Biosimilars

FDA accepts application for etanercept biosimilar

Sandoz, the generics division of Novartis, announced on 2 October 2015 that the US Food and Drug Administration (FDA) had accepted its application for its etanercept biosimilar (GP2015).

Another infliximab switching trial started

In The Netherlands another study has been initiated into the effects of switching patients from originator infliximab to biosimilar infliximab.

Biosimilar epoetin-α as effective as originator in anaemia treatment

A study by researchers in Italy has concluded that biosimilar epoetin‑α appears to be comparable to originator epoetin‑α plus liposomal iron (Sideral), vitamin B12 and folates in terms of efficacy and safety for the treatment of refractory anaemia [1].

Biosimilar etanercept safe and effective

In a study funded by Samsung Bioepis (a Biogen and Samsung joint venture), their candidate etanercept biosimilar (SB4) has been found to be safe and well tolerated and to be equivalent in terms of efficacy compared to Enbrel (etanercept) in patients with rheumatoid arthritis (RA) [1].

Positive phase III results for bevacizumab biosimilar

Results of a phase III trial have demonstrated the similarity of partners Amgen and Allergan’s biosimilar bevacizumab candidate (ABP 215) to Avastin in patients with advanced non-small cell lung cancer (NSCLC).

Biosimilar production in Malaysia

Malaysian biotech firm Inno Bio Ventures has announced the signing of a memorandum of understanding (MoU) with Iranian firm Aryogen Biopharma. The agreement will lead to the production of the first Malaysian-made biosimilars for the local and regional market.

Dutch medicines agency aims to clarify biosimilars confusion

The Dutch Medicines Evaluation Board (MEB) has further clarified its position on biosimilars since its last update in March 2015. The MEB had previously raised concerns among patient groups and professional organizations with the announcement that biosimilars had no relevant differences to originators.

Biosimilar insulin launched in the UK

Eli Lilly and Boehringer Ingelheim announced on 26 August 2015 the UK launch of their biosimilar insulin glargine, Abasaglar.

Pharmacoeconomic modelling of biosimilars in the US

There are many challenges and uncertainties associated with the introduction of biosimilars to the US. To try and address these, authors from the Partnership for Health Analytic Research developed a conceptual framework to provide guidance in modelling biosimilars in the US setting [1].

Biosimilars applications under review by EMA – August 2015

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Comments on FDA’s guidance on naming biologicals

The US Food and Drug Administration (FDA) issued a draft guidance on the non-proprietary naming of biological products on 27 August 2015 [1], but not everyone is happy with the proposals made by the agency.

Biosimilar etanercept approved in South Korea

US pharma giant Merck and South Korean biosimilars maker Samsung Bioepis announced on 8 September 2015 the approval of their biosimilar etanercept product Brenzys by the Ministry of Food and Drug Safety (MFDS) in Korea.

Etanar as effective as adalimumab and infliximab in rheumatoid arthritis

A study of Etanar – an etanercept similar biotherapeutic product – has shown that it is as effective as adalimumab and infliximab in a cohort of patients with rheumatoid arthritis in a real-life setting [1].

Zarxio first biosimilar to be launched in US

The US has entered a new era in medicines with the historic launch of the country’s first biosimilar. Sandoz, the generics division of Novartis, announced on 3 September 2015 that it had launched its filgrastim biosimilar, Zarxio (filgrastim-sndz), in the US.

Phase III results of adalimumab biosimilar demonstrate equivalence

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 6 July 2015 phase III data demonstrating the ‘clinical equivalence’ of their adalimumab biosimilar (SB5) compared to the originator biological, Humira.

Non-originator bevacizumab candidate non-inferior to Avastin

Results of a phase III clinical study of Biocad’s non-originator bevacizumab candidate BCD-021 demonstrated ‘equivalence’ compared to the originator biological (Avastin) in patients with non-small cell lung cancer (NSCLC) [1].

Rituximab similar biologic launched in India

India-based generics maker Hetero Group (Hetero) announced on 3 August 2015 the launch of its product Maball, a ‘similar biologic’ of rituximab, in India.

Australian approval for infliximab biosimilar

South Korean biotechnology company Celltrion announced on 10 August 2015 that its partner Hospira had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for the infliximab biosimilar Inflectra.

Positive phase III results for candidate etanercept and infliximab biosimilars

Results of pivotal phase III clinical studies of candidate etanercept biosimilar SB4 and candidate infliximab biosimilar SB2 met their primary endpoints, demonstrating equivalence to the originator biological in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy [1, 2].

Overcoming hurdles to biosimilars cost savings in the US

The US approved its first biosimilar, Zarxio (filgrastim-sndz), on 6 March 2015 [1]. But how can the country overcome hurdles to the cost savings that can be achieved from these drugs? That is a question Sarpatwari and co-authors have tried to answer [2]. 

Phase I results for candidate adalimumab, etanercept and infliximab biosimilars

Results of phase I clinical studies of candidate adalimumab biosimilar SB5, etanercept biosimilar SB4 and infliximab biosimilar SB2, demonstrated equivalence safety profiles to their originator biologicals in healthy subjects [1-3].

Non-originator infliximab approved in Russia

South Korean biotechnology company Celltrion announced that it had received approval for its non-originator infliximab, Remsima, from Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav) on 13 July 2015.

Biosimilars approved in the US

Last update: 22 May 2025

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Biosimilars in the US: hurdles to cost savings

In light of the recent approval of the first biosimilar in the US, Zarxio (filgrastim-sndz), [1], Sarpatwari and co-authors look at the hurdles to cost savings for biosimilars in the US [2].

Safety of filgrastim biosimilars following stem-cell transplantation

The safety of granulocyte colony-stimulating factor (G-CSF; filgrastim) biosimilars was compared with that of the originator, Neupogen (Amgen), in a retrospective, single-institution study. Simona Bassi and co-authors at the Guglielmo da Saliceto Hospital in Piacenza, Italy, analysed data from patients with lymphoma or myeloma who had undergone autologous haematopoietic stem cell transplantation (HSCT) at the Guglielmo da Saliceto Hospital.

Approval of biosimilar insulins: regulations across the globe

Insulin analogue patent expiry is likely to mean that biosimilars will be submitted for licensing. In light of this, Heinemann and co-authors reviewed regulatory requirements for biosimilars, notably insulin, in several regions and countries [1].

Biosimilar infliximab offered to French hospitals at 45% discount

A major French hospital group has chosen biosimilar infliximab to treat its patients with rheumatoid arthritis, Crohn’s disease and psoriasis, after major discounts on the drug were offered to the group.

ACR position statement on biosimilars addresses naming and substitution

The American College of Rheumatology (ACR) has issued a position statement on biosimilars, reflecting its views on issues such as interchangeability, substitution, naming and post-marketing surveillance of biosimilars.

Efficacy of filgrastim biosimilars following stem-cell transplantation

The efficacy of granulocyte colony-stimulating factor (G-CSF; filgrastim) biosimilars has been assessed in terms of engraftment following stem-cell transplantation. Time to engraftment was compared following treatment with the originator, Neupogen (Amgen), and with biosimilars in a retrospective, single-institution study.

Norway, biosimilars in different funding systems

Norway has approved biosimilar versions of the biologicals somatropin, epoetin, filgrastim and infliximab. Epoetin and filgrastim are included in a national tender for drugs used in hospitals, in which prices can be reduced by up to 89%. Regional health care is responsible for funding drugs used in hospitals and at home, and it is their responsibility for obtaining the best prices. The H-prescription system in Norway works best to maximize biosimilar competition, as exemplified by the approach taken for infliximab. However, the effect of existing biosimilars on prescriptions has varied [1].

Biosimilars licensing agreements for AMP and Formycon

German biosimilars companies AMP Biosimilars (AMP) and Formycon have both made out-licensing agreements for their candidate biosimilars.

Polish firm gets EIB loan for biosimilars development

The European Investment Bank (EIB) is lending Euros 45 million (around Zloty 185 million) to the largest Polish manufacturer of pharmaceuticals, Polpharma, for its research into, and development of, biosimilars.

Concerns raised over Australian decision to substitute biosimilars

In May 2015, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) recommended that originator biologicals could be substituted by biosimilars by physicians and pharmacists [1]. However, pharmacy companies, as well as physician and patient groups have reacted with concern over the decision.

Approval of biosimilars in rheumatology

Biosimilars are approved following a regulatory pathway different to that of generics, as they are not molecularly identical to their reference products. Currently, only one biosimilar is approved by the European Medicines Agency (EMA) for the treatment of rheumatological diseases: an infliximab biosimilar, which is commercialized as Remsima/Inflectra [1]. With this approval in mind, author Gilberto Castañeda-Hernández and co-authors discuss what rheumatologists should know about biosimilars [2].

Real-life results for Inflectra compared to Remicade

Results of a post-marketing clinical study of infliximab biosimilar Inflectra demonstrated equivalent effectiveness compared to the originator biological (Remicade) in patients with rheumatoid arthritis and ankylosing spondylitis when switched from Remicade [1].

Ranibizumab similar biologic launched in India

Indian generics maker Intas Pharmaceuticals (Intas) announced on 19 June 2015 the launch of its ranibizumab similar biologic in India.

Biosimilars in the US

The US Food and Drug Administration (FDA) approved the country’s first biosimilar Zarxio (filgrastim-sndz) on 6 March 2015 [1]. But how will biosimilars be classified in the future and how will savings for biosimilars be realized in the US? These are questions Sarpatwari and co-authors sought to answer [2].

Australia’s PBAC recommends substitution of biosimilars

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that biosimilars are suitable for substitution at the pharmacy level.

Remsima shows comparable safety and efficacy in IBD patients

South Korean biotechnology company Celltrion presented results of clinical experience for its infliximab biosimilar Remsima (CT-P13) at Digestive Diseases Week (DDW) 2015, which was held in Washington DC, USA, on 17–19 May 2015.

Biosimilars for the treatment of Crohn’s disease

The introduction of targeted biological therapies has improved the treatment of immune inflammatory arthritis and other autoimmune diseases, in particular, Crohn’s disease (CD). The monoclonal antibodies infliximab and adalimumab have shown beneficial effects in patients with CD and high disease activity. The forthcoming introduction of biosimilars is expected to improve access to these expensive medications with an expected reduction in price ranging from 20 to 40 per cent of the present cost.