Biosimilars

Positive phase I results for Fresenius Kabi’s pegfilgrastim biosimilar

Biosimilars/Research | Posted 07/12/2018

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 9 October 2018 that results from two phase I studies of its pegfilgrastim biosimilar (MSB11455) had met their primary endpoints.

EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo

Biosimilars/News | Posted 30/11/2018

In November 2018, pegfilgrastim biosimilars, Pelmeg and Ziextenzo, received European Commission (EC) approval.

Switching from reference products to biosimilars: the European perspective

Biosimilars/Research | Posted 30/11/2018

The number of biosimilars receiving marketing authorization has grown steadily over the past several years [1, 2] and is expected to continue growing in the future. Particularly when biologicals are prescribed for the treatment of chronic diseases, switching patients from the originator biological to the biosimilar is increasingly becoming an option, allowing for a considerable reduction of public health expenditure. This article [3] provides an overview of current approaches in Europe to switching patients to treatment with biosimilars.

Comparative results for CT-P10 in low-tumour burden FL

Biosimilars/Research | Posted 30/11/2018

According to research in patients with low-tumour burden follicular lymphoma (FL), the efficacy and pharmacokinetics of rituximab biosimilar CT‑P10 are equivalent or non-inferior to the originator rituximab, Roche’s MabThera/Rituxan [1].

Safety of originator and biosimilar epoetin alfa drugs

Biosimilars/Research | Posted 23/11/2018

Researchers from Italy carried out a study to compare the safety profile of biosimilars with respect to the reference product in a nephrology setting. The results confirm the comparable safety profiles of originator and biosimilar epoetin alfa drugs when used in patients receiving dialysis [1].

Insulin glargine biosimilars launched in UK and South Korea

Biosimilars/News | Posted 23/11/2018

November 2018 has seen the launch of insulin glargine biosimilars in both the UK and South Korea.

Tanvex BioPharma submits filgrastim biosimilar to FDA

Biosimilars/News | Posted 23/11/2018

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 1 October 2018 that it had submitted its first biosimilar application to the US Food and Drug Administration (FDA). The application is for its proposed filgrastim biosimilar TX01.

Positive phase III data for adalimumab biosimilar Cyltezo

Biosimilars/Research | Posted 23/11/2018

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 12 September 2018 positive phase III data for its adalimumab biosimilar, Cyltezo [1]. The results, according to Boehringer Ingelheim ‘confirm that Cyltezo is equivalent to Humira, with no clinically meaningful differences in efficacy safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis’.

Another adalimumab copy biological accepted for review in China

Biosimilars/News | Posted 16/11/2018

The China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA) has accepted another application for approval of an adalimumab copy biological, this time from Innovent Biologics (Innovent).

Phase I study suggests similarity of omalizumab biosimilar

Biosimilars/Research | Posted 16/11/2018

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 25 July 2018 that results from a phase I study suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between Glenmark’s proposed omalizumab biosimilar GBR 310 and the originator product Xolair (omalizumab).

FDA approves adalimumab and pegfilgrastim biosimilars

Biosimilars/News | Posted 09/11/2018

The US Food and Drug Administration (FDA) announced on 30 October 2018 and on 2 November 2018 that it had approved adalimumab and pegfilgrastim biosimilars, respectively.

Inflectra may not be less expensive than Remicade in US

Biosimilars/Research | Posted 09/11/2018

According to research carried out in the US, the cost of the infliximab biosimilar Inflectra (infliximab-dyyb) was only moderately less expensive than the originator biological Remicade (infliximab) in treating rheumatoid arthritis (RA) and exceeded US$14,000 annually under Medicare^# Part D*. In addition, out-of-pocket costs for patients taking Inflectra may be more than US$1,700 higher than for patients taking Remicade.

Phase III study of biosimilar pegfilgrastim confirms safety and effectiveness in patients on myelosuppressive chemotherapy

Biosimilars/Research | Posted 09/11/2018

Canada-based Apobiologix, a division of Apotex, reported results of an international, phase III, randomized, double-blind clinical trial to demonstrate biosimilarity between the Apotex pegfilgrastim biosimilar (Apo-Peg; Lapelga) and reference product Neulasta (Amgen) [1].

Adalimumab biosimilars Amgevita and Imraldi launched in Europe

Biosimilars/News | Posted 02/11/2018

In October 2018, two adalimumab biosimilars have been launched in the European Union (EU). Amgen announced the European launch of its adalimumab biosimilar, Amgevita and Biogen announced the launch of its adalimumab biosimilar Imraldi.

Clinical and real-world data for switching to biosimilars

Biosimilars/Research | Posted 02/11/2018

The evidence and issues associated with switching from originator biological disease-modifying antirheumatic drugs (DMARDs) to biosimilars are discussed by authors from French universities and hospitals [1].

Merck gains US infliximab contract but drops insulin glargine biosimilar

Biosimilars/General | Posted 02/11/2018

US pharma giant Merck (known as MSD outside the US and Canada) has signed a deal with the US Department of Veterans Affairs (VA) for its infliximab biosimilar, Renflexis. However, it is pulling out of a deal for insulin glargine biosimilar Lusduna.

Real-life clinical effectiveness of Razumab in retinal vein occlusion

Biosimilars/Research | Posted 02/11/2018

Authors from Intas Pharmaceuticals presented data from a subgroup analysis of the RE-ENACT study (retrospective, multicentre, observational pooled study on wet age-related macular degeneration [wet AMD], diabetic macular oedema, and retinal vein occlusion) [1]. The RE-ENACT study evaluated the effectiveness of the ranibizumab similar biologic Razumab in Indian patients with retinal vein occlusion (RVO).

Trastuzumab similar biologic Hervycta launched in India

Biosimilars/News | Posted 02/11/2018

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 July 2018 the launch of its product Hervycta, a ‘similar biologic’ of trastuzumab, in India.

Mylan gains nod for Ogivri and launches Hulio in Europe

Biosimilars/News | Posted 26/10/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced at its meeting on 18 October 2018 that it had recommended granting marketing authorization for the trastuzumab biosimilar Ogivri.

Originator biologicals and biosimilars under attack in UK and Japan

Biosimilars/General | Posted 26/10/2018

Originator biologicals makers and biosimilars makers are finding themselves facing litigation in both the UK and Japan.

Mass spectrometry comparison of Remicade and Remsima

Biosimilars/Research | Posted 26/10/2018

The US entered the era of biosimilars in 2015 with its very first US Food and Drug Administration (FDA) approved filgrastim biosimilar Zarxio (filgrastim-sndz) [1]. Since then, FDA has approved 11 more biosimilars [2]. Nevertheless, one concern with respect to the manufacturing of biosimilars is that every company has its own proprietary manufacturing process, which could potentially lead to differences in drug properties. Consequently, the debate on how ‘similar’ the biosimilar is to the originator still remains controversial. Thus, a comprehensive but rapid characterization platform that can validate any clinically meaningful differences is required. In this regard, Pisupati et al. [3] carried out a study comparing the reference product Remicade (infliximab) with the first US monoclonal antibody (mAb) biosimilar Remsima (Europe)/Inflectra (US) by incorporating state-of-the-art mass spectrometry-based multiple-attribute monitoring (MAM).

Switching to etanercept biosimilar SB4 safe and effective in a hospital setting

Biosimilars/Research | Posted 26/10/2018

Authors of a study carried out at a UK hospital found switching to etanercept biosimilar SB4 to be safe and effective [1].

FDA reviews adalimumab biosimilar SB5

Biosimilars/News | Posted 26/10/2018

Samsung Bioepis announced on 27 September 2018 that the regulatory submission for its proposed adalimumab biosimilar (SB5) had been accepted by the US Food and Drug Administration (FDA).

Expediting FDA approvals for biosimilars

Biosimilars/Research | Posted 19/10/2018

A number of recommendations for the US Food and Drug Administration (FDA) to simplify biosimilar licensing laws, and thus make biosimilars more accessible, are offered in a recent review [1]. Recommendations include allowing smaller batch sizes for testing, encouraging substitution for naïve patients, and removing the requirement for bridging studies.

FDA advisers recommend approval of rituximab biosimilar CT-P10

Biosimilars/News | Posted 19/10/2018

US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for CT‑P10, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). If approved by FDA, this would be the first rituximab biosimilar approved in the US.

Phase III trial for subcutaneous Remsima completed

Biosimilars/Research | Posted 19/10/2018

Celltrion Healthcare (Celltrion) announced on 29 August 2018 that it had completed a phase III study with the subcutaneous (SC) version of its infliximab biosimilar Remsima (CT‑P13).

Comments on FDA’s public meeting on biosimilars

Biosimilars/General | Posted 12/10/2018

Comments made at the US Food and Drug Administration’s (FDA) recent meeting on biosimilars included a call for interchangeability information in the Purple Book, criticism of FDA’s use of arbitrary suffixes and a request to waive bridging studies for biosimilars.

Two darbepoetin alfa biosimilars submitted to Japan’s PMDA

Biosimilars/News | Posted 12/10/2018

Two South Korean firms have announced that they have submitted applications for approval of their proposed darbepoetin alfa biosmilars to Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA).

Reasons for switching to biosimilars and immunogenicity

Biosimilars/Research | Posted 12/10/2018

Authors from French universities and hospitals discussed the evidence and issues associated with switching from originator biological to biosimilars [1].

Stakeholder perspectives on biosimilars in oncology

Biosimilars/Research | Posted 05/10/2018

Monoclonal antibody biosimilars represent a novel advance in the field of oncology, and their integration into routine clinical practice present challenges for clinicians, nurses, patients and regulators. Researchers therefore investigated the perspectives stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist on optimizing the uptake of monoclonal antibody biosimilars in the treatment of cancer [1].

EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca

Biosimilars/News | Posted 05/10/2018

In September 2018, adalimumab biosimilar, Hulio, and pegfilgrastim biosimilar, Udenyca, received European Commission (EC) approval.

Pharmacokinetics of CT-P6 in patients with HER2+ early-stage breast cancer

Biosimilars/Research | Posted 05/10/2018

Researchers from Celltrion presented data that support the pharmacokinetic (PK) similarity between trastuzumab biosimilar CT‑P6 and originator trastuzumab (Herceptin) [1].

Biocon’s biosimilars plant gains clearance from FDA

Biosimilars/General | Posted 05/10/2018

India-based biologicals specialist Biocon has stated that its biosimilars plant has received a clean bill of health, indicating that it is now compliant with US Food and Drug Administration (FDA) manufacturing requirements.

Bioequivalence of bevacizumab biosimilar (BEVZ92) versus Avastin in mCRC patients

Biosimilars/Research | Posted 28/09/2018

Researchers from mAbxience presented data that supports the pharmacokinetic (PK) bioequivalence between bevacizumab biosimilar BEVZ92 and originator bevacizumab (Avastin) as first-line treatment in combination with fluorouracil, leucovorin and oxaliplatin (FOLFOX) or fluorouracil, leucovorin, and irinotecan (FOLFIRI). in patients with metastatic colorectal cancer (mCRC) [1].

EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo

Biosimilars/News | Posted 28/09/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 September 2018 that it had recommended granting of marketing authorizations for the pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo.

Adalimumab copy biologicals accepted for review in China

Biosimilars/News | Posted 28/09/2018

China Food and Drug Administration (CFDA) has accepted applications for approval of adalimumab copy biologicals from Hisun Pharma (Hisun) and Bio‑Thera Solutions (Bio‑Thera).

Recommendations for biosimilars in rheumatology in the Middle East

Biosimilars/Research | Posted 28/09/2018

The increasing availability of biosimilars in Middle Eastern regions may provide an opportunity to increase the number of rheumatology patients who have access to traditionally more expensive biologicals. However, as well as a lack of real-world data on the use of biosimilars in practice, the availability of ‘intended copies*’ in the region may undermine physician confidence in prescribing legitimate biosimilars. There is a need for regional recommendations for healthcare professionals to ensure that biosimilars can be used safely.

Samsung Bioepis sued over trastuzumab biosimilar but win for Celltrion’s biosimilar Inflectra

Biosimilars/General | Posted 28/09/2018

Roche’s Genentech has sued Samsung Bioepis regarding its trastuzumab biosimilar, but Celltrion has won its patent battle against Johnson & Johnson (J&J).

Improving understanding of biotherapeutics and biosimilars

Biosimilars/General | Posted 21/09/2018

Additional information on biosimilars and biotherapeutics have been published in Europe.

Selection of quality attributes and test methods in biosimilarity assessment

Biosimilars/Research | Posted 21/09/2018

Biosimilar development starts with a detailed characterization of the quality profile of the chosen reference product, to establish targets for cell line and process development, according to author Vandekerckhove and colleagues [1]. This characterization requires a careful determination of the range of variability for all relevant product quality attributes of the reference product, as well as an understanding of their relative importance, to ensure appropriate focus on the most important attributes. Following process development, similarity of the biosimilar candidate with the reference product must be demonstrated in comprehensive analytical studies. This first step in the demonstration of biosimilarity provides the most sensitive measurement of differences; and is instrumental in deciding the direction of further product development. Meticulous design of the analytical similarity programme is therefore critical to the success of biosimilar development.