Biosimilars
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.
