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: 23 July 2024

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].