Biosimilars
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].
