Biosimilars

Phase I results for candidate adalimumab, etanercept and infliximab biosimilars

Biosimilars/Research | Posted 14/08/2015

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

Biosimilars/News | Posted 14/08/2015

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

Biosimilars/General | Posted 14/08/2015

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

Biosimilars/Research | Posted 07/08/2015

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

Biosimilars/Research | Posted 07/08/2015

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

Biosimilars/Research | Posted 31/07/2015

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

Biosimilars/General | Posted 31/07/2015

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

Biosimilars/General | Posted 31/07/2015

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

Biosimilars/Research | Posted 31/07/2015

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

Biosimilars/Research | Posted 03/07/2015

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

Biosimilars/News | Posted 03/07/2015

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

Biosimilars/General | Posted 03/07/2015

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

Biosimilars/General | Posted 26/06/2015

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/Research | Posted 26/06/2015

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

Biosimilars/Research | Posted 26/06/2015

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

Biosimilars/News | Posted 26/06/2015

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

Biosimilars in the US

Biosimilars/Research | Posted 19/06/2015

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

Biosimilars/General | Posted 19/06/2015

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

Biosimilars/Research | Posted 19/06/2015

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

Biosimilars/Research | Posted 12/06/2015

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.