar launches in US

Biosimilars/News | Posted 17/06/2022

Biogen and Samsung Bioepis have launched Byooviz (ranibizumab-nuna) on the US market as the first ophthalmology biosimilar. It references Roche’s (Genentech’s) blockbuster therapy, Lucentis.

The impact of biosimilar insulins on public spending in Brazil

Biosimilars/Research | Posted 17/06/2022

The availability of insulin for the treatment of diabetes mellitus, a chronic disease that increases with age, and its financial sustainability are of general concerns, especially for universal healthcare systems, such as the Brazilian Unified Health System (Sistema Único de Saúde, SUS) [1]. This is why similar biotherapeutic products (produtos bioterapêuticos similares, SBP) can be a cost reduction strategy in improving access to essential supplies for the population. These drugs demand less investment and acquisition cost [2].

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.

Challenges with implementing benefit-sharing programmes for biologicals in Europe

Biosimilars/Research | Posted 10/06/2022

Diverse policies have been implemented across Europe to support the rational prescribing of biologicals. Policies limiting the reimbursement of high-cost pharmaceuticals and applying prescription quotas for ‘best-value’ biologicals (BVB) have often been combined with educational campaigns about biosimilars and with benefit-sharing (gainsharing) initiatives [1, 2].

Biocon: cancer biosimilar launch in Canada and US$90 million Malaysia deal

Biosimilars/News | Posted 10/06/2022

In May 2022, Biocon Biologics launched a bevacizumab biosimilar co-developed with Viatris (formerly Mylan), in Canada; and in April 2022, Biocon was awarded a three-year contract, worth US$90 million, by Malaysia's Ministry of Health

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].

Canada approves five biosimilars in last seven months

Biosimilars/News | Posted 03/06/2022

Since November 2021, Canada’s drug regulator, Health Canada, has approved no less than five biosimilars for the treatment of diabetes, cancer, osteoporosis and autoimmune conditions.

Successful increase of biosimilar adoption in a large integrated health delivery network

Biosimilars/Research | Posted 03/06/2022

Biologicals have revolutionized patient care across several therapeutic areas but are associated with significantly higher costs to patients and healthcare systems. Biosimilars offer the opportunity to reduce drug spending without compromising patient care. Medication utilization management (UM), a formulary management methodology, can be used to facilitate the adoption of biosimilars. Author Sophia Humphreys describes an innovative and strategic biosimilar adoption programme that was developed and implemented at Providence St Joseph Health [1]. Providence is a large integrated health system including 53 hospitals, 1,085 clinics and an annual drug spend of >US$1.2 billion.