Biosimilars

Key considerations for biosimilars in the US

Key considerations regarding biosimilars for payers in the US are discussed in a recent review [1]. The authors explore factors promoting the uptake of biosimilars, interchangeability and naming considerations, and challenges to uptake. 

Biocad advancing its non-originator biologicals in Russia

Russian biotechnology company Biocad has started an eculizumab study and has also registered its non-originator biological (BCD 057) in Russia.

ESMO survey highlights need for education and alignment

The results of a survey carried out by the European Society for Medical Oncology (ESMO) on biosimilars understanding in oncologists have highlighted the need for education and worldwide alignment [1].

Sandoz resubmits pegfilgrastim biosimilar to FDA

Sandoz, the generics division of Novartis, announced on 3 April 2019 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the US Food and Drug Administration (FDA).

Phase III clinical trials started for adalimumab biosimilars

Phase III clinical trials have been started for adalimumab biosimilars from Alvotech and Celltrion.

Samsung Bioepis invalidates Herceptin patent in Korea

Samsung Bioepis has won a patent invalidation suit against Roche’s Herceptin in Korea.

Biosimilars of pertuzumab

Pertuzumab is a monoclonal antibody that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, which prevents them from signalling in ways that promote cell growth and proliferation.

How can EU policymakers access the potential of biosimilars

Policymakers in Europe should introduce a long-term, multi-stakeholder framework to realize the full potential of off-patent biologicals and biosimilar drugs, according to the results of a series of roundtable discussions held with clinicians, government bodies and industry representatives [1].

Japanese approval for Lupin’s etanercept biosimilar

Indian generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 26 March 2019 that its joint venture YL Biologics and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry) had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its etanercept biosimilar YLB113 in Japan.

Comparison of autoinjectors for inflammatory joint or bowel disease

Imraldi is a biosimilar of the antitumour necrosis factor (TNF) monoclonal antibody adalimumab. It was approved in Europe in August 2017 for the treatment of various inflammatory conditions [1].

Biosimilars of somatropin

Somatropin or human growth hormone (hGH) is a peptide hormone that stimulates growth, cell reproduction and cell regeneration in humans and other animals. It is thus important in human development. It is a type of mitogen which is specific only to certain kinds of cells. Growth hormone is a 191-amino acid, single-chain polypeptide that is synthesized, stored and secreted by somatotropic cells within the lateral wings of the anterior pituitary gland.

Bio-Thera advances bevacizumab and tocilizumab copy biologicals

China-based Bio‑Thera Solutions (Bio‑Thera) has made a licensing agreement for its bevacizumab copy biological and has started a phase III trial for its tocilizumab copy biological.

FDA approves trastuzumab biosimilar Trazimera

Pharma giant Pfizer announced on 11 March 2019 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Roche’s Herceptin (trastuzumab).

Clinician biosimilar prescribing habits and need for education

At present, biosimilar prescribing and clinical use remain contingent on individual healthcare provider preferences. Although novel legislation and policy continue to promote biosimilar drug development, clinician hesitancies curtail biosimilar use in practice, thereby limiting overall market uptake. Findings from a recently published systematic review indicate that clinicians in Europe and the US do not primarily support the use of biosimilars as safe and effective therapies in patients already receiving originator biological treatment [1].

Celltrion wins biosimilar deals and Duopharma increases focus on biosimilars in SE Asia

Celltrion Healthcare (Celltrion) has won tenders to supply infliximab to Singapore and rituximab to Thailand, while CCM Duopharma Biotech Bhd (CCMD) aims to increase revenue contribution from its biosimilar products from 22% to over 25%.

Comparison of Brazilian regulations for follow-on biologicals with EMA, FDA and WHO

Authors Marcos Renato de Assis and Valdair Pinto outline the strengths and weaknesses of the Brazilian regulation on follow-on biologicals and compare  regulations in Europe, the US and the world [1].

China approves rituximab copy biological

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 22 February 2019 that it had approved Hanlikon, a rituximab copy biological.

UK’s NICE recommends pertuzumab with biosimilar trastuzumab

The UK’s National Institute for Health and Care Excellence (NICE) has recommended originator pertuzumab with intravenous biosimilar trastuzumab and chemotherapy for the treatment of breast cancer.

Copy biologicals approved in China

Last update: 2 April 2021

In China, the regulatory body for the approval of medicines, including biologicals, is the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA: simplified Chinese: 国家食品药品监督管理局).

Trastuzumab biosimilar PF 05280014 non-inferior to Herceptin

Results of a study of Pfizer’s trastuzumab biosimilar (PF 05280014) have shown that the biosimilar is non-inferior to the originator biological, Roche’s Herceptin (trastuzumab) [1].

Impact of proposed changes to FDA approach to biosimilars

In the Opinion article, Professor Sarfarez Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its guidance on biosimilar development [1]. Niazi’s proposals are consistent with the anti-regulatory political rhetoric and administrative actions that are becoming increasingly widespread in the US. In this article, Professor Pekka Kurki comments on some of Niazi’s proposals from a global perspective [2].

EC approval for bevacizumab biosimilar Zirabev

US-based drugmaker pharma giant Pfizer announced on 19 February 2019 that it had received European Commission (EC) approval for its bevacizumab biosimilar Zirabev (PF 06439535).

Positive phase I results for Mycenax’s tocilizumab biosimilar

Taiwanese biosimilars developer Mycenax announced on 31 December 2018 that results from the phase I study of its tocilizumab biosimilar, LusiNEX, had met its primary endpoints.

Green Shield Canada’s biosimilar switch pilot a success

Canadian not-for-profit healthcare benefits specialist, Green Shield Canada (GSC), announced in December 2018 that its biosimilar transition pilot had been successfully completed.

Mandatory and non-mandatory switching for biosimilars

Glintborg and co-authors responded to the comments made by Marc Scherlinger and Thierry Schaeverbeke on their paper ‘To switch or not to switch’, which reported the results of biosimilar etanercept switching in Denmark [1].

Monoclonal antibody copy biologicals accepted for review in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted applications for approval of two monoclonal antibody copy biologicals (IB 305 and HLX22).

Positive phase III results for rituximab biosimilar ABP 798

Biotech giant Amgen, and its partner Allergan, announced on 24 January 2019 positive data from a phase I/III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab).

Pfizer drops five preclinical biosimilar programmes

US pharma giant Pfizer confirmed on 15 January 2019 that it had terminated five of its preclinical biosimilar programmes after looking at the results of the company’s annual investment review.

Questions over DANBIO relevance for non-medical switching

Italian rheumatologists Fabrizio Cantini and Maurizio Benucci commented on the paper from Glintborg and co-authors ‘To switch or not to switch’, which reported the results of biosimilar etanercept switching in Denmark [1].

EC approval for pegfilgrastim biosimilar Fulphila

In January 2019, the pegfilgrastim biosimilar, Fulphila, received European Commission (EC) approval.

Biosimilar teriparatide approved for the treatment of osteoporosis

Osteoporosis is a modern day epidemic longevity has brought about and represents an enormous socioeconomic burden. Being largely asymptomatic the silent thief can get away with insidiously stealing the patient’s bones until, as a result of the relentless bone loss, fragility fractures inevitably occur. The first, so-called sentinel fracture is the forerunner of the devastating fracture cascade as any prior fracture translates into a two- to four-fold increase in the risk of sustaining a subsequent one within one year [1].

Three FDA approvals for Glenmark as it enters US branded dermatology market

Glenmark Pharmaceuticals Inc has been granted approval by the US Food and Drug Administration (FDA) for its generic versions of Zytiga, DermOtic oil and Qudexy XR, and has announced its entry into the US branded dermatology segment.

Safety surveillance of bevacizumab biosimilar (Bevax) in Argentina

Benefit-risk evaluations are mandatory throughout the life cycle of a therapeutic agent, to guarantee efficacy for the authorized indications without an unacceptable incidence of adverse effects. This monitoring can be carried out using pharmacovigilance (PhV) procedures, which are vital in the identification and prevention of adverse drug reactions (ADRs). Due to the inherent variability of bioproduction, this is of paramount importance for biological products, including biosimilars.

PanGen gains Malaysian approval for epoetin alfa biosimilar

South Korea-based biotechnology company PanGen Biotech (PanGen) announced on 7 February 2019 that Malaysia’s National Pharmaceutical Regulatory Agency has granted sales approval for Erisa, an epoetin alfa biosimilar.

European regulatory framework for approval of biosimilars – perspectives and future developments

Regulatory agencies around the world have reviewed and approved marketing authorization applications for biosimilars via specific marketing authorization procedures that vary between jurisdictions. In Europe, the European Medicines Agency (EMA) has already more than 10 years of experience with review of applications and approval of biosimilars for use in the European Union.

Long-term stability of trastuzumab biosimilar under various storage conditions

Trastuzumab (TTZ) is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2). In some cancers, including certain types of breast cancers and gastric cancers, HER2 is overexpressed, causing cancer cells to reproduce uncontrollably. TTZ can be used in the management of these cancers.

EMA approval for adalimumab biosimilars Idacio and Kromeya

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2019 that it had recommended granting marketing authorization for the adalimumab biosimilars Idacio and Kromeya.

Barriers and facilitators to biosimilar prescribing in the UK

At present, the rate of uptake of biosimilars is keenly debated among stakeholders in different healthcare specialties. Aladul et al. examined the perspectives on biosimilars among healthcare professionals (HCPs) from gastroenterology, rheumatology and diabetes specialities to shed light on barriers and facilitators to their prescribing in the UK [1]. In a qualitative, cross-sectional study, 22 HCPs (consultants, nurses and pharmacists) from five hospitals in the West Midlands were interviewed.

Australia’s PBAC recommends substitution of adalimumab biosimilars

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the adalimumab biosimilars Amgevita and Hadlima ‘should be treated as equivalent’ to the brand-name biological Humira on the Australian Pharmaceutical Benefits Scheme (PBS).

Tanvex BioPharma submits filgrastim biosimilar to Health Canada

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 16 January 2019 that it had submitted a biosimilar application to Health Canada for its proposed filgrastim biosimilar TX01.